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The monitor and auditor will schedule and conduct various clinical trial site visits to ensure operational objectives are met and regulatory compliance is maintained. They will also review monitoring and audit reports to identify trends, resolve findings, and contribute to the development of study protocols and project materials.
Candidates must possess a Master’s degree in a life sciences discipline and at least eight years of relevant clinical research experience. A strong understanding of FDA regulations, ICH/GCP guidelines, and the ability to obtain a Federal public trust clearance are required.
Travel Required:
Clearance Required:
What You Will Do:
We are currently searching for a Clinical Trials Program Monitor and Auditor to independently provide support services to satisfy the overall operational and clinical trial objectives of the National Institute of Allergy and Infectious Diseases (NIAID). This is a full-time, on-site opportunity in Bethesda, MD.
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.
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
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 RecruitingAccommodation@guidehouse.com. 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 guidehouse@myworkday.com. Correspondence received by an applicant from any other domain should be considered unauthorized and will not be honored by Guidehouse. Note that Guidehouse will never charge a fee or require a money transfer at any stage of the recruitment process and does not collect fees from educational institutions for participation in a recruitment event. Never provide your banking information to a third party purporting to need that information to proceed in the hiring process.
If any person or organization demands money related to a job opportunity with Guidehouse, please report the matter to Guidehouse’s Ethics Hotline. If you want to check the validity of correspondence you have received, please contact recruiting@guidehouse.com. Guidehouse is not responsible for losses incurred (monetary or otherwise) from an applicant’s dealings with unauthorized third parties.
Guidehouse does not accept unsolicited resumes through or from search firms or staffing agencies. All unsolicited resumes will be considered the property of Guidehouse and Guidehouse will not be obligated to pay a placement fee.
Empowering our clients to meaningfully shape the future.
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.
Offices: 1676 International Dr, 800, McLean, Virginia 22102, US · 1800 Tysons Blvd, McLean, Virginia 22102, US · 1000 Wilson Blvd, Suite 1400, Arlington, Virginia 22209, US · 111 Congress Ave, Suite 2500, Austin, Texas 78701, US · 125 High St, Suite 401, Boston, Massachusetts 02110, US
