Clinical Research Coordinator
Company: The Metis Foundation
Posted on: November 26, 2022
The Metis Foundation is seeking a *Clinical Research
Coordinator* to support a protocol in collaboration with two
research programs at the Uniformed Services University of the
Health (USU) Sciences in Bethesda, MD: the Military Cardiovascular
Outcomes Research program (MiCOR) and the Translational Medicine
MiCOR is a program intended to understand the impact of military
service- particularly precision medicine, stress, weight gain,
exercise, and pharmacotherapy- on cardiovascular risk. The mission
of the MiCOR Program is to enhance the cardiovascular health and
well-being of the Warfighter and the DOD community through
innovative clinical research using precision techniques. MiCOR has
a variety of clinical research studies focused on both the
biomedical and behavioral components that contribute to
cardiovascular risk and disease. MiCOR is working in collaboration
with the TMU for this exciting study.
The TMU was founded in the late 1980's as the Clinical Pharmacology
Unit by Dr. Louis Cantilena, MD, PhD. It is a storied unit with
major contributions to medical product development and scientific
literature. TMU currently conducts more than a dozen clinical
research studies and aims to conduct 2-4 clinical trials a year of
novel products to benefit military medicine and to protect and
treat warfighters engaged in Multi-Domain Operating
This position will potentially have duties at Walter Reed National
Military Medical Center and the candidate may be required to obtain
a Secret Clearance as well as undergo Credentialing before
Clinical Research Coordinator (CRC) will be the primary coordinator
for the COVIVA project which is a Comparative cohort study of
post-acute COVID-19 infection with a nested, randomized control
trial of Ivabradine for those with postural orthostatic tachycardia
syndrome. Participants will be followed for one year in both the
cohort and the RCT portion of the study. Responsibilities for the
CRC include performing clinical research and participant care in
conjunction with a specified clinical research protocol. The
position requires an individual who is highly responsible and who
has excellent communication and organizational skills. Prior
research and/ or medical experience, especially in the areas of
cardiovascular health outcomes, is preferred, but not required.
The Metis Foundation is a 501c (3) specifically organized to
advance clinically relevant scientific research to the medical
community, especially within the US Department of Defense. We
provide scientific, educational, financial and project management
support in the conduct of federally and industry-sponsored
research, clinical trials and education. The Metis Foundation
provides scientific, technical and programmatic support services to
MiCOR, TMU and USU.
*ESSENTIAL JOB DUTIES: *
* Adheres to legal, professional and ethical codes with respect to
confidentiality and privacy.
* Collaborate in the recruitment of research participants. Screen
and enroll research participants.
* Develop participant rapport and work with staff on explaining
protocol and tests/procedures.
* Adhere to study SOPs and protocols in order to perform study
visits with research participants.
* Consult with health care professionals regarding medical,
psychological and/or social patient needs.
* Document via established guidelines.
* Track and revise protocol regulatory requirements such as
coordinating protocol amendments, writing informed consent forms/
HIPAA forms, writing annual reports and IRB renewals, revising
protocol language as needed, and address stipulations issued from
IRB team to reach approval, while keeping investigators apprised of
* Coordinate various activities (research participant schedules,
data collection, and protocol test procedures) to ensure proper and
timely filing of standard clinical/regulatory documentation,
serious adverse events, amendments, annual reports and other
* Work with medical staff on skilled procedures such as autonomic
testing and phlebotomy.
* Work with staff to develop procedure manuals for clinical
* Work with staff to create case report forms.
* Visit off-site collaborative centers, as applicable.
* Oversee ongoing protocol operations to ensure study compliance;
troubleshoot possible protocol violations.
* Interface with Uniformed Services University or other relevant
Institutional Review Board (IRB); coordinate filing of
unanticipated events, adverse events, amendments, continuing review
applications, annual reports, protocol inactivation and other
* Manage research participant files; copy and organize research
* Maintain study records, master files, equipment, and
* Collaborate with PIs to interpret research data for protocol
* Work with investigators and medical writers on the
production/revision of clinical research protocols.
* Support the needs of data integrity and retrieval.
* Participate in quality improvement and quality assurance
initiatives involving database and data system development
* Work with staff to identify the responsible party for data input
into ClinicalTrials.gov at study conclusion, as applicable.
* Participate in efforts to ensure scientific quality and human
* Interact with auditing and monitoring agencies to facilitate the
exchange of data.
* Interface with other protocol support personnel.
* Performs other duties as needed.
_Upon request, the contractor shall provide documentation evidence
of any and/or all work product, including, but not limited to, the
following tasks: _
* Work products and documents related to providing clinical care
for outpatient clinical programs; document patient care via
* Work products and documents related to coordinating research
participant schedules, data/bio specimen collection and participant
care; work with medical staff on skilled procedures; order
protocol-mandated tests, labs and procedures; improve processes and
services to participants, family members and colleagues.
* Work products and documents related to recruiting, screening and
enrolling participants; follow participants between visits;
collaborate with community physicians; serve as liaison among sites
* Work products and documents related to clinical research protocol
development, develop procedure manuals; create case report forms;
visit off-site collaborative centers; ensure protocol compliance;
troubleshoot possible protocol violations.
* Work products and documents related to interfacing with IRB and
other regulatory bodies; coordinate filing of documents; conduct
staff updates; collaborate with PIs to interpret research data for
*Required Knowledge, Skills, and Abilities: * Experience in
Cardiovascular clinical research is highly preferred. Knowledge of
clinical research data collection and clinical data report
preparation. Basic patient care principles and patient
privacy/confidentiality are required. Understanding of clinical
research regulatory affairs procedures preferred. Demonstrated
expertise in data management. Knowledge of Microsoft Office Suite
(MS Word, Excel, Outlook) and other spreadsheet applications.
Strong communications skills, both oral and written. Excellent
analytical, organizational and time management skills. Knowledge of
Human Subjects Research and Good Clinical Practice (GCP) is highly
recommended; ability to learn clinical research protocols, meet
deadlines of projects..
*Minimum Education/Training Requirements: * Bachelor's degree
(preferred in nursing or allied health).
*Minimum Experience: * at least 2 years in a clinical research
*Physical Capabilities: * Long periods of sitting, standing,
escorting participants, carrying light items; may encounter
participants who are confused, agitated, or abusive
*Required Licenses, Certification or Registration: *CPR/BLS
Certified preferred and able to obtain CITI certification in GCP
and research coordinator duties. Must also be able to obtain a
government issued common access card.
*Work Environment: * Office and clinical patient care area;
possible evening and/or weekend hours.
*Metis Foundation is an equal opportunity and affirmative action
employer. All qualified applicants will receive consideration for
employment without regard to race, color, religion, sex, sexual
orientation, gender identity, national origin, disability, or
protected veteran status.*
_Any qualifications to be considered as equivalents, in lieu of
stated minimums, require the prior approval of the Director of
Job Types: Full-time, Contract
Pay: $40,000.00 - $60,000.00 per year
* 401(k) matching
* Dental insurance
* Employee assistance program
* Health insurance
* Life insurance
* Paid time off
* Parental leave
* Vision insurance
* Evening shift
* Monday to Friday
* Weekend availability
Ability to commute/relocate:
* Bethesda, MD: Reliably commute or planning to relocate before
starting work (Required)
* Bachelor's (Required)
* Clinical research: 2 years (Required)
Work Location: One location%58047475%
Keywords: The Metis Foundation, Bethesda , Clinical Research Coordinator, Healthcare , Bethesda, Maryland
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