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 NIAID/DMID by providing expert guidance on clinical trial oversight, Institutional Review Board (IRB) processes, pediatric clinical care considerations, and clinical safety management. This is a full-time position located in Rockville, MD.
- Provide advice and recommendations regarding Institutional Review Board (IRB) processes, pediatric clinical care, hospital pharmacy operations, and related healthcare communities.
- Provide expert guidance on the oversight of clinical trials.
- Review clinical trial protocols.
- Review and comment on safety and operational issues associated with DMID-sponsored protocols.
- Assess serious adverse events arising from clinical trials.
- Review and provide recommendations regarding the design and safety of clinical trials.
- Represent DMID in communications with FDA representatives, sponsors, and academic collaborators regarding clinical trial design and implementation.
- Review safety reports and serve as a safety expert on committees.
- Participate in standing department meetings, training, and educational activities.
- Draft policies and guidelines affecting participants enrolled in DMID-sponsored studies.
What You Will Need:- Medical degree from an accredited university.
- Minimum of SIX (6) years of medical, pediatric, clinical research, or clinical trial oversight experience.
- Experience supporting IRB review processes and clinical study oversight.
- Experience reviewing clinical trial protocols and safety reports.
- Knowledge of clinical trial safety monitoring and regulatory compliance.
- Proficiency with Microsoft Office applications.
- Superior medical writing skills.
- 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 pediatric clinical research programs.
- Familiarity with hospital pharmacy operations and medication safety programs.
- Experience drafting medical policies, procedures, and regulatory guidance.
- Experience participating on safety review committees.
- Knowledge of FDA regulations and Good Clinical Practice (GCP).
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
