Regulatory and Clinical Trials Manager
GuidehouseAbout the role
Job Family:
Clinical Trial Operations (Digital)
Travel Required:
Clearance Required:
What You Will Do:
We are currently searching for a Regulatory and Clinical Trials Manager. This role will perform scientific and technical services in support of research by the Division of Intramural Research, in the National Heart Lung and Blood Institute (NHLBI) in cardiovascular intervention. This is a full-time opportunity supporting the NHLBI office located in Bethesda, MD.
Lead protocol navigation and manage a portfolio of clinical trials for the Cardiovascular Intervention Program at NHLBI.
Collaborate with investigators and study teams to develop and revise protocols and informed consent forms.
Coordinate regulatory submissions including IDE applications, amendments, safety reports, and FDA annual reports.
Facilitate regulatory approvals and ensure compliance with NIH and FDA guidelines.
Support study teams in navigating IRB, radiation safety, and other review processes.
Maintain regulatory documentation, track approvals, and manage protocol lifecycle activities.
Liaise with internal and external stakeholders to establish CTAs, MTAs, and Certificates of Confidentiality.
Provide regulatory guidance, SOP development, and training on GCP and human subjects protection.
Prepare for and support FDA audits; ensure complete and organized sponsor/investigator records.
Stay current on regulatory developments and recommend strategies for timely approvals.
What You Will Need:
Bachelor’s in nursing (BSN)
A minimum of EIGHT (8) years of experience in cardiology research, biomedical research, clinical trials, and/or related research experience.
In-depth knowledge of clinical trial operations, including protocol development, project management, regulatory compliance, data requirements, and ICH/GCP guidelines.
Expert understanding of federal laws, FDA regulations, and NIH policies governing clinical research, enabling effective planning, implementation, and compliance oversight.
Demonstrated analytical thinking and problem-solving abilities, with a dynamic and evolving knowledge base that supports high-level decision-making and research methodology.
What Would Be Nice To Have:
Previous experience with NIH preferred.
Strong communication skills, both written and verbal, with the ability to convey complex regulatory concepts to technical and non-technical audiences.
Proven ability to work independently while building strong, collaborative relationships across multidisciplinary teams.
Prior experience as a nurse, nurse practitioner or technologist in interventional cardiology or cardiovascular surgery or structural heart disease program coordination is preferred but not required.
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 Vetera
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