University of Rochesterhttp://universityofrochester.jobs2023-06-24 04:41:08RochesterUniversity of RochesterUnited StatesUSA2023-06-24 04:41:08GENERAL PURPOSE:
Responsible for the implementation and coordination of a prospective and retrospective research study in the Endocrinology Division, including protocol development/revision, patient database management, data input, and synthesis of relevant literature. Work will also include conducting phone visits and follow ups associated with human subject research; the work may be extended to assistance with the design of a prospective clinical trial.
**RESPONSIBILITIES:**
Prospective study, A (part 1): Diabetes Prevalence and Associated Risk Factors in Patients with Schizophrenia, Schizoaffective or Bipolar Disorder on 2nd Generation Antipsychotic Medications.
+ Review and revise study protocols and related procedures as well as correct documentation in compliance with the RSRB
+ Review clinic schedule to identify potential subjects for recruitment. This requires good understanding of the research study requirements and use of independent decision-making and assessment skills. Perform medical chart review to identify specific criteria for inclusion, conducts case screening and identification of eligible subjects
+ Determine what patients may be eligible to participate in, explain the details of the study to the subject by phone and have them consider consenting
Communicate with research subjects regarding scheduled study visits, follow up and results
Prospective study, A (part 2): Diabetes Prevalence and Associated Risk Factors in Patients with Schizophrenia, Schizoaffective or Bipolar Disorder on 2nd Generation Antipsychotic Medications.
+ Maintain REDCap database, and review patient charts in eRecord for data collection in REDCap database
+ Assist in statistical analysis of collected data
Assist in the writing of a research paper
Retrospective study, B: Impact of 2nd Generation Antipsychotic Medication Use on Metabolic and Cardiovascular Health.
+ Maintain REDCap database, and review patient charts together with other study team members in eRecord for data collection in REDCap database
+ Assist in statistical analysis of collected data
Assist in the writing of a research paper
Prospective clinical trial planning, C: Is Therapy with SGLT2-inhibitor or GLP-1 Analogue Accepted and Efficacious in Obese Patients with Diabetes and Depression on Antipsychotic Medications (APM)?
+ Assist with implementing integrated diabetes care clinic
+ Assist with developing prospective research proposal and IRB protocols
Assist in writing a review paper
**QUALIFICATIONS:**
+ Bachelor’s degree and one year of experience in clinical research or equivalent combination of education and experience. Prefer a degree in life sciences, health administration or a related discipline as well as prior clinical research experience required.
+ Or equivalent combination of education and experience required
+ Proficiency in computer software applications including Microsoft Office programs such as Excel, Outlook, and Word, Databases such as RedCap, statistical analysis programs such as R, SPSS, etc. Ability to learn and master existing department applications and future software applications and programs. Excellent communication, interpersonal and organizational skills; highly persistent and energetic professional style; self-motivation and drive to reach goals/objectives. Strong attention to detail, ability to digest and understand the study, and the strong ability to use good judgment in assessing each individual’s comprehension preferred.
The University of Rochester is committed to fostering, cultivating, and preserving a culture of equity, diversity, and inclusion to advance the University’s mission to Learn, Discover, Heal, Create – and Make the World Ever Better. In support of our values and those of our society, the University is committed to not discriminating on the basis of age, color, disability, ethnicity, gender identity or expression, genetic information, marital status, military/veteran status, national origin, race, religion/creed, sex, sexual orientation, citizenship status, or any other status protected by law. This commitment extends to the administration of our policies, admissions, employment, access, and recruitment of candidates from underrepresented populations, veterans, and persons with disabilities consistent with these values and government contractor Affirmative Action obligations.
**How To Apply**
All applicants must apply online.
_EOE Minorities/Females/Protected Veterans/Disabled_
**Pay Range**
Pay Range: $ 18.89 - $ 26.44 Hourly
_The referenced pay range represents the minimum and maximum compensation for this job. Individual annual salaries/hourly rates will be set within the job’s compensation range, and will be determined by considering factors including, but not limited to, market data, education, experience, qualifications, expertise of the individual, and internal equity considerations._
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**Location:** School of Medicine & Dentistry
**Full/Part Time:** Part-Time
**Opening:**Rochester, NY246466New YorkNYHuman Subject Res Coord INoneF96AC04C50D5439ABE9C33692B8AC2D8http://universityofrochester.jobs/F96AC04C50D5439ABE9C33692B8AC2D823RochesterUniversity of RochesterUnited StatesUSA2023-06-08 05:14:13Responsibilities
**General Purpose:**
Coordinates the activities associated with human subject research.
