Job Family:Clinical Trial Operations
Travel Required:None
Clearance Required:Ability to Obtain Public Trust
What You Will Do:We are looking for a Senior Medical Officer to support the National Institute of Allergy and Infectious Diseases (NIAID), Division of Microbiology and Infectious Diseases (DMID), by providing clinical safety oversight, medical review, and clinical trial support services. This is a full-time position located in Rockville, MD.
- Assess serious adverse events (SAEs) from clinical trials.
- Assess SUSAR notifications from external organizations and evaluate potential impacts on active DMID studies.
- Perform periodic medical data reviews, including laboratory values, adverse events, coding documentation, tables, listings, and figures.
- Provide clinical safety oversight and review of DMID-sponsored clinical trial protocols.
- Review clinical trial protocols and provide recommendations related to safety and operational considerations.
- Review and provide recommendations regarding the design and safety of clinical trials.
- Represent DMID in communications with regulatory agencies, sponsors, and academic partners during clinical trial development and implementation.
- Serve as a medical and scientific subject matter expert for project teams.
- Collaborate with internal and external stakeholders to support program objectives.
- Review safety reports and serve as a DMID representative on safety committees.
- Participate in department meetings, training activities, and safety-related educational programs.
- Draft policies and guidelines related to clinical safety and study oversight.
- Provide advice and recommendations regarding clinical trial management.
- Identify process gaps and implementation challenges and participate in remediation efforts.
What You Will Need:- Medical degree from an accredited university.
- Minimum of SIX (6) years of medical, clinical research, pharmacovigilance, or clinical trial experience.
- Experience reviewing clinical trial protocols and safety documentation.
- Knowledge of adverse event and serious adverse event reporting requirements.
- Experience supporting clinical trial safety monitoring activities.
- Proficiency with Microsoft Office applications.
- 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:- Experience supporting infectious disease clinical trials.
- Prior experience interacting with FDA or other regulatory agencies.
- Previous service on clinical safety review boards or safety monitoring committees.
- Strong ability to communicate effectively and work collaboratively in a team environment.
- Experience developing clinical safety policies and guidance documents.
- Knowledge of Good Clinical Practice (GCP) and clinical research regulations.
The annual salary range for this position is $85,000.00-$141,000.00. 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
