Sr. Clinical Trial Protocol Specialist at Kelly Sr. Clinical Trial Protocol Specialist at Kelly in Cabin John, Maryland Posted in about 14 hours ago.

Type:

full-time Kelly Government Solutions is a strategic supplier and business partner to the federal government and its key suppliers. We are seeking a Senior Clinical Trial Protocol Specialist to work on-site with the Vaccine Research Center at the National Institute of Allergy and Infectious Diseases (NIAID)/National Institutes of Health (NIH) in Bethesda, MD. This is a long-term contract position which offers:

• Competitive compensation and comprehensive benefit package
• Optional health, vision, and dental plans
• Paid leave, paid federal holidays, and 401K plan.
• Access to NIH's unparalleled resources and niche scientific initiatives

KEY TASKS

(1) Work with Principal Investigators in the designing, development, drafting, and implementation of clinical protocols for evaluation of Vaccine Research Center investigational vaccine and monoclonal antibody products. (2) Ensure that clinical research protocols, consent forms, Investigator Brochures and other clinical research documents comply with applicable regulatory requirements defined by the Code of Federal Regulations (CFR) and Good Clinical Practice guidelines. (3) Ensure that data collection plans are consistent with applicable regulatory requirements and the protocol objectives. (4) Assist in protocol training, study implementation, site management and reporting of study outcomes. (5) 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. (6) 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. (7) 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. (8) Using systems for data management and document control, support the dissemination of information on vaccine, monoclonal antibody and other clinical trials and coordinate response to related inquiries from sites, sponsors, FDA, and other regulatory agencies. (9) Assist with quality management activities by reviewing and developing policies and procedures and providing support to risk assessment and clinical monitoring activities. (10) Design and conduct assessments of quality management and regulatory performance with respect to the achievement of program goals and objectives; recommend any identified necessary changes

KEY REQUIREMENTS

(1) Master's degree in Life Sciences or related discipline. Two years of specialized experience plus a bachelor's degree is equivalent. (2) Minimum of two (2) years of clinical research experience.

Demonstrated expertise in the fundamentals of clinical trials including clinical trial study design and development, drafting protocols, amendments, and study documents, clinical research policies and procedures, clinical data management, and data analysis. Familiarity with IRB requirements and related regulatory requirements and reports. (3) Experience to review, collect, assess, and summarize scientific and other complex data and information related to the development of investigational products as part of the design of clinical trial protocols (4) Knowledge of tools and software such as MS Word, clinical data management systems, medical publication databases, document control systems, and other information systems that support clinical research.