Clinical Research Coordinator

The Metis Foundation is seeking a motivated and detail-oriented Clinical Research Coordinator to support the Quality Skin Collaborative for Advanced Skin Regeneration/Reconstruction (QSCARR) program at the U.S. Army Institute of Surgical Research (USAISR). Under the supervision of the QSCARR Program Manager, the Clinical Research Coordinator will contribute to translational human research efforts with a focus on military-relevant regenerative medicine, wound healing, and combat casualty care, demonstrating a strong ability to operate autonomously.

This position offers a unique opportunity to be embedded in a military research environment, supporting projects that directly impact service members and advance innovations in trauma and surgical care.

Key Responsibilities

• Clinical Trial Management: Independently execute all phases of clinical research projects, including participant recruitment, informed consent (according to GCP and applicable SOPs), scheduling study procedures, and data collection. Oversee the processing and transport of human biological samples (blood and saliva) following OSHA and IATA guidelines, and assist medical staff with procedures like vital signs and phlebotomy.
• Regulatory Compliance: Ensure strict adherence to Good Clinical Practice (GCP) and all relevant regulations, maintaining all necessary documentation for audits. Serve as liaison with the Institutional Review Board (IRB) for protocol submissions, amendments, reportable events, annual reviews, and addressing all regulatory stipulations to secure and maintain approvals. Ensure proper and timely filing of all clinical/regulatory documentation while adhering to confidentiality codes.
• Professional and Ethical Conduct: Maintain the highest standards of professional conduct, ethics, and integrity in all research activities. Strictly adhere to The Metis Foundation's Employee Handbook and Confidentiality Agreement. Ensure compliance with HIPAA and all ethical codes regarding participant privacy, data security, and the handling of Protected Health Information (PHI).
• Patient Interaction: Manage effective interaction with study participants according to GCP standards, ensuring robust rapport and comprehensive understanding of the protocol through the Informed Consent Process.
• Data Management: Collect, record, and manage accurate and confidential research data. Participate in quality improvement initiatives, including database development, and facilitate data exchange with auditing and monitoring agencies.
• Collaboration: Collaborate with multidisciplinary teams (physicians, scientists, analysts) to meet research objectives and address participant needs. Assist in the production and revision of clinical research protocols.

Minimum Qualifications

• Bachelor’s degree in a scientific or health-related field and a minimum of one year of direct, hands-on experience in clinical research coordination, including the preparation of documents for IRB/Regulatory submission.
• Ability to work in a clinical environment.
• Strong written and verbal communication skills with an emphasis on accuracy and professionalism.
• Proven capability to work autonomously, manage multiple research priorities efficiently, and troubleshoot issues independently.
• Proficient with Microsoft Office (Word, Excel, PowerPoint); familiarity with research data systems (e.g., REDCap) is preferred

Preferred Qualifications

• Previous experience in clinical research or regulatory affairs, preferably in military or academic settings.
• Familiarity with Good Clinical Practice (GCP) principles.
• Understanding of regulatory frameworks (e.g., IRB, FDA, HIPAA).
• Knowledge of or interest in combat casualty care, regenerative medicine, or trauma research is highly desirable.
• Bilingual proficiency in Spanish (written and verbal) is highly desirable.

Work Conditions

• Location: USAISR, Fort Sam Houston, TX
• May involve exposure to biological samples, chemicals, and use of PPE in various settings.
• May require standing for long periods, lifting supplies, or working evenings/weekends based on protocol needs.
• Some travel may be required for training or collaboration with partner sites.

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.