**Responsibilities:**
Coordinates the administrative details required to initiate and conduct human subject research, including receiving, distributing and explaining study information, such as protocol and human subject recruitment materials, to immediate team members and relevant others.
Assists in human subject recruitment and screening activities, including reviewing study site patient databases and office records for patients that meet the protocol inclusion criteria. May participate in developing recruitment strategies. May conduct telephone interviews to screen potential study candidates. Reviews medical chart history with Principal Investigator to verify inclusion criteria are met before enrollment.
Ensures all immediate and extended team members understand and adhere to all aspects of all approved training manuals, protocols, procedures, and standards for documentation and communication. Under general direction from the Principal Investigator (PI), trains staff on details of protocol, including inclusion and exclusion criteria, informed consent procedures, study activities, source documentation and case report form (CRFs) completion, and adverse event reporting.
Reviews and documents the dispensing and returning of study materials, such as study drugs and devices. Ensures additional training is provided to ensure changes to protocol and documents are communicated and adhered to.
Acts as liaison with Sponsor’s Monitor to provide data clarifications, reviews study protocols, ensures thorough understanding and communication, responds to questions that arise during the study, communicates and documents adverse events as advised by the PI and ensures regulatory and other documents, such as consent forms and CRFs, are complete, accurate, and available for review. Communicates with Sponsor to clarify data queries to determine report format. Prepares for, participates in, and serves as liaison for scheduled Sponsor monitoring visits (i.e. pre-study inspection, initiation, on-going and close out visits).
Keeps current with all federal, state, sponsor, and institutional policies and laws, standard operating procedures, and guidelines and makes recommendations. Demonstrates accountability for continuous learning in accordance with Good Clinical Practice standards and guidelines. Keeps current with industry standards, best practices, and trends in therapeutic areas relevant to research studies. Makes recommendations and implements changes as appropriate.
Other duties as assigned
**Qualifications:**
+ Bachelor’s degree
+ or equivalent combination of education and experience (preferred)
+ No previous experience
+ Or equivalent combination of education and experience eg. an Associate’s degree and completion of 6 months in the Human Subject Research Coordinator Trainee program
+ Word processing and data analysis software (preferred)
The University of Rochester is committed to fostering, cultivating, and preserving a culture of equity, diversity, and inclusion to advance the University’s mission to Learn, Discover, Heal, Create – and Make the World Ever Better. In support of our values and those of our society, the University is committed to not discriminating on the basis of age, color, disability, ethnicity, gender identity or expression, genetic information, marital status, military/veteran status, national origin, race, religion/creed, sex, sexual orientation, citizenship status, or any other status protected by law. This commitment extends to the administration of our policies, admissions, employment, access, and recruitment of candidates from underrepresented populations, veterans, and persons with disabilities consistent with these values and government contractor Affirmative Action obligations.
**How To Apply**
All applicants must apply online.
_EOE Minorities/Females/Protected Veterans/Disabled_
**Pay Range**
Pay Range: $ 18.89 - $ 26.44 Hourly
_The referenced pay range represents the minimum and maximum compensation for this job. Individual annual salaries/hourly rates will be set within the job’s compensation range, and will be determined by considering factors including, but not limited to, market data, education, experience, qualifications, expertise of the individual, and internal equity considerations._
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**Location:** School of Medicine & Dentistry
**Full/Part Time:** Full-Time
**Opening:**Rochester, NY246077New YorkNYHuman Subject Res Coord INone0ECD162BB848495F9993DF8CB4DB7D5Ehttp://universityofrochester.jobs/0ECD162BB848495F9993DF8CB4DB7D5E23RochesterUniversity of RochesterUnited StatesUSA2022-10-08 06:06:12Responsibilities
**General Purpose:**
The Human Subject Research Coordinator (HSRC) will provide study coordination of a national study with four years to go funded by the Department of Defense (DOD). This study will be in collaboration with study investigators at URMC, academic medical institutions including Harvard Medical School, University of South Florida and University of California at Irvine, and other study staff. This study includes two sequential clinical trials aimed at assess the use of digital interventions for co-occurring depression and insomnia among U.S. military service Veterans.
