The Metis Foundation is seeking a Senior Research Associate to support the Military Cardiovascular Outcomes Research program (MiCOR), a program intended to understand the impact of military service- particularly precision medicine, stress, weight-gain, exercise, and pharmacotherapy- on cardiovascular risk at the Uniformed Services University of the Health (USU) Sciences in Bethesda, MD.
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 and USU.
Responsibilities are to perform clinical research and patient care in conjunction with a specified clinical research protocol. The position requires an individual who is highly responsible and who has excellent organizational skills. Prior research experience, especially in the areas of psychology, genomics and/or cardiovascular health outcomes preferred, but not required.
ESSENTIAL JOB DUTIES: 95% of time
· Adheres to legal, professional and ethical codes with respect to confidentiality and privacy.
· Recruit and enroll research subjects.
· Develop participant rapport and work with staff on explaining protocol and tests/procedures.
· Provide clinical care if and when needed during subject visits.
· Consult with health care professionals regarding medical, psychological and/or social patient needs.
· Document patient care 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 changes.
· Coordinate various activities (research subject 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 regulatory documents.
· Work with medical staff on skilled procedures such as autonomic testing and phlebotomy.
· Work with staff to develop procedure manuals for clinical research protocols.
· 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 regulatory documents.
· Work with staff on the management of research subject files; copy and organize research data.
· Maintain study records, master files, equipment, and supplies.
· Collaborate with PIs to interpret research data for protocol team.
· 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 efforts.
· 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 subjects’ protection.
· 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 established guidelines.
· Work products and documents related to coordinating research subject schedules, da- ta/biospecimen collection and patient care; work with medical staff on skilled procedures; order protocol-mandated tests, labs and procedures; improve processes and services to patients, family members and colleagues.
· Work products and documents related to recruiting, screening and enrolling subjects; follow subjects 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 protocol team.
Required Knowledge, Skills, and Abilities: Experience in Cardiovascular or Neuroscience 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; strong communication and organization skills.
Minimum Education/Training Requirements: Bachelor's degree (preferred in nursing or allied health).
Minimum Experience: at least 2 years in a clinical research environment.
Physical Capabilities: Long periods of sitting, standing, escorting patients, carrying light items; may encounter patients who are confused, agitated, or abusive
Required Licenses, Certification or Registration: Must be CPR/BLS Certified and able to obtain CITI certification in GCP and research coordinator duties.
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 Human Resources.