Clinical Protocol Coordinator
We are currently searching for a Clinical Protocol Coordinator 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
- Assist Principal Investigators in the planning, development, and implementation of clinical protocols for evaluation of investigational vaccine and monoclonal antibody products.
- Ensure that clinical research protocols, consent forms, Investigator Brochures and other clinical research documents are in compliance with applicable regulatory requirements defined by the Code of Federal Regulations (CFR) and Good Clinical Practice guidelines.
- Ensure that data collection plans are consistent with applicable regulatory requirements and the protocol objectives.
- Assist in protocol training, study implementation, site management and reporting of study outcomes.
- Design, write and develop documents related to the use of investigational products, including but not limited to: conducting background research, reviewing and interpreting scientific and technical information, technical writing, ensuring compliance with regulatory requirements, and preparing or editing scientific summaries, presentations and publications.
- Prepare and review 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.
- Manage protocol and trial development by working and coordinating with clinical research teams that include physicians, laboratory scientists, research nurses, pharmacists, regulatory personnel, and support staff.
- Ensure that advice and actions of staff are consistent with Institute, NIH, and DHHS goals and policies, as well as with applicable statutes, regulations, rules, and directives.
- Manage clinical trial activities and communications with study team members throughout the protocol life cycle.
- 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 from sites, sponsors, FDA, and other regulatory agencies.
- Assist with quality management activities for the program by reviewing and developing policies and procedures and provide support to risk assessment and clinical monitoring activities.
- Design and conduct assessments of quality management and regulatory performance with respect to the achievement of program goals and objectives.
- Prepare plans and recommendation for any identified necessary changes.
- Master’s degree in Life Sciences or other related discipline. Two (2) years of specialized experience plus a BA/BS degree is equivalent to a Master’s degree.
- Experience in clinical trials development and management is required.
- Health-related, clinical research or clinical care experience as well as broad knowledge of the procedures and policies related to clinical trials research is required.
- Knowledge of and the ability to design human clinical trials protocols and the analytical skill to identify and resolve potential problems related to clinical research and regulatory activities or requirements is required.
- 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.
- Ability to review, collect, assess and summarize scientific and other complex data and information related to the development of investigational products.
- 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.
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.
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