Clinical Operations Manager

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 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 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. 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 View phone number on click.appcast.io or via email at View email address on click.appcast.io. 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 View email address on click.appcast.io. 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 View email address on click.appcast.io. 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. 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. #J-18808-Ljbffr Guidehouse