Clinical Research Coordinator II

The Metis Foundation is seeking a Clinical Research Coordinator II (CRC II) to support the Military Cardiovascular Outcomes Research Program (MiCOR) at the Madigan Army Medical Center (MAMC) located on Joint Base Lewis-McChord, WA. The CRC II will support the Respiratory Threat Real-time Assessment and Control (R-TRAC) study and other MiCOR projects.

The Metis Foundation is a 501(c)(3) specifically organized to advance clinically relevant scientific research to the medical community, especially within the Department of War (DoW). The Metis Foundation provides 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 Uniformed Services University (USU).

MiCOR, headquartered at USU in Bethesda, MD, 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 relevant Military Treatment Facility (MTF) (e.g. MAMC, Wilford Hall Ambulatory Surgical Center, Walter Reed National Military Medical Center, etc.) and on some occasions may be required to travel within the continental United States in support of these MTFs. 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 on-site support at MAMC located in Joint Base Lewis-McChord, WA. The CRC II will play a pivotal role in the planning, coordination, and execution of tasks in support of MiCOR research efforts, including the R-TRAC protocol, as well as other cardiovascular-focused research activities. The overall purpose of this study is to conduct, in collaboration with multiple Defense Health Agency sites and external collaborators, the development of a biosensor that will eventually be capable of integrating into a system comprising biosensors, respiratory risk assessment software, and healthy building controls to mitigate bioaerosol-related respiratory illnesses in military healthcare facilities. The CRC II will support the R-TRAC research team by ensuring the smooth execution of local research activities, including sample collection and shipment, and maintaining local compliance of regulatory requirements in order to achieve established project objectives. In addition to the R-TRAC protocol, the CRC II will provide equivalent support for cardiovascular research activities and may also assist with other multidisciplinary and cross-departmental research protocols, as needed, to meet programmatic and operational priorities. A minimum of 2 years of prior research and/or medical experience is preferred. Previous experience in clinical research, cardiovascular health outcomes, or military health research is highly preferred but not required.

Key Responsibilities:

1. Clinical Research or Clinical Trial Coordination and Execution: 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 and obtain informed consent process according to GCP and MiCOR SOP guidelines.
• Coordinate and perform various clinical activities (research participant schedules, sample collection and shipping, data collection, and protocol test procedures)
• Adhere to study SOPs and protocols in order to perform study visits with research participants.
• Collaborate with relevant team members in the development and implementation of study recruitment plans.
• Complete skilled procedures such as vital signs measurement, electrocardiograms, autonomic testing and phlebotomy in conjunction with appropriate medical staff.
• Perform processing of human biological samples in accordance with research protocol and OSHA guidelines in collaboration with other team members
• Work with relevant team members to ensure proper transport of human biological specimens in accordance with the research protocol and IATA guidelines.
• Collaborate with relevant team members to develop 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 federal and DoW regulations, such as GCP guidelines, and maintain necessary documentation for audits.

• Adheres to legal, professional, and ethical codes with respect to confidentiality and privacy.
• Adheres to federal and DoW data governance regulations and maintains compliance of data usage, sharing, and transferring policies as indicated by study-specific Data Usage Agreements and/or Data Sharing Agreements.
• Engage in protocol operations to maintain study compliance and work with relevant team members to address possible protocol deviations/violations.
• Assist relevant team members with the coordination of regulatory requirements such as protocol amendments, reportable events, writing informed consent forms and HIPAA forms, writing annual reports and IRB continuing reviews, and address stipulations issued from IRB to reach approval, while keeping investigators apprised of changes.
• Ensure proper and timely filing of standard clinical/regulatory documentation in collaboration with relevant team members.

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 initiatives involving 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 health, 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. Support maintenance of 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.

Note: 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 clinical research, preferably in cardiovascular, infectious diseases, or military health 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 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. Research relevant certification preferred with experience in cardiovascular, infectious diseases, and/or military medical clinical research is highly preferred.

Physical Capabilities: Frequent standing/walking, lifting 20lbs, ability to manage data entry (sitting/standing) with participant interaction. Strong communication and deescalation skills are imperative when encountering participants who are confused, agitated, or abusive.

Required Licenses, Certification or Registration: Active CPR or BLS Certifications are preferred, but may also be obtained throughout the employment based on study needs. CITI certifications in Biomedical Investigators, GCP FDA option, Responsible Conduct of Research, and Clinical Research Coordinator duties are required based on study and role, and may be obtained upon hire. Must also be able to obtain a government issued common access card (CAC).

Work Environment: Office and clinical patient care area; possible evening and/or weekend hours. This position has frequent interaction with medical professionals (Nurses, Physicians, Techs, healthcare administrators etc.).

Transportation Requirements: Ability totransport and ship samples to a mail carrier and offsite locations.

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.