Clinical Trials Program Monitor and Auditor

This is a full-time, on-site opportunity in Bethesda, MD. Ability to obtain and maintain a Federal or DoD “public trust” is required; candidates must receive approved adjudication prior to onboarding. Candidates with an active public trust or suitability are preferred.

What You Will Do

• Schedule and conduct site visits, including site evaluation and qualification, initiation, interim, for-cause, pharmacy, and close-out monitoring visits.
• Develop and review clinical monitoring plans and audit plans for clinical trials.
• Review monitoring and audit reports for ongoing studies, resolve monitoring/audit findings by identifying necessary corrective actions and preventive measures; advise sites on the implementation of corrective actions and preventive measures.
• Review monitoring reports, audit reports, and performance metrics reports in aggregate to identify trends; propose recommendations to program leads to address those trends.
• Track monitoring and audit reports to ensure delivery within the required timeframe and ensure timely resolution of issues; communicate and coordinate with internal project staff and site staff.
• Review, coordinate, and contribute to protocol documents and required reports, including study protocols, consent forms, serious adverse event (SAE) reports, project and protocol deviation reports, accrual, and other study status or study website reports.
• Review and contribute to the development and/or modification of study and project materials, such as Manual of Procedures (MOPs), Clinical Monitoring Plans (CMPs), audit reports, and Standard Operating Procedures (SOPs).
• Contribute to the quality control review of protocol and consent documents.
• Participate in meetings with internal and external colleagues, and lead discussions related to monitoring and auditing.
• Coordinate and conduct training on monitoring/auditing best practices, trend analysis, and project required topics for site staff and internal and external colleagues.
• Review for accuracy and completeness adverse event files; prepare reports in accordance with Institutional Review Board (IRB) processes and policies.
• Develop and submit protocol actions for clearance within the NIH Protocol Tracking and Management System.
• Maintain documentation of clinical research training of staff.

Requirements

• Master’s degree in biology, life sciences or related discipline.
• Minimum eight (8) years of clinical research associate, clinical monitor, or similar experience.
• Expertise in the fundamentals of clinical trials, preferably in the areas of clinical data management, database operations and analysis.
• Familiarity with Institutional Review Board (IRB) requirements.
• Demonstrated understanding of FDA clinical research regulations and relevant ICH/GCP guidelines, especially those pertaining to clinical monitoring and auditing.

Skills

• Prioritization, problem-solving, organization, critical thinking, decision-making, time management, and planning activities.
• Self-motivated with high attention to detail.
• Interpersonal skills to collaborate effectively with internal and external colleagues and work in a team-oriented environment.
• Excellent verbal and written communication skills.
• Proficient in MS Office tools.

Pay

The annual salary range for this position is $130,000.00 - $216,000.00. Compensation decisions depend on a wide range of factors, including but not limited to skill sets, experience and training, security clearances, licensure and certifications, and other business and organizational needs.

Benefits

• Medical, Rx, Dental & Vision Insurance
• Personal and Family Sick Time & Company Paid Holidays
• Parental Leave
• 401(k) Retirement Plan
• Group Term Life and Travel Assistance
• Voluntary Life and AD&D Insurance
• Health Savings Account, Health Care & Dependent Care Flexible Spending Accounts
• Transit and Parking Commuter Benefits
• Short-Term & Long-Term Disability
• Tuition Reimbursement, Personal Development, Certifications & Learning Opportunities
• Employee Referral Program
• Corporate Sponsored Events & Community Outreach
• Care.com annual membership
• Employee Assistance Program
• Supplemental Benefits via Corestream (Critical Care, Hospital Indemnity, Accident Insurance, Legal Assistance and ID theft protection, etc.)

Position may be eligible for a discretionary variable incentive bonus.