University of Rochester Sr Human Subject Res Coord - 217172 in Rochester, New York
Sr Human Subject Res Coord
School of Medicine & Dentistry
Full Time 40 hours Grade 055 Pediatrics M&D Neonatology
8 AM-5 PM; WKENDS/HOL
The individual must have the ability to work independently under the guidance of the Principal Investigator of each Division as well as working closely with the Institutional Review Board. The position will direct multiple study projects interfacing regionally and nationally to ensure the deliverables for each study are met and protocols adhered.
Lead Study Coordinator Role – Study Specific Responsibilities
Supervise the screening, enrollment and follow-up of study subjects including data extraction from chart, data entry into database, sample collection and chart review by organizing essential tasks and assigning them to study staff.
Act as a lead study coordinator between the principal investigators, regulatory authority, IRB, governmental agencies, study sponsor, study personnel, clinical unit directors, and administrative offices within the Department of Pediatrics and Neonatology as well as other departments involved in the research to answer any study related questions by maintaining an extensive understanding of all aspects of the studies to be able to direct other study staff in performance of duties.
Act as a lead study coordinator between the University of Buffalo and University of Rochester clinical research personnel as well as with the Data Coordinating Center (DCC)
Serve as lead study coordinator for all internal communication and external communication concerning study specific questions giving direction independent of project director
Set deadlines for study staff to ensure data is collected and entered into database in timely manner
Supervise the implementation of research studies at multiple sites. Work with multiple PIs, coordinators at regional and national sites to establish study start-up and on-going maintenance. Intermittently requiring travel to organizational study meetings
Communicate with regional and national sites on study progress/problems. In this role, serve as the lead study coordinator between the sponsors, departmental, and non-departmental personnel to assure that institution is in compliance with study guidelines as detailed on the individual study protocols.
Attend with PI, or represent the PI, at sponsor Investigator Meetings for new study start-up, annual study maintenance meetings, or for on-going study maintenance. Meetings can be local, regional or national.
Develop systems to hold study staff accountable to protocol specifics /record that each study participant has each test, data and specimen collection completed in required time range.
Provide direct management of subjects and staff interaction with subjects per Good Clinical Practice Guidelines (GCP), sponsor protocol guidelines and local standard of care guidelines.
Construct analytic reports and figures to prepare for data analysis.
Prepare data summaries for submission to Sponsors and/or FDA as needed and for eventual publication or presentations at scientific or study sponsored meetings.
Serve as the data manager for the joint University of Rochester and University of Buffalo center by providing direction to study nurses and investigators on status of data submission.
Monitor study protocols with respect to recruitment and attrition, methodology, and data acquisition and management providing direction to study staff and investigators on areas of concern or focus.
Lead study team in the planning and implementation of study start up and evaluate necessities throughout study
Lead and direct monitoring site visits before, during and after study is completed.
Assist and promote development of clinical studies with other relevant Paediatric Divisions (eg. PCICU, PICU, Obstetrics and Gynecology)
Regulatory and Compliance
Manage and monitor IRB submissions (including applications, amendments and annual progress reports) submitted by various Neonatology personnel including clinical research coordinator and fellows
Manage and review regulatory documents (including protocol, informed consent forms, recruitment materials and subject communication) prepared by clinical research coordinator and fellows
Prepare and submit applications, amendments, and annual progress reports for the IRB (Institutional Review Board) in compliance with the specified timelines as required by the UR RSRB (Research Subject Review Board) Office, and the sponsor or cooperative groups for multiple federally funded and investigator initiated studies
Develop and revise diverse study protocols (guidelines for study conduct), study designs, recruitment materials, and consent forms for review by multi-site Investigators.
Develop systems to hold study staff accountable and record that each study participant has each test, data and specimen collection completed in required time range as specified in protocol and informed consent to ensure compliance
Develop quality control measures to ensure accuracy and reliability of data collected and to ensure compliance with protocols and informed consent
Supervise enrollment for several federally funded studies and oversee all study adverse events and submit accurately per time line required by Sponsors and the IRB
Serve as lead study coordinator between IRB and study staff to communicate regulatory guidance and compliance information regarding applications, amendments and progress reports.
