Clinical Trials Regulatory and Compliance Director (NIH)

Job title: Clinical Trials Regulatory and Compliance Director (NIH) Company: Ripple Effect Job description: Do you have interest in national level clinical research regulatory processes? Are you interested in playing an instrumental role in overseeing administrative, regulatory, and statistical support for clinical research management for NIH? Ripple Effect is looking for a Clinical Trials Regulatory and Compliance Director with 15 years of experience to support our client’s mission. This role will work closely with the and will independently provide guidance services to satisfy the overall operational objectives of the NIA. The primary objective is to provide regulatory and analytical oversight by ensuring high-quality clinical research operations and team quality assurance expertise. Oversight will include managing NIA scientific clinical resources, supporting documentation and quality assurance procedures, conducting risk assessments, and tracking regulatory compliance, Institutional Review Board (IRB) approval, and NIA clinical risk management updates. If this position sounds of interest, there’s a place for you here at Ripple Effect! We are a diverse, progressive, and engaging work environment. We offer a multitude of incentives and flexible work options that work for you and your lifestyle. General Information • Job Code: SHR-RA-06M • Location: NIH Main Campuses • Employee Type: Exempt, Full-Time Regular • Telework: Partial • Clearance: Public Trust • Manager: Yes • Number of Openings: 1 • Salary Range: $134,500 to $154,500 (how we ) Responsibilities • Oversee all Data and Safety Monitoring Boards (DSMB) activities, such as: determining individuals to serve on DSMBs and managing meetings logistics and summaries. • Advise NIA on optimal approaches to the implementation of clinical trials and privacy-related policies and regulations. • Provide regulatory guidance and strategy including identifying and assessing regulatory risks, mitigations, and contingencies. • Provide technical oversight and advice on the provision of subject matter experts for NIA clinical regulatory research activities, advisory panels, and monitoring bodies. • Advise NIA on clinical research data, assuring quality review of data entry and assurance for reporting, presentations, peer-reviewed manuscripts, or other materials requiring analyses. • Identify best practices in clinical research recruitment seeking to provide diversity, equity, and inclusion efforts across NIA clinical research recruitment. • Monitor for regulations, guidelines, and clinical trials changes ensuring integrity and data quality for NIA-funded clinical research studies. • Oversee technical development and maintenance of NIA clinical research Standard Operating Procedures and policies. Provide updates, presentations, and training for full adoption and compliance across NIA. • Perform, coordinate, and manage site visits, in-person or virtually, for clinical studies as needed by NIA, for monitoring data quality and overseeing the integrity of study procedures. • Support communication and coordination between NIA staff and NIA-funded investigators with respect to monitoring any Adverse Events or risks. • Ensure that regulatory documents are accurate, complete, and verifiable, and confirm compliance with regulatory requirements. • Supervise and oversee a team of clinical trials support professionals. Provide written updates on team progress and accomplishments to support government reporting and proposals. Requirements Minimum Education and Experience • Master’s degree in Biosciences or related field. • Minimum of 15 years’ relevant experience, with at least 10 years’ experience leading or overseeing clinical trials research or reporting, including experience in Good Clinical Practice, Human Subjects Protections, IRBs, clinical risk management reporting, and/or related areas Basic Requirements • Experience leading and implementing a comprehensive clinical research compliance, quality, or similar program. • Demonstrated strength in verbal and written communication skills, including presentation and training skills. • Ability to work productively in Microsoft Office Suite, including Microsoft SharePoint to accomplish tasks. • Highly organized, efficient, and extremely detail-oriented To be successful at Ripple Effect, you must be able to pay attention to details, clearly communicate, work independently, and have an eagerness to learn. Learn more about what it takes to become a Rippler . Skills That Set You Apart • Experience advising and training staff on the clinical research regulatory concerns and determining experts in clinical research quality assurance. • Experience as IRB Director or administrator • Familiarity and experience with NIH clinical trial policies from an oversight perspective. • Experience overseeing DSMB/OSMB/Safety Officers (SO), providing subject matter and regulatory expertise. • Experience with FDA and OHRP. If you don’t have all of the skills above, don’t be discouraged—no resume paints a complete picture of a person. There’s a good chance you’re more wonderful than you think, so please apply! About Ripple Effect Ripple Effect is an women-owned small business providing provides professional consulting and exceptional talent for federal, private, and non-profit clients. We deliver multi-disciplinary solutions across , , , , and solutions with a focus on science, research, and healthcare domains. | | | Benefits Ripple Effect rewards our employees for their contributions to our mission in many ways, from to a range of work/life programs based on your employment classification and personalized preferences. Ripple Effect is proud to be an equal opportunity workplace and is an affirmative action employer. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity, political affiliation, or Veteran status. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements. If you have a disability or special need that requires accommodation during the hiring process, please let us know by contacting our HR department at or your recruiter. Eligibility for employment will be verified using . Expected salary: $134500 - 154500 per year Location: Bethesda, MD Job date: Sun, 19 Feb 2023 06:38:00 GMT Apply for the job now! Apply tot his job Apply To this Job