This position is a full-time position, with specific responsibilities (described below). The HSRC will be responsible for implementation and oversight of the study protocols under the supervision of the Project Coordinator and the Principal Investigator. This includes assisting with recruitment activities, fulfilling and tracking participant payments and associated vouchers, assist with team meeting logistics and communication throughout the project period, assist with preparation of monthly, quarterly and annual reports to the study sponsor, assist with IRB continuing review and amendment submissions, assist with developing and maintaining analytic data files, and assist with preparation of dissemination reports and products including literature reviews, editing text and preparing/managing manuscript submissions.
This is a grant-funded role and will run for a 12-month period, with possibility for extension, depending on the needs of the project..
**Responsibilities:**
**Project administration** : Coordinates the administrative details required to initiate and conduct human subject research, including receiving, distributing and explaining study information, such as protocol and human subject recruitment materials, to immediate team members and at partner sites. Maintains a project timeline that tracks closely the Statement of Work, tracking due dates for individual items and reporting on progress at team meetings.
**Recruitment** : Active in developing human subject recruitment materials with the study recruitment partners and assuring the eConsent process is working properly and developing and maintaining a subject identification file that is kept separate from the study data file.
**Data Management** : Works with the Project Coordinator to ensure all data are secured within approved parameters and procedures. Assists with download of data and preparation of de-identifed dataset to be sent to the data analysis site at Harvard.
**Dissemination:** Assists with development of manuscripts and final reports and manages the submission process for these.
**Liaison** : Acts as liaison with study staff at the other study sites at Harvard, South Florida and UC-Irvine to track study activities, coordinates all study team meetings and maintains agendas and minutes.
**Regulatory/Reporting** : Keeps current with all federal, state, sponsor, and institutional policies and laws, standard operating procedures, and guidelines and makes recommendations. Demonstrates accountability for continuous learning in accordance with Good Clinical Practice standards and guidelines such as attending SCORE monthly meetings. Makes recommendations and implements changes as appropriate.
Takes the primary role in prepping all reports due to the Study Sponsor and to the Research Subjects Review Board. Maintains a calendar of all due dates. Assists the Principal Investigator and Project Coordinator with these submissions.
**Qualifications:**
+ Bachelor’s degree required; or equivalent combination of education and experience preferred
+ No previous experience required
+ Or equivalent combination of education and experience e.g. an Associate’s degree and completion of 6 months in the Human Subject Research Coordinator Trainee program required.
+ Word processing and data analysis software
+ Experience conducting sleep research
The University of Rochester is committed to fostering, cultivating, and preserving a culture of equity, diversity, and inclusion to advance the University’s mission to Learn, Discover, Heal, Create – and Make the World Ever Better. In support of our values and those of our society, the University is committed to not discriminating on the basis of age, color, disability, ethnicity, gender identity or expression, genetic information, marital status, military/veteran status, national origin, race, religion/creed, sex, sexual orientation, citizenship status, or any other status protected by law. This commitment extends to the administration of our policies, admissions, employment, access, and recruitment of candidates from underrepresented populations, veterans, and persons with disabilities consistent with these values and government contractor Affirmative Action obligations.
**How To Apply**
All applicants must apply online.
_EOE Minorities/Females/Protected Veterans/Disabled_
**Pay Range**
Pay Range: $ 18.89 - $ 26.44 Hourly
_The referenced pay range represents the minimum and maximum compensation for this job. Individual annual salaries/hourly rates will be set within the job’s compensation range, and will be determined by considering factors including, but not limited to, market data, education, experience, qualifications, expertise of the individual, and internal equity considerations._
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**Location:** School of Medicine & Dentistry
**Full/Part Time:** Full-Time
**Opening:**
**Schedule:**Rochester, NY240798New YorkNYHuman Subject Res Coord INone657CCB82FE044158B5CECB2B92C2458Fhttp://universityofrochester.jobs/657CCB82FE044158B5CECB2B92C2458F23RochesterUniversity of RochesterUnited StatesUSA2022-05-26 06:10:47Responsibilities
**JOB DESCRIPTION:**
Provide support to the overall coordination of the funded and non-funded clinical studies within EIOH. The individual must be able to work independently with minimal supervision. Excellent interpersonal skills, writing skills, and computer skills are required. Knowledge of Recap required. Knowledge of RSRB policies, procedures and submission process extremely helpful.
