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
We are a trusted government partner that blends deep domain expertise with advanced technologies to help our customers solve complex problems that improve, protect, and save lives. As a rapidly growing company, we combine entrepreneurial spirit, customer focus, and an outcomes-based approach to support agency missions in health IT, life sciences, public safety, and grants management.
The Dovel Family of Companies offers employees an opportunity to advance beyond a specific role or contract, we offer a path to develop an enriching career. We believe in empowering a culture of innovation, customer success, and employee growth.
What you’ll get…
- Time Off! Flexible schedules and company paid holidays allow you to take the time you need.
- Investment in YOU! 401(K) company contributions are yours to keep with no waiting period.
- Choices! Unique healthcare plans to choose from with options like fertility and orthodontia benefits.
- Discovery! With our tuition assistance and training programs, we support your career advancement.
- Tax Savings! Enroll in pre-tax Health or Dependent Care Flexible Spending, HSA with company contributions, parking, and/or transit commuter benefits.
- Support! Working parents and busy professionals – we’ve got you covered with a supportive culture, confidential Employee Assistance Program and a membership to Care.com.
- Perks! Employee discounts, peer recognition programs, company-wide wellness challenges, and fun community events.
- A Voice! A unique culture where you can influence decisions and have your voice heard.
We are an Equal Opportunity Employer with a commitment to diversity. All individuals, regardless of personal characteristics, are encouraged to apply. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, sexual orientation, gender identity, disability, or veteran status.