Assists in the research efforts with the opportunity to implement and coordinate clinical research protocols in compliance with GCP and FDA regulations.
Principal Duties and Responsibilities
1. Coordinate and complete research for CRI trials in accordance with FDA and GCP guidelines.
2. Coordinate protocol implementation and document processing for clinical trials,
Including but not limited to, patient screening & recruitment, informed consent process, study enrollment and patient follow up.
3. Communicates with sponsors, investigators, clinical monitors and colleagues to
ensure effective clinical trial implementation and progress.
4. Assist with management and maintenance required clinical and regulatory files.
5. Participate in conferences, departmental meetings, continuing education, investigator
meetings, site initiation, interim monitoring and closeout study visits as assigned.
6. Administer and/or dispense investigational agents as needed. Manage drug or device accountability logs.
7. Monitor patients study progress to fulfill protocol and sponsor requirements. (Complete all study documents in a timely manner).
8. Obtain necessary supporting documentation of clinical events, including, but not limited to discharge summaries, progress notes, consult notes, ultrasounds, laboratory tests, vital signs measurement, EKGs, health status assessment and adverse event monitoring.
9. Prepare and analyze regular reports of research activity, including MRI monthly billing forms, IRB continuations & terminations, and patient enrollment logs.
10. Assist personnel in the research department on study related activities, as required.
11. Complies with institutional and departmental policies and procedures.
12. Consistently demonstrates support for compliance in the performance of job duties and responsibilities by a) developing and maintaining knowledge of, and performing job functions in compliance with, rules, regulations, policies, and statutes that affect his/her job; b) maintaining knowledge of and performing job functions in compliance with MedStar Health and MedStar Health Research Institute policies and procedures; and c) reporting compliance concerns in an appropriate and timely manner.
13. Performs other duties as assigned.
Education: Bachelors degree in a health related field.
Experience: Previous work in clinical research setting.
Other: Strong organizational skills with the ability to manage multiple duties with close attention to detail required. Computer skills (Microsoft Office) preferred.