Tenacity Solutions

Tenacity Solutions, LLC (Tenacity) is seeking an experienced Clinical Research Quality Associate (CRQA) to support the Department of Veterans Affairs (VA) Cooperative Studies Program (CSP) Site Monitoring, Auditing and Resource Team (SMART). The CRQA will perform Good Clinical Practice (GCP) monitoring of multi-site clinical research studies conducted at VA medical centers and affiliated research sites throughout the United States. Employment under this position is contingent upon Tenacity Solutions' successful award of the contract.

Duties:

This position requires an experienced clinical research professional with extensive knowledge of ICH-GCP guidelines, FDA regulations, federal research requirements, and clinical trial monitoring. The successful candidate will conduct on-site and remote monitoring visits, assess protocol compliance, review informed consent and regulatory documentation, verify source data, identify compliance issues, support corrective and preventive actions (CAPAs), and prepare comprehensive monitoring reports.

Note: Employment under this position is contingent upon Tenacity Solutions' successful award of the contract.

Key Responsibilities Include:

• Conduct site initiation, routine monitoring, and closeout visits for federally funded clinical research studies.
• Perform on-site and remote monitoring activities in accordance with study-specific monitoring plans.
• Review protocol compliance, informed consent documentation, eligibility criteria, source documentation, investigational product accountability, adverse events, and regulatory files.
• Verify Case Report Forms (CRFs) against source documentation.
• Evaluate investigator sites for compliance with ICH-GCP, FDA regulations, VA policies, and study protocols.
• Identify compliance issues and communicate significant findings to project leadership.
• Assist research sites with development and implementation of Corrective and Preventive Actions (CAPAs).
• Prepare detailed monitoring reports, investigator summary letters, and supporting documentation within required timelines.
• Participate in study kickoff meetings, investigator meetings, and required training.
• Support development of monitoring tools, quality documents, and other Program Quality Support activities.
• Maintain confidentiality of Protected Health Information (PHI) and comply with all VA privacy and information security requirements.
• Collaborate effectively with investigators, study coordinators, sponsors, and Government representatives.

Minimum Qualifications:

• Bachelor's degree in a scientific, health-related, or clinical field, or professional healthcare licensure (RN, PharmD, PA, NP, MD, DO, etc.), or equivalent Clinical Research Associate certification.
• Minimum 10 years of Good Clinical Practice (GCP) clinical trial monitoring experience.
• Minimum 5 years of monitoring or auditing federally funded clinical research studies (VA, NIH, DoD, CDC, or other federal agencies).
• Strong knowledge of:
• ICH E6 Good Clinical Practice
• FDA clinical trial regulations
• Human Subjects Protection requirements
• Clinical trial documentation
• Source data verification
• CAPA development
• Risk-based monitoring
• Experience monitoring multi-site clinical trials.
• Experience reviewing electronic medical records and clinical documentation.
• Proficiency with Microsoft Office Suite, SharePoint, Adobe Acrobat, and electronic clinical trial systems.
• Excellent written and verbal communication skills.
• Ability to travel extensively throughout the United States.

Preferred Qualifications:

• Certified Clinical Research Associate (CCRA) through ACRP or equivalent certification.
• Previous VA Cooperative Studies Program (CSP) experience.
• Experience serving as a Lead CRA or Sponsor's Designated Representative (SDR).
• Clinical trial auditing experience.
• Experience supporting NIH, VA, or other federally sponsored clinical research programs.

Clearance & Other Requirements:

• Ability to successfully complete a VA background investigation.
• Ability to obtain required VA system access and complete mandatory VA privacy, security, and research training.
• Ability to travel approximately 40–60% based on study assignments.

Tenacity Solutions, LLC (Tenacity) is a Service-Disabled Veteran Owned Small Business (SDVOSB) founded by our CEO, Gabriel Brown, CAPT, USN (Ret). Tenacity is an innovative company, leveraging talent, skill, and knowledge with cutting-edge and proven practices to deliver solutions and products that exceed customers’ requirements and surpasses their expectations. Tenacity immediately has become a leading technology and management solutions provider with a mission to advance healthcare services for specialized populations including Veterans and their families. Headquartered in North, Bethesda, Maryland (DMV), our talented resources are located across the United States. We bring diverse talent to design solutions that help customers with their greatest challenges.