University of Rochester Human Subject Research Coordinator, Neurosurgery - 231778 in Rochester, New York
Human Subject Research Coordinator, Neurosurgery Job ID 231778Location School of Medicine & Dentistry Full/Part Time Full-Time Favorite Job Regular/Temporary Regular Opening
Full Time 40 hours Grade 053 Department of NeurosurgerySchedule
8 AM-4:30 PMResponsibilities
The position is for an experienced human subject research coordinator to join a dynamic , cross functional team working in the field of translational clinical research. The research coordinator will be an integral member of an adjudication committee assisting in determining subject eligibility for a global registration trial. The successful candidate will also assist in coordinating other industry- and investigator-initiated research studies in surgical study populations .
Applicants must be able to work independently and have clinical research experience . This role oversees and coordinates human subject research activities for single or multiple sites .
Develops , implements and evaluates recruitment strategies , information and data systems and study management systems . Participates in the planning , development and implementation of study design , budgets , protocols , consent forms , processes and policies that may include multiple therapeutic areas . Participates in the development , review and approval of case report forms (CRFs) and study-specific procedure manuals and documents .SUPERVISION AND DIRECTION RECEIVED:
Under the direct supervision of the Principal Investigator with oversight from the Vice Chair for Clinical Research
Adjudication Committee (45%)
In a timely manner , reviews documentation received from sites in study database to ensure receipt of all required information . (10%)
Conducts preliminary review to ascertain if subject meets eligibility requirements to be included in trial. (10%)
Forwards thoroughly reviewed information on to expert clinicians for final eligibility determination , assisting with answering questions they may have as applicable . (5%)
Maintains high degree of knowledge on study protocol , SOPs , and chronic pain syndrome under study . (5%)
Maintains continuous communication with adjudication committee and all relevant stakeholders . (5%)
Directs the activities of other study coordinator staff and relevant others to gather , compile and analyze study information . ( 5%)
Coordinates and monitors financial data for budget and variance reporting and for compliance with all institutional requirements for adequate system controls . ( 5%)
Study Coordinator Duties (50%)
Supports research studies including:
Study Visits : Recruits , consents , schedules, and conducts research subject visits in accordance with study protocol , coordinating these visits with the Principal Investigator. May draw blood , processes samples , and performs testing such as ECG and treadmill tests, depending on the protocol. Coordinates and documents dispensing and returning of study drugs/materials .
Regulatory Oversight: Oversees and manages the regulatory details for assigned research studies . Manages and submits study applications, amendments , and continuing reviews for IRB approval (local and central) .
Data Management: Develops and/or manages databases (e . g . , EDC , REDCap) for research studies. Ensures data entered and queries responded to in a timely manner .
Liaison : Serves as the liaison between cross-functiona l research team , study sponsors , and IRB to facilitate communication , resolve issues , and enhance collaboration .
Trains research coordinators and other staff on activities associated with conducting human subject research specific to study protocols and generally in compliance w i th Good Clinical Practice (GCPs) guidelines and sponsor requirements.
Continuing Educat i on (5% )
Demonstrates accountability for continuous learning related to clinical research .
Keeps current with study-specific training , including understanding specific details of study protocol , all relevant sponsor and institutional policies , standard operating p r ocedures , and guidelines .
Participates in tra i ning sessions and other educational opportunities related to clinical research in order to keep current with Good Clinical Practice guidelines , federal and state polices and laws , institutional certifications, industry standards and best practices , and trends in relevant therapeutic areas .
Other projects and job duties as assigned .
Bachelor ' s degree and three years of experience in human subject research coordination required; or an equivalent combination of education and experience.
RN degree and phlebotomy training preferred .
Professional research coordinator certification (e . g ., SoCRA or ACRP) preferred .
Knowledge of word processing , spreadsheets , and electronic data capture (EDC) software preferred .
Must be independent and organized , have excellent communication skills (including wr i tten communication) , strong attent i on to detail , and strong interpersonal skills .
T he University of Roche s ter i s an E q u al O p portunit y E m ployer M ino ri tie s/ F emale s / Protected V eterans / Disabled.
How To Apply
All applicants must apply online.
EOE Minorities/Females/Protected Veterans/Disabled