**RESPONSIBILITIES:**
+ Acts as liaison with various departments involved in study to provide data clarifications, reviews study protocols, ensures thorough understanding and communication, responds to questions that arise during the study, communicates and documents adverse events as advised by the PI and ensures regulatory and other documents, such as consent forms and CRFs, are complete, accurate, and available for review. Communicates with study team/PI to clarify data queries to determine report format.
+ Coordinates the administrative details required to initiate and conduct human subject research, including receiving, distributing and explaining study information, such as protocol and human subject recruitment materials, to immediate team members and relevant others.
+ Reviews and documents the dispensing and returning of study materials, such as study drugs and devices. Ensures additional training is provided to ensure changes to protocol and documents are communicated and adhered to. Responsible for safe transport and logging of clinical specimens delivered to laboratories.
+ Provide data clarifications; respond to questions that arise during study activities; communicate and documents adverse events as advised by the Principal Investigator; ensure regulatory and other documents (such as consent forms and CRFs) are complete, accurate, and available for review and quality assurance.
+ Enters study data and ensures for completeness of data and/or performs the duplicate data entry. Analyze data collected by research studies. Assist the PI or other team members in the development, research, compilation and editing of presentations and publications of study findings. Run Redcap reports as requested by study team and PI.
+ Keep current with all federal, state, sponsor, and institutional policies and laws, standard operating procedures and guidelines, and make recommendations. Demonstrate accountability for continuous learning in accordance with Good Clinical Practice standards and guidelines. Keep current with industry standards, best practices, trends in therapeutic areas relevant to research studies, and then make recommendations and implement changes as appropriate.
Other duties as assigned.
**QUALIFICATIONS:**
+ Bachelor’s degree candidate
+ 1 years of experience in human subject research coordination; or an equivalent combination of education and experience required.
+ Proficiency with Microsoft Office required
The University of Rochester is committed to fostering, cultivating, and preserving a culture of equity, diversity, and inclusion to advance the University’s mission to Learn, Discover, Heal, Create – and Make the World Ever Better. In support of our values and those of our society, the University is committed to not discriminating on the basis of age, color, disability, ethnicity, gender identity or expression, genetic information, marital status, military/veteran status, national origin, race, religion/creed, sex, sexual orientation, citizenship status, or any other status protected by law. This commitment extends to the administration of our policies, admissions, employment, access, and recruitment of candidates from underrepresented populations, veterans, and persons with disabilities consistent with these values and government contractor Affirmative Action obligations.
**How To Apply**
All applicants must apply online.
_EOE Minorities/Females/Protected Veterans/Disabled_
**Pay Range**
Pay Range: $ 18.89 - $ 26.44 Hourly
_The referenced pay range represents the minimum and maximum compensation for this job. Individual annual salaries/hourly rates will be set within the job’s compensation range, and will be determined by considering factors including, but not limited to, market data, education, experience, qualifications, expertise of the individual, and internal equity considerations._
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**Location:** Eastman Dental Center
**Full/Part Time:** TAR
**Opening:**
**Schedule:**Rochester, NY237772New YorkNYHuman Subject Res Coord INone383428116F8144DC819F31F4D6073B15http://universityofrochester.jobs/383428116F8144DC819F31F4D6073B1523RochesterUniversity of RochesterUnited StatesUSA2021-12-17 08:13:45GENERAL PURPOSE:
Coordinates the activities associated with human subject research.
**RESPONSIBILITIES:**
+ Coordinates the administrative details required to initiate and conduct human subject research, including receiving, distributing and explaining study information, such as protocol and human subject recruitment materials, to immediate team members and relevant others.
+ Assists in human subject recruitment and screening activities, including reviewing study site patient databases and office records for patients that meet the protocol inclusion criteria. May participate in developing recruitment strategies. May conduct telephone interviews to screen potential study candidates. Reviews medical chart history with Principal Investigator to verify inclusion criteria are met before enrollment.
+ Conducts visits to ensure research participant adherence with protocol requirements, such as taking of medications, proper use of device, and/or other interventional activities, to document adverse events and report to senior study staff, PI, Institutional Review Board (IRB), Sponsor, and/or any other required recipients or entities. Ensures all data are collected and secured within approved parameters and procedures.
