Overview

Responsibilities

• Assist Principal Investigators in the planning, development, and implementation of clinical.
• protocols for evaluation of VRC 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, statisticians, research nurses, pharmacists, regulatory personnel, and support staff.
• Ensure that advice and actions of CTP staff on the study 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, support the dissemination of information on vaccine, monoclonal antibody and other
• VRC clinical trials and respond to related inquiries from sites, sponsors, FDA, and other regulatory agencies.
• Assist with quality management activities for the CTP 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 recommendations for any identified necessary changes.

• Bachelor’s degree in Life Sciences or a related discipline.
• Experience in clinical trials development and management.
• 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 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 skills 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.

• 100% Medical, Dental & Vision premium coverage for Employees
• Paid Time Off (Including Holidays)
• Employee Referral Bonus
• 401K Match
• Tuition reimbursement and professional development opportunities
• Flexible Spending Accounts:
• Healthcare (FSA)
• Parking Reimbursement Account (PRK)
• Dependent Care Assistant Program (DCAP)
• Transportation Reimbursement Account (TRN)

The diversity of Axle’s employees is a tremendous asset. We are firmly committed to providing equal opportunity in all aspects of employment and will not tolerate any illegal discrimination or harassment-based age, race, gender, religion, national origin, disability, marital status, covered veteran status, sexual orientation, status with respect to public assistance, and other characteristics protected under state, federal, or local law and to deter those who aid, abet, or induce discrimination or coerce others to discriminate.