Human Sub Research Spec II
About The Position
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. This position is 80% on-site, 20% remote. This person will be committed to providing high quality research efforts on the Cardiology Division's behalf.
Requirements
- Bachelor's degree and 2 years of experience in human subject research coordination required
- Or equivalent combination of education and experience
- Word processing and data analysis software required
Nice To Haves
- If applicable, department specific experience required
- Experience as a Phlebotomist preferred
- Clinical skills in phlebotomy, and EKG’s preferred
- SOCRA - Certification In Clinical Research upon hire preferred
- Association of Clinical Research Professionals (ACRP) upon hire preferred
Responsibilities
- 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
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