+ Ensures all immediate and extended team members understand and adhere to all aspects of all approved protocols, procedures, and standards for documentation and communication. Under general direction from the Principal Investigator (PI), trains staff on details of protocol, including inclusion and exclusion criteria, informed consent procedures, study activities, source documentation and case report form (CRFs) completion, and adverse event reporting.
+ Reviews and documents the dispensing and returning of study materials, such as study drugs and devices. Ensures additional training is provided to ensure changes to protocol and documents are communicated and adhered to.
+ Acts as liaison with Sponsor’s Monitor to provide data clarifications, reviews study protocols, ensures thorough understanding and communication, responds to questions that arise during the study, communicates and documents adverse events as advised by the PI and ensures regulatory and other documents, such as consent forms and CRFs, are complete, accurate, and available for review. Communicates with Sponsor to clarify data queries to determine report format. Prepares for, participates in, and serves as liaison for scheduled Sponsor monitoring visits (i.e. pre-study inspection, initiation, on-going and close out visits).
+ Keeps current with all federal, state, sponsor, and institutional policies and laws, standard operating procedures, and guidelines and makes recommendations. Demonstrates accountability for continuous learning in accordance with Good Clinical Practice standards and guidelines. Keeps current with industry standards, best practices, and trends in therapeutic areas relevant to research studies. Makes recommendations and implements changes as appropriate.
Other duties as assigned
**QUALIFICATIONS:**
+ Bachelor’s degree required
+ 1 year of experience in human subject research coordination required
+ or equivalent combination of education and experience required
+ Word processing and data analysis software preferred
**How To Apply**
All applicants must apply online.
_EOE Minorities/Females/Protected Veterans/Disabled_
**Pay Range**
Pay Range: $ 18.89 - $ 26.44 Hourly
_The referenced pay range represents the minimum and maximum compensation for this job. Individual annual salaries/hourly rates will be set within the job’s compensation range, and will be determined by considering factors including, but not limited to, market data, education, experience, qualifications, expertise of the individual, and internal equity considerations._
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**Location:** School of Medicine & Dentistry
**Full/Part Time:** Full-Time
**Opening:**
**Schedule:**Rochester, NY233833New YorkNYHuman Subject Res Coord INoneBAF591094B2641C0B053084B3BEAE337http://universityofrochester.jobs/BAF591094B2641C0B053084B3BEAE33723RochesterUniversity of RochesterUnited StatesUSA2021-11-23 06:50:06GENERAL PURPOSE:
This is a position in the Pediatric Infectious Division to assist in pediatric clinical and translational studies, including studies of pediatric COVID-19 vaccines. This person will be responsible for recruitment and have administrative responsibilities, including screening and recruiting subjects, performing informed consenting and interviews, completing data entry, and performing medical chart reviews. He/she will review study protocols, ensure thorough understanding and communication, respond to questions that arise during the study, communicate and document adverse events as advised by the Principal Investigator, and ensure regulatory and other documents (such as consent forms and CRFs) are complete, accurate and available for review.
**RESPONSIBILITIES:**
+ Screening, recruitment, and monitoring of study subjects, including medical chart review, screening patients to ensure enrollment criteria are met and explaining the study to potentially eligible families.
+ Conducting study visits with subjects, including interviews and obtaining informed consent.
+ Ensuring patient compliance with the study protocol and performing completion of source documents, eCRFs, and follow up phone calls. Data QC to ensure data accuracy and answering study queries.
+ Documenting and reporting adverse events to the investigators, IRB, and sponsor
+ Other duties as assigned
**QUALIFICATIONS:**
+ Bachelor’s Degree or equivalent experience required
+ 2 years’ experience directly related to clinical research preferred
+ Ability to work effectively with children and families. Flexible in approach and appreciates the demands of a fast-paced, constantly evolving project preferred.
**How To Apply**
All applicants must apply online.
