Clinical Trials Program Monitor and Auditor

US132 Guidehouse Digital, LLC; Bethesda (MD); On-site; USD 130,000 - 216,000; Full time

Benefits offered by this job

Medical Insurance

401(k)

Parental Leave

Travel Assistance

Job summary

Guidehouse in Bethesda, MD is seeking an experienced Clinical Trial Operations professional to oversee site monitoring visits, reviews, and audit activities for multiple studies.

The role requires strong expertise in FDA/ICH guidelines, IRB processes, and the ability to obtain and maintain a Federal or DoD public trust. You will develop monitoring plans, train staff, and drive quality across projects.

Qualifications

• Master’s degree in biology, life sciences or related discipline.
• Minimum 8 years of clinical research associate or similar experience.
• Familiar with IRB requirements and FDA/ICH/GCP guidelines for monitoring and auditing.
• Must be able to obtain and maintain a Federal or DoD public trust.

Responsibilities

• Schedule and conduct site visits including site evaluation, initiation, interim, for-cause and close-out monitoring visits.
• Develop and review clinical monitoring plans and audit plans for clinical trials.
• Review monitoring and audit reports and manage corrective actions and preventive measures.
• Track monitoring and audit reports to ensure timely delivery and coordinate with staff.
• Review and contribute to protocol documents and required reports, including SOPs and CMPs.
• Coordinate and conduct training on monitoring/auditing best practices for site staff and colleagues.
• Maintain documentation of clinical research training of staff.

Skills

FDA/ICH/GCP knowledge

IRB familiarity

Public trust eligibility

Monitoring & auditing expertise

Education

Master’s degree in biology, life sciences or related discipline

Tools

MS Office

Job description

Job Family: Clinical Trial Operations Travel Required: None Clearance Required: Ability to Obtain Public Trust

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.

What You Will Need:

• 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, and Must be familiar 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.
• Must be able to obtain and maintain a Federal or DoD “public trust”; candidates must receive approved adjudication prior to onboarding with Guidehouse.
• Candidates with an active public trust or suitability are preferred.

What Would Be Nice To Have:

• Possess skills in the following areas prioritization, problem-solving, organization, critical thinking, decision-making, time management, and planning activities.
• Self-motivated with high attention to detail.
• Utilize 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.

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.

What We Offer:

Guidehouse offers a comprehensive, total rewards package that includes competitive compensation and a flexible benefits package that reflects our commitment to creating a diverse and supportive workplace. Benefits include: 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

About Guidehouse

Guidehouse is an Equal Opportunity Employer–Protected Veterans, Individuals with Disabilities or any other basis protected by law, ordinance, or regulation. Guidehouse will consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of applicable law or ordinance including the Fair Chance Ordinance of Los Angeles and San Francisco. If you have visited our website for information about employment opportunities, or to apply for a position, and you require an accommodation, please contact Guidehouse Recruiting at 1-571-633-1711 or via email at [e-mail]. All information you provide will be kept confidential and will be used only to the extent required to provide needed reasonable accommodation. All communication regarding recruitment for a Guidehouse position will be sent from Guidehouse email domains including @guidehouse.com or [e-mail]. Correspondence received by an applicant from any other domain should be considered unauthorized and will not be honored by Guidehouse.

Guidehouse is a global AI-led professional services firm delivering advisory, technology, and managed services to the commercial and government sectors. With an integrated business technology approach, Guidehouse drives efficiency and resilience in the healthcare, financial services, energy, infrastructure, and national security markets. Built to help clients across industries outwit complexity, the firm brings together approximately 18,000 professionals to achieve lasting impact and shape a meaningful future. guidehouse.com