Clinical Research Coordinator
MedStar Health Research Institute - Washington, DC

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Position: Clinical Research Coordinator

Department: Medstar Cardiovascular Research Network

Status: Exempt

Supervised By: Director, Cardiovascular Research Programs

Position(s)
Supervised : NA

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Summary

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 MCRN staff
and/or MHRI 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. Carry pager and respond to
pages on off-hours & weekends for patient screening and clinical
troubleshooting purposes.

12. May be required to work
off-hours & weekends for study-related activities.

list0ptbr: 32.25pt" 13.
Train
new clinical research staff on the basics of clinical trials, basic clinical
data analysis and serve as a resource when needed

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Assist
in the supervision and assessment of Junior Research Staff during probationary
evaluation.

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Perform
other duties as assigned

Minimum Qualifications:
Education:
RN with licensure or eligibility for licensure in the District of Columbia

MedStar Health Research Institute - 17 months ago - save job - block
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