JOB SUMMARY:
The Metis Foundation is seeking a Clinical Research Coordinator II support the Military Cardiovascular Outcomes Research Program (MiCOR) at the Uniformed Services University (USU) in Bethesda, MD. This position will provide on-site support to MiCOR projects like the Genetic Exploration of Military Sudden Cardiac Arrest (GEMini) protocol, located at the Naval Medical Center (NMCSD) in San Diego, CA.
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.
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 DoW 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.
This position will have duties at the Naval Medical Center San Diego. The candidate may also be required to obtain a Secret Clearance and undergo credentialing prior to beginning work.
The CRC II will be responsible for providing support at NMCSD located in San Diego, CA. The Clinical Research Coordinator II (CRCII) will be responsible for assisting the Genetic Exploration of Military Sudden Cardiac Arrest (GEMini) protocol. GEMini is an observational, non-randomized study of the genetic contributions to Sudden Cardiac Arrest in the Military and their families. The Clinical Research Coordinator II will play a pivotal role in the planning, coordination, and execution of clinical research studies. This position requires an experienced and dedicated individual who can ensure the smooth conduct of clinical trials, maintain compliance with regulatory requirements, and support the research team in achieving project objectives. A minimum of 2 years of prior research and/ or medical experience is required. Previous experience in the areas of cardiovascular health outcomes, is preferred, but not required.
Key Responsibilities:
1. Clinical Trial Management: Coordinate and oversee all aspects of clinical research projects, including coordination of participant recruitment/ working with the recruiter, informed consent, study procedures, and data collection.
- Coordinate informed consent process according to GCP and MiCOR SOP guidelines.
- Coordinate various clinical activities (research participant schedules, data collection, and protocol test procedures)
- Adhere to study SOPs and protocols in order to perform study visits with research participants.
- Oversee the development and implementation of study recruitment plans.
- Work with medical staff on skilled procedures such as vital signs measurement, electrocardiograms, autonomic testing and phlebotomy.
- Oversee processing of human blood samples in accordance with research protocol and OSHA guidelines
- Oversee transport of human blood and saliva specimens in accordance with the research protocol and IATA guidelines.
- Oversee staff development of procedure manuals and case report forms for clinical research protocols.
- Visit off-site collaborative centers, as applicable.
2. Regulatory Compliance: Ensure strict adherence to relevant regulations, such as Good Clinical Practice (GCP) guidelines, and maintain necessary documentation for audits.
- Adheres to legal, professional and ethical codes with respect to confidentiality and privacy.
- Oversee ongoing protocol operations to ensure study compliance and troubleshoot possible protocol violations.
- Interface with Uniformed Services University or other relevant Institutional Review Board (IRB) to assist with coordination of revisions to the protocol regulatory requirements such as protocol amendments, reportable events, 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.
- Ensure proper and timely filing of standard clinical/regulatory documentation.
3. Patient Interaction: Effectively interact with study participants, ensuring the research project is being conducted according to GCP standards.
- Develop participant rapport, starting with the Informed Consent Process, and ensure the participant understands the protocol and study procedures.
4. Data Management: Collect, record, and manage data, maintaining the confidentiality and accuracy of research records.
- Document via established guidelines.
- Participate in quality improvement and quality assurance initiativesinvolving database and data system development efforts.
- Interact with auditing and monitoring agencies to facilitate the exchange of data.
5. Collaboration: Collaborate with cross-functional teams, including physicians, research scientists, and data analysts, to achieve research goals and meet participant medical, psychological and/or social needs.
- Interface with other protocol support personnel.
- Work with investigators and medical writers on the production/revision of clinical research protocols.
6. Training and Supervision: Train and supervise junior research staff, ensuring the proper conduct of research activities.
- Ensure that all required training is completed and documented according to protocol and GCP. Maintain protocol training files for all study team members.
7. Leadership Expectations: The Leadership Expectations allow leaders to work toward promoting a culture of mutual care and respect and striving to make the most meaningful and positive impact. Please see Appendix A. This is not an exhaustive list and the CRC II will be expected to perform other duties as needed.
Required Knowledge, Skills, and Abilities:
Preferred knowledge and skills: Experience in Cardiovascular clinical research; Understanding of clinical research regulatory affairs procedures.
Required knowledge and skills: Basic patient care principles and patient privacy/confidentiality. Knowledge of clinical research data collection and clinical data report preparation; Demonstrated expertise in data management; Excellent analytical, organizational and time management skills. Knowledge of Human Subjects Research and Good Clinical Practice (GCP). Knowledge of Microsoft Office Suite (MS Word, Excel, Outlook) and other spreadsheet applications. Strong communications skills, both oral and written. Ability to learn clinical research protocols and meet deadlines of projects.
Minimum Education/Training Requirements: Bachelor's degree (preferred in biology
or allied health).
Minimum Experience: at least 2 years in a clinical research or patient care environment preferred; educational equivalent may be considered. Experience in Cardiovascular or Neuroscience clinical research is highly preferred
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 Certification and CITI certification in GCP and Clinical Research Coordinator duties required and may be obtained upon hire. 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 Human Resources.
Pay: $60,000.00 - $70,000.00 per year
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Employee assistance program
- Flexible spending account
- Health insurance
- Health savings account
- Life insurance
- Paid time off
- Retirement plan
- Tuition reimbursement
- Vision insurance
Education:
Experience:
- clinical research regulatory: 1 year (Required)
- clinical research data collection : 1 year (Preferred)
- cardiovascular clinical research : 1 year (Required)
License/Certification:
- Certified Phlebotomy Technician (CPT) (Required)
Work Location: In person