_EOE Minorities/Females/Protected Veterans/Disabled_
**Pay Range**
Pay Range: $ 18.89 - $ 26.44 Hourly
_The referenced pay range represents the minimum and maximum compensation for this job. Individual annual salaries/hourly rates will be set within the job’s compensation range, and will be determined by considering factors including, but not limited to, market data, education, experience, qualifications, expertise of the individual, and internal equity considerations._
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**Location:** School of Medicine & Dentistry
**Full/Part Time:** Full-Time
**Opening:**
**Schedule:**Rochester, NY233292New YorkNYHuman Subject Res Coord INone9178A02BA2B746A085DAD0D3E7DC5D16http://universityofrochester.jobs/9178A02BA2B746A085DAD0D3E7DC5D1623RochesterUniversity of RochesterUnited StatesUSA2021-05-13 04:42:57Responsibilities
**Job summary:**
The University of Rochester Neurorestoration Institute is seeking an individual for the position of Clinical Coordinator. The main role of the Clinical Coordinator will be to operate & maintain the day-to-day operational duties of their assigned clinical trials and clinical research study database. The primary role of this position is to support the Clinical Research OT position in the University of Rochester Neurorestoration Institute.
Job responsibilities include, but are not limited to the following:
**Duties and responsibilities:**
**_20% of time will be spent:_**
+ Assist the Director and OT in the preparation of study budgets, research related cost estimate forms, and initiation of all new research studies and trials
+ In collaboration with the other clinical coordinators, develop day-to-day plan and procedures for data collection as well as data confidentiality and data security for research coordinators and techs.
+ Develop plans for protocol implementation, identify necessary resources and request as appropriate. This includes instruments, equipment and staff.
+ Determine recruitment objectives and develop systems to monitor and track achievement
**_20% of job will consist of:_**
+ Assistance in the preparation and submission of annual reports and regulatory information to funding and regulatory agencies
+ Assist the regulatory team with the preparation of IRB applications and ongoing IRB activities
+ Preparation and submission of regulatory documentation to the regulatory bodies as relevant
+ Assist investigators with validation and editing of collected data
+ Analyze study data and assist in preparing manuscript
+ Regular collaboration with the PI and other research staff
+ Maintenance of study documents and files, such as regulatory binders and CVs etc.
+ Completion of GCP, HIPPA and applicable regulatory training
+ Complete certification requirements for assigned protocols
**_20% of assignments include:_**
+ Screen designated schedules or patient lists for eligible subjects
+ Approach and verify eligibility subjects
+ Scheduling of research visits
+ Training of patients on robots and oversight of patients on these protocols
+ Processing, transporting and shipping of biological specimens as assigned and following of instructions as delineated in the protocol or manual of operations.
+ Completion of study documents and files; some examples might include case report forms, worksheets and medical record notes.
+ Maintain confidentiality of documents and files such as HIPPA.
+ Maintenance of detailed study files & complete paper case report forms & uploading of electronic case report forms/data within 48 hours of collection
+ Obtain fully informed consent of all eligible trial & study patients in accordance to IRB, local & federal statutes
**_20% of duties will be:_**
+ Collect, process, and assist in the compilation and verification of research data, samples, and/or specimens (following strict protocol and detailed instructions); data is collected through medical chart review, recording of physiologic, imaging data, structured interviews with patients and family members, and conducting all follow up visits in strict accordance with protocol specifications
+ Working with regulatory coordinator in submitting new protocols, amendment, renewals, and other regulatory submissions to IRB, sponsor, FDA, and other regulatory bodies.
+ Instruct, oversee, and ensure appropriate coordination of day-to-day aspects of study related procedures for research coordinators and techs, including, but not limited to: scheduling study subject visits and procedures, data entry, preparation for research visits, research visit documentation, maintenance of regulatory binders and study files, creation and/or maintenance of source documentation, and preparation for monitoring visits, site initiation/closeout visits and audits as needed
+ Instruct, oversee & ensure appropriate coordination of research staff handling & processing of human bio-specimens such as blood, saliva, and stool
**_10% of duties:_**
+ Carry out required staff training and provide the direct supervision for two patient care technicians
+ Provide on-boarding training and guidance for all new research staff
+ Collaborate with patient care technicians and other study members to ensure consistent measures and protocols are being administered
+ Informing relevant clinical staff regarding subject protocol participation.
+ Clear and effective communication with potential study subjects, clinicians, other health care providers, ancillary staff, and research office staff
**_10% of job duties:_**
+ Working with the other research managers in developing and overseeing the “on call” system for research staff to cover all active clinical studies
+ Monitor and track achievements of clinical trials
+ Scheduling follow-ups and documentation with patients as well as informing patients of other clinical trials and services offered
+ Assist in other research related activities and projects as needed
**Minimum education:**
Requires a minimum of a Bachelor's Degree or equivalent. Prior clinical trial experience preferred.