Put practices into place for study staff to ensure that all staff are using proper consent forms, protocols, manual of procedures and standard operating procedures.
Supervise on-going research activities, protocols and consent forms to ensure proper version control and timely and accurate compliance with University, sponsor and other regulatory bodies.
Maintain phone and email communication with IRB, sponsors, data coordinating centers, departmental, and non-departmental personnel concerning study status, compliance and regulatory affairs
Prepare and supervise Neonatology staff (clinical research coordinator) for audits for the Department of Pediatrics PCRO, the IRB, and study monitors.
Coordinate and oversee Ancillary Committee IRB reviews related to the Division of Neonatology
Prepare monthly financial reports to evaluate which cost factors are within specified parameters and which need more focus.
Prepare and analyze study budget/expenditures for spending and financial compliance.
Review enrolled subjects for billing risk and reverse charges where appropriate
Make recommendations to project director about spending distribution in relationship to established budget.
Analyze study account ledgers to ensure spending is within budget parameters and charges are placed appropriately.
Develop invoices to sponsors for reimbursement for study services provided under capitation.
Serve as lead study coordinator working with other departments to ensure that all services performed for study procedures are billed appropriately and compensation is received.
Serve as lead study coordinator working with pediatric finance to ensure proper compliance with departmental, IRB and sponsor financial requirements and communicating this information to study staff.
Establish guidelines for compensation to assure that financial compliance is achieved.
Train and provide supervision/guidance to new study staff maintaining day to day oversight of activities
Serve as a mentor and provide ongoing training to study staff in the division as needed.
Assist in monitoring progress (or lack of progress) for new staff. Assist to identify strengths and weaknesses to optimize staff contribution to study work.
Identify personnel issues and areas of needed training and additional support; assist in making recommendations to Principal Investigator (PI) and/or supervisor to resolve personnel issues.
Supervise the day-to-day duties and operations of students, part time study personnel and clinical research coordinator.
Coordinate and direct the work of study research nurses and coordinators, report unresolved difficulties to PI and/or supervisor
Provide feedback to PI and/or supervisor for yearly reviews for study personnel working with pediatric HR administration
Participate in the interview process, meeting each candidate and providing PI with direction on current research needs in the division
Conduct weekly meetings with study staff to review progress, concerns and questions.
Education and Communication
Assist in education programs including Neonatal Fellows program and Research Ambassador Program
Coordinate and lead regional and national teleconferences
Assist in production of research newsletters and research related communication
Bachelor’s degree with major course work in an appropriate health, social or technical field, three to five years of related experience; or an equivalent combination of education and experience. Certified Clinical Research Coordinator, higher degree such as Masters and/or nursing degree desirable/preferred.
Must possess expertise in the area of Research Subjects Review Board (RSRB), Office for Human Research Protections (OHRP) and/or Federal Drug Administration clinical research regulations. Must possess highly effective communication, organization and decision-making skills as well as maintain accurate and complete records on all subjects for sponsor review.
At a local level, this individual must have the ability to devise the necessary strategic methods required to assure the success of the research projects as well as the ability to interact effectively with a wide range of individuals including patients/subjects, parents of patients/subjects, bedside nurses, administrative nurses, adolescents, peers, clinical/ researchers at all levels.
Perform limited clinical assessments, perform assessments of family stresses that might interfere with study compliance, obtain specimens (e.g., blood, urine) by assisting nursing staff, develop and monitor the logistics of subject enrollment, be persistent and flexible in assuring ongoing subject cooperation, and efficiently collect, record, enter, quality check and report data.
Must have a strong understanding of study design and statistics. High level of experience with all Microsoft Office Products as well as Project is required.
How To Apply
All applicants must apply online.
EOE Minorities/Females/Protected Veterans/Disabled