Guidehouse
Overview
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. What You Will Do
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. Salary and Benefits
The annual salary range for this position is $130,000.00-$216,000.00. 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 1-571-633-1711 or via email at RecruitingAccommodation@guidehouse.com. All information you provide will be kept confidential and will be used only to the extent required to provide needed reasonable accommodation. Guidehouse is not responsible for losses incurred (monetary or otherwise) from an applicant’s dealings with unauthorized third parties. 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 recruiting@guidehouse.com. 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.
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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. What You Will Do
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. Salary and Benefits
The annual salary range for this position is $130,000.00-$216,000.00. 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 1-571-633-1711 or via email at RecruitingAccommodation@guidehouse.com. All information you provide will be kept confidential and will be used only to the extent required to provide needed reasonable accommodation. Guidehouse is not responsible for losses incurred (monetary or otherwise) from an applicant’s dealings with unauthorized third parties. 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 recruiting@guidehouse.com. 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