**Minimum related experience:**
This opportunity is ideal for individuals who will be applying to residency, foreign medical graduates, or individuals with a graduate health sciences degree and a minimum of 4+ years of clinical research experience.
**Minimum computer skills:**
+ Working knowledge of MS Office
+ Experience with statistical analysis programs (ie. SAS, SPSS, STATA) is preferred
**General skills:**
Qualifications for Candidates include but are not limited to the following:
+ Candidate will ensure integrity and compliance with all regulatory, institutional, and departmental requirements
+ The ability to take initiative and work independently is required, and the ability to effectively work in a complex matrix is required
+ Outstanding technical writing skills and understanding of medical terminology/research
+ Advanced understanding of data management processes
+ Ability to analyze and interpret scientific data and skilled in the use of computerized systems and databases
+ Ability to understand and follow scientific research protocol and procedure
+ Excellent communication skills (both verbal and written) required
+ Exceptional organizational, interpersonal, and presentation skills
+ Ability to understand and follow complex, detailed technical instructions
+ Ability to foster a cooperative & collaborative work environment
+ The ability to be flexible with scheduling is mandatory; willingness to work evenings and weekend hours in unusual or emergent situations required.
**How To Apply**
All applicants must apply online.
_EOE Minorities/Females/Protected Veterans/Disabled_
**Pay Range**
Pay Range: $ 18.89 - $ 26.44 Hourly
_The referenced pay range represents the minimum and maximum compensation for this job. Individual annual salaries/hourly rates will be set within the job’s compensation range, and will be determined by considering factors including, but not limited to, market data, education, experience, qualifications, expertise of the individual, and internal equity considerations._
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**Location:** School of Medicine & Dentistry
**Full/Part Time:** Full-Time
**Opening:**Rochester, NY228649New YorkNYHuman Subject Res Coord INone56AFAFD895AE40239C0232A8D780AF40http://universityofrochester.jobs/56AFAFD895AE40239C0232A8D780AF4023RochesterUniversity of RochesterUnited StatesUSA2021-05-08 04:22:51Responsibilities
**Position Summary** :
The Human Subject Research Coordinator (HSRC) will provide essential research support and study coordination for several studies in the Department of Emergency Medicine. Provides assistance to the Principal Investigator(s) and works as an integral part of the study team.
**Supervision / Direction** :
Kian Merchant-Borna, EM Research Faculty
**Specific Responsibilities** :
Under general direction, the HSRC is responsible for planning, coordinating, and carrying out recruitment, scheduling, and data collection for assigned studies. Supports daily operations for research studies and clinical trials as needed. HSRC recruits, schedules, and consents human subjects for participation in research. This research will mostly involve working with patients (children and adults) in the Emergency Room, and may also involve working with student-athletes. While the work will be carried out under general supervision, the HSRC will work independently and complete study procedures with human subjects independently. May serve as back-up to the primary Health Project Coordinator.
Recruits, schedules, and conducts subject visits for research studies in accordance with study protocols, coordinating these visits with the Principal Investigator. May perform activities including but not limited to participant consent, primary data collection, and cognitive assessments as required by protocol. Works with ancillary departments to schedule imaging or other study procedures. Resolves questions and concerns received from study subjects or sponsor, triaging to the Principal Investigator as necessary.
Understands and provides training on protocols, procedures, documentation, and use of study materials to subjects and team members as appropriate. Ensures compliance, follows up and communicates as needed. Keeps current with study-specific training.
Serves as the liaison between cross-functional research teams, study sponsors, and IRB to facilitate communication, resolves issues (e.g., resolve queries from research visits), and enhance collaboration. Schedules, prepares for, and attends study sponsor monitor meetings in accordance with protocol. Represents the University and Principle Investigator at study meetings as needed.
Supports laboratory operations, including processing/handling specimens, sample shipping, maintaining shipping logs and databases, supporting cleanliness of lab, determining supply requirements for new projects, monitoring inventory levels and ordering supplies, designing and building sample collection kits for studies, and additional duties as assigned.
Manages the regulatory details for assigned research studies. Prepares and maintains regulatory and study documentation. Manages and submits amendments and continuing reviews for IRB approval. Ensures all regulatory requirements are met and documented.
