Implements and coordinates clinical trials conducted at the Washington Hospital Center and/or its affiliates in conjunction with Good Clinical Practice (GCP) and Food & Drug Administration (FDA) regulations. Possesses knowledge in clinical research and organizational skills with the ability to manage multiple responsibilities and activities with close attention to detail.
Principal Duties and Responsibilities :
1. Coordinates protocol implementation for clinical trials, including, but not limited to, preparation and submission of regulatory documents, patient screening and recruitment, informed consent, study enrollment, and participant follow-up.
2. Communicates with sponsors, investigators, clinical monitors and colleagues to ensure effective clinical trial implementation and progress.
3. Initiates and maintains required clinical and regulatory files.
4. Participates in conferences, departmental meetings, continuing education, investigator meetings, site initiation, interim monitoring and closeout study visits as assigned.
5. Administers and/or dispenses investigation agents as needed.
6. Monitors patients’ study progress to fulfill protocol and sponsor requirements.
7. Completes clinical course of study subjects as required per protocol, including, but not limited to, laboratory tests vital sign measurement, EKGs, health status assessment and adverse event monitoring.
8. Prepares and analyzes regular reports of research activity, including MRI monthly billing forms, IRB continuations & closures, and patient enrollment logs.
9. Assists CRI staff and/or MRI investigators on study related activities, as required and/or as time allows.
10. Seeks opportunities to develop fund of knowledge in clinical study areas.
11. Performs late stay requirement on a rotational basis, to ensure completion of study activities
12. May be required to work off-hours & weekends for study-related activities.
13. Train new clinical research staff on the basics of clinical trials, basic clinical data analysis and serve as a resource when needed
14. Assist in the supervision and assessment of Junior Research Staff during probationary evaluation.
15. Perform other duties as assigned
Education: RN with licensure or eligibility for licensure in the State of Maryland or equivalent experience
Experience: Three years in clinical setting, and 2 years in clinical research preferred.
MedStar Health Research Institute - 23 months ago