Job Family:Clinical Trial Operations
Travel Required:None
Clearance Required:Ability to Obtain Public Trust
What You Will Do:We are looking for a Clinical Operations Manager to support the National Institute of Allergy and Infectious Diseases (NIAID) by providing operational, administrative, and clinical study support for the Division of Microbiology and Infectious Diseases (DMID). This position is a full-time position located in Rockville, MD.
- Coordinate with Respiratory Diseases Branch (RDB) and Enteric and Sexually Transmitted Infections Brach (ESTIB) staff to develop standardized procedures for organizing clinical study and clinical trial logistical functions in accordance with Division of Microbiology and Infectious Diseases (DMID) procedures.
- Assist RDB/ESTIB staff with the development, collection, and quality review of essential clinical study documents and enter documentation into DMID databases.
- Track the development of monitoring plans and the status of data and safety reviewers.
- Meet regularly with program staff to provide updates on ongoing projects and receive new assignments.
- Assist with special projects requiring immediate action and support emerging program priorities.
- Plan and coordinate meetings with program staff and external stakeholders as requested.
- Take meeting notes and prepare meeting minutes for program staff and other attendees.
- Assist with clinical project management activities supporting ESTIB.
- Inventory, review, organize, and file low-resource tier clinical study documentation.
- Work with funded investigators to ensure required clinical documents are received in accordance with DMID policies.
- Coordinate 10-day pre-Council application reviews and ensure appropriate assignment of applications.
- Ensure gender and minority coding for clinical research projects is submitted and entered into applicable databases in a timely manner.
- Serve as the point of contact, or support the point of contact, for agreements including Non-Clinical Evaluation Agreements (NCEAs), Material Transfer Agreements (MTAs), and Clinical Trial Agreements (CTAs).
- Assist with maintaining the Medical Information System (MIS) database, including content reviews, service request uploads, study result updates, and coordination with requestors.
- Create and/or assist with management of RDB and ESTIB SharePoint sites
What You Will Need:- Bachelor's degree in Business Management and Administration or a related discipline, or an equivalent combination of education and experience.
- Minimum of TWO (2) years of experience in clinical support and/or operations.
- Experience supporting program management and protocol management activities.
- Experience with budget tracking and monitoring activities.
- Proficiency with Microsoft Office applications.
- Experience using and administering SharePoint sites.
- 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 NIH, HHS, or other Federal health research programs.
- Experience coordinating clinical studies, clinical trials, or research administration programs.
- Strong organizational, document management, and coordination skills.
- Strong written and verbal communication skills, including meeting coordination and minutes preparation.
- Familiarity with DMID clinical research processes and procedures.
- Experience managing research-related databases and tracking systems.
- Experience supporting agreement administration, including NCEAs, MTAs, and CTAs.
- Advanced SharePoint administration and collaboration site management experience.
The annual salary range for this position is $65,000.00-$108,000.00. 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