Develops and/or manages databases and case report forms (CRF’s) for research studies. Ensures data is entered in a timely manner and database(s) is up-to-date.
Attends training sessions and other educational opportunities related to clinical research in order to keep current with Good Clinical Practice guidelines, federal and institutional policies and laws, industry standards and best practices and trends in relevant areas.
**Qualifications** :
Bachelor’s degree and one year (cumulative) of experience in human subject research coordination; or equivalent combination of education and experience. Must have excellent communication skills, including written communication, and be exceptionally organized, trustworthy, and coachable. Experience collecting biospecimen samples (blood, saliva, etc.), or willingness to learn. Valid driving license and reliable transportation required\
**How To Apply**
All applicants must apply online.
_EOE Minorities/Females/Protected Veterans/Disabled_
**Pay Range**
Pay Range: $ 18.89 - $ 26.44 Hourly
_The referenced pay range represents the minimum and maximum compensation for this job. Individual annual salaries/hourly rates will be set within the job’s compensation range, and will be determined by considering factors including, but not limited to, market data, education, experience, qualifications, expertise of the individual, and internal equity considerations._
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**Location:** School of Medicine & Dentistry
**Full/Part Time:** Part-Time
**Opening:**
**Schedule:**Rochester, NY228598New YorkNYHuman Subject Res Coord INoneDDB12D28FD674B19B1AC7749BDE578C4http://universityofrochester.jobs/DDB12D28FD674B19B1AC7749BDE578C423RochesterUniversity of RochesterUnited StatesUSA2019-12-21 04:27:07Responsibilities
**Position Summary:**
Coordinates all aspects of assigned research studies associated with human subject research. Provides assistance to the Principal Investigator and works as an integral part of the study team.
**Responsibilities:**
Recruits, schedules, and conducts subject visits for research studies in accordance with study protocols, coordinating these visits with the Principal Investigator. May perform activities including but not limited to participant consent, vital signs, cognitive assessments, or mobility tests, as required by protocol. Works with ancillary service departments to schedule drug dispensing, lab assessments, and/or study imaging. Resolves questions and concerns received from study subjects, triaging to the Principal Investigator as necessary.
Understands and provides training on protocols, procedures, documentation, and use of study materials to subjects and team members as appropriate. Ensures compliance, follows up and communicates as needed. Keeps current with study-specific training.
Serves as the liaison between cross-functional research team, study sponsors, and IRB to facilitate communication, resolves issues (e.g., resolve queries from research visits), and enhance collaboration. Schedules, prepares for, and attends study sponsor monitor meetings in accordance with protocol. Represents the University and Principle Investigator at study meetings as needed.
Manages the regulatory details for assigned research studies. Prepares and maintains regulatory and study documentation. Manages and submits amendments and continuing reviews for IRB approval. Ensures all regulatory requirements are met and documented.
Develops and/or manages databases for research studies. Ensures data is entered in a timely manner and database(s) is up-to-date.
Attends training sessions and other educational opportunities related to clinical research in order to keep current with Good Clinical Practice guidelines, federal and institutional policies and laws, industry standards and best practices, and trends in relevant therapeutic areas.
**Qualifications:**
Bachelor’s degree and 1 year of experience in human subject research coordination; or equivalent combination of education and experience. Knowledge of word processing and data analysis software preferred.
Preferred Qualifications
Knowledge of word processing, spreadsheets, and electronic data capture (EDC) software preferred. Must have excellent communication skills.
**How To Apply**
All applicants must apply online.
_EOE Minorities/Females/Protected Veterans/Disabled_
**Pay Range**
Pay Range: $ 18.89 - $ 26.44 Hourly
_The referenced pay range represents the minimum and maximum compensation for this job. Individual annual salaries/hourly rates will be set within the job’s compensation range, and will be determined by considering factors including, but not limited to, market data, education, experience, qualifications, expertise of the individual, and internal equity considerations._
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**Location:** School of Medicine & Dentistry
**Full/Part Time:** Full-Time
**Opening:**
**Schedule:**Rochester, NY219761New YorkNYHuman Subject Res Coord INone7092FEC0AB004B18ABC31AFB9D2BF329http://universityofrochester.jobs/7092FEC0AB004B18ABC31AFB9D2BF32923