Clinical Protocol Development Specialist

Updated: June 21, 2018
Job ID: 213076
Status: Full-Time
Regular/Temporary: Regular
Location: Rockville, MD, United States

Join the HJF Team!

HJF is seeking a Clinical Protocol Development Specialist to support the Center for Neuroscience and Regenerative Medicine (CNRM) Clinical Trials Unit in Rockville, Maryland. HJF provides scientific, technical and programmatic support services to CNRM.

Responsibilities are to provide direct support to the Senior Program Manager and Clinical Research Associate (CRA) relating to research, clinical, and policy areas for a specified program.

The CPDS is responsible for the operational support activities for a protocol.  In addition, the CPDS works closely with internal project team members to ensure compliance with regulatory requirements, ICH guidelines, CNRM Standard Operating Procedures (SOPs) and policies, the study protocol, and overall research objectives.

Responsibilities:

  1. Participates in the protocol development process under the Senior Program Manager. This includes maintaining all correspondence, facilitation of protocol team meetings, serving as recorder for review committees and protocol team, and assisting the Principal Investigator with preparing protocols and protocol related documents.
  2. Provides information for the protocols such as clearance forms, data forms, rosters.  Also prioritizes all administrative needs and assures that protocols are expedited in a timely fashion.
  3. Responsible for providing Principal Investigators with written documentation of protocol team comments, reviews, and communