Research Associate
MedStar Health Research Institute 3 reviews - Hyattsville, MD

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Nature and Scope of Position :

Implements and coordinates clinical trials at the MCCRC or MedStar Health affiliates in conjunction with GCP and 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 :

Coordinates protocol implementation for clinical trials, including but not limited to:

1. Administrative §

Works with the Principal Investigator and Administrative Director to develop valid business plans for research projects. This includes appropriate use of the research feasibility tool and cost analysis. §

Prepares and submits regulatory documents and supporting forms including appropriately modified consent forms to the Office of Research Integrity/Institutional Review Board. §

Initiates and maintains required clinical and regulatory files. §

Responds in a timely and accurate fashion to directives given by the IRB, ORI , FDA, US Department of Health and Human Services, District of Columbia Department of Health or the sponsor of the research study. §

Participates in conferences, departmental meetings, continuing education, investigator meetings, site initiation, interim monitoring and closeout study visits as assigned. §

Prepares and analyzes regular reports of research activity, including monthly billing forms, IRB continuation and closure requests, and patient enrollment logs. §

Prepares and submits accurate monthly billing sheets detailing expenses and reimbursements for milestones met as part of the research activity.

2. Clinical §

Communicates with sponsors, investigators, clinical monitors and colleagues to ensure effective clinical trial implementation and progress. §

Administers and/or dispenses investigation agents, under the auspices of the principal investigator or responsible clinician, as needed. §

Monitors each patient’s study progress to fulfill protocol and sponsor requirements. §

Completes required measures and milestone activities appropriate to the clinical course and monitoring of study subjects as required per protocol, including but not limited to: visits, laboratory tests, vital sign measurement, EKGs, health status assessment, adverse event monitoring and reporting, and investigational drug dispensing (if appropriate). §

Collaborates with PI and Coordinators to establish recruitment strategies, complying with regulations and guidelines. §

Develops patient screening and recruitment, study enrollment, and participant follow-up tools and plans.

3. Assists MCCRC staff and/or MRI investigators in study related activities, as assigned.

4. Seeks and avails self of opportunities to develop and advance knowledge base in clinical study areas.

5. 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 Research Institute policies and procedures; and c) reporting compliance concerns in an appropriate and timely manner.

6. Performs other duties as assigned

MedStar Health Research Institute is proud to be an Equal Opportunity Employer.

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