Clinical Trials Program Monitor and Auditor

Dovel Technologies, Inc; Bethesda (MD); Hybrid; USD 130,000 - 216,000; Full time

Benefits offered by this job

Medical Insurance

401(k) Retirement Plan

Paid Holidays

Tuition Reimbursement

Job summary

Guidehouse is seeking an experienced Clinical Trial Operations professional to schedule site visits, develop monitoring plans, and review trial documentation across multiple studies. You will identify corrective actions, coordinate with internal and site staff, and ensure timely issue resolution in line with IRB and FDA guidelines.

The role requires a Master’s degree in biology or life sciences and 8+ years of related experience, with ability to obtain public trust.

Qualifications

• Master’s degree in biology, life sciences or related discipline.
• Minimum 8 years of clinical research associate or monitor experience.
• Familiarity with FDA regulations and ICH/GCP guidelines.
• Ability to obtain/maintain federal public trust; onboarding requires adjudication.

Responsibilities

• Schedule and conduct site visits (evaluation, initiation, interim, for-cause, pharmacy, close-out).
• Develop and review clinical monitoring and audit plans for trials.
• Review reports and findings; propose corrective actions and preventive measures.
• Coordinate actions to meet timelines; communicate with project staff and sites.
• Review protocol documents, consent forms, SAE reports, and study status reports.
• Contribute to SOPs, CMPs, and MOPs; ensure quality control of protocols and documents.
• Lead discussions in meetings and provide training on monitoring best practices.
• Review adverse event files for accuracy; prepare reports per IRB processes.

Skills

Clinical monitoring

FDA regulations

IRB familiarity

Team leadership

MS Office

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.
• 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.

What We Offer

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.

• 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.

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