Human Subject Res Coord II
This position supports the Cardiology Division as a research coordinator in pharmaceutical and device clinical trials. Typical duties will include but are not limited to: conducting study protocols as the primary coordinator, with responsibility for study start-up activities such as WIRB and RSRB submissions, recruitment and enrollment and entire conduct of given study under the direction of the Principal Investigator. Ensures compliance with all applicable regulatory and institutional requirements and standards as well as compliance with Good Clinical Practice (GCP) guidelines and sponsor requirements. On-call responsibilities are expected, dependent on individual study protocols. This position will assist the administrative efforts of the Manager/Senior Health Project Coordinator and Director of the Research to assess clinical feasibility of newly proposed projects, evaluating study protocols regarding standard of care and research oriented tasks, evaluating time and effort needed to complete clinical tasks and study procedures and visits related to conduct of the studies toward assessment and preparation of budgets for the studies. This person will be committed to providing high quality research efforts on the Cardiology Division's behalf.
Conducts visits to ensure research participant adherence with protocol requirements. Dispensing of investigational medications and devices, performing procedures as required by protocols (obtaining lab specimens, performing electrocardiograms, collecting data while observing electrophysiology, diagnostic, interventional cardiology procedures, exercise testing, drawing of bloods, etc.).
Recruiting/screening/consenting/enrollment of patients, record reviews and interviews. Reviews medical chart history with PI to verify inclusion criteria are met before enrollment
Coordinates the administrative details required to initiate and conduct human subject research, such as IRB submissions and regulatory document collection.
Receiving, distributing, and explaining study information, including protocol, and human subject recruitment materials to immediate team members and relevant others
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, trains staff on details of protocol, including inclusion and exclusion criteria, informed consent procedures, study activities, process for source documentation and case report form (CRFs) completion, and adverse event reporting.
Filling out case report forms, creating patient instructions and calendars, scheduling patient appointments, and assisting the investigators as needed.
Prepares for, participates in and serves as a liaison for sponsor monitoring visits. Develops good working relationship with sponsors to foster a positive research environment and attend study Investigator/Coordinator meetings as required for study start-up.
Collection and Reporting of adverse and serious adverse events to sponsor.
Other duties as assigned
Bachelor’s degree in a health-related field required
3 year of experience in human subject research coordination required;
or equivalent combination of education and experience required
Experience as Human Subject Research Coordinator I experience
Word processing and data analysis software required
Clinical skills in phlebotomy, EKG’s and cardiac stress testing preferred
Professional Research Coordinator Certification (SoCRA or ACRPP preferred
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How To Apply
All applicants must apply online.
EOE Minorities/Females/Protected Veterans/Disabled
Pay Range: $ 45,800 - $ 64,100 Annually
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.
Location: School of Medicine & Dentistry
Full/Part Time: Full-Time
Opening: Full Time 40 hours Grade 053
Schedule: 8 AM-4:30 PM