We are currently searching for a Protocol Specialist to provide support to the National Institutes of Health (NIH). This opportunity is a full-time position with MSC, and it is on-site in Bethesda, MD.
Duties & Responsibilities
- Direct protocol design, study implementation, IND submissions, IRB submissions, document control and compliance with NIH and Federal regulations. These duties will include ensuring that clinical research protocols, consent forms, investigator brochures and other clinical research documents to support IND submissions for vaccine products are developed in compliance with applicable regulatory requirements defined by the Code of Federal Regulations (CFR) and guidelines related to IND Applications for investigational study agents, Informed Consent Documents, and Good Clinical Practice and that data collection plans are consistent with regulatory requirements and the protocol objectives.
- Design and develop clinical research protocols for the use of investigational new vaccine and related products, including but not limited to: conducting background research, reviewing and interpreting scientific and technical information, technical writing, ensuring compliance with regulatory requirements, study data collection management and preparation or editing of scientific documents and publications.
- Prepare regulatory submissions, annual reports, IND safety reports, human subjects experience sections for investigator brochures and other supporting documents for vaccine and other related product types.
- Ensure that advice and actions of staff are consistent with Institute, NIH, and DHHS goals and policy, as well as with applicable statutes, regulations, rules, and directives; support the preparation of INDs for submission to the FDA for approval to initiate clinical studies of HIV vaccines, emerging infection vaccines and other investigational products.
- Development of IND applications for adequacy of required documentation, scientific content, and conformance with applicable FDA regulations; may include new products for which no standards or procedures exist for determining safety and effectiveness, and review and evaluation requires extensive coordination with program, and outside medical and scientific experts.
- Respond to correspondence from FDA regarding vaccine and related product IND applications and amendments. Interact with collaborators to research, obtain and prepare answers for FDA questions directly related to trial design and implementation.
- Use information technology/telecommunication systems for data management and document control, supports the dissemination of information on vaccine, monoclonal antibody and other clinical trials and responds to related inquiries by sites, sponsors, FDA, and other regulatory agencies.
- Continuous updates and amendments of vaccine and other related product INDs with all pertinent information, such as annual reports, adverse drug reactions, protocols for clinical investigations, warning to investigators about adverse reactions, and any other additional data as required by FDA regulations. Manage the reviews and summarization of a variety of reports, including participant data for incorporation into annual reports and other study documents with accompanying recommendations. Such reports and recommendations are used by program medical staff and intramural investigators, and the FDA in determining the future course of vaccine protocols
- Determine the need for, and prepare or oversee the preparation of, technical and administrative guides, standards, manuals, reports and criteria related to accomplishing the objectives of national and international vaccine trials programs that collaborate with program. Typically, the issues cut across NIH organizational lines and require coordination of representatives of various branches, groups, pharmaceutical companies, and contractors
- Negotiate with senior Program and staff on issues within the purview of clinical protocol design. Participate as an expert at meetings, conferences, and symposia relating to clinical trials for vaccines and related products and INDs
- Assist the Chief in setting program priorities, developing policies, and defining associated requirements for regulatory oversight of clinical trials. Design and conduct assessments of regulatory performance with respect to the achievement of program goals and objectives. Prepare plans and recommendations for any identified necessary changes.
- Must have knowledge of the biological or health sciences gained through advanced education (e.g., MA, M.S., M.P.H., M.S.N., NP, PA, Ph.D.) or equivalent training.
- Minimum of two (2) years-experience in protocol writing for vaccines/biologics to start.
- Must have health-related, clinical research or clinical care experience as well as broad knowledge of the procedures and policies related to clinical trials research.
- Must have knowledge of and the ability to design human clinical trials protocols and the analytical skill to identify and resolve potential protocol problems related to clinical research and regulatory activities or requirements.
- Must have knowledge of and the ability to be a liaison between Divisions, NIH Institutes, other IND sponsors or clinical researchers.
- Ability to review, collect, assess, and summarize scientific and other complex data and information related to the development of vaccines.
- Excellent oral and written communication skills, technical writing skills, and organizational skills as applied to scientific and clinical teams engaged in the development of new investigational vaccines, monoclonal antibodies, or related product types.
- Knowledge of and skilled in the use of personal computers and software programs such as Microsoft Word, Clinical Data Management Systems (CDMS), medical publication databases, document control systems and other information systems that support clinical research.
Due to our contractual requirements, to be eligible for this role, you must be fully vaccinated against COVID-19 at time of hire.Company Description
Dovel Technologies and its Family of Companies (Medical Science & Computing and Ace Info Solutions) was acquired in October 2021.
Guidehouse is a leading global provider of consulting services to the public sector and commercial markets, with broad capabilities in management, technology, and risk consulting. By combining our public and private sector expertise, we help clients address their most complex challenges and navigate significant regulatory pressures focusing on transformational change, business resiliency, and technology-driven innovation. Across a range of advisory, consulting, outsourcing, and digital services, we create scalable, innovative solutions that help our clients outwit complexity and position them for future growth and success. The company has more than 12,000 professionals in over 50 locations globally. Guidehouse is a Veritas Capital portfolio company, led by seasoned professionals with proven and diverse expertise in traditional and emerging technologies, markets, and agenda-setting issues driving national and global economies.
Guidehouse is an Equal Employment Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, national origin, ancestry, citizenship status, military status, protected veteran status, religion, creed, physical or mental disability, medical condition, marital status, sex, sexual orientation, gender, gender identity or expression, age, genetic information, 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 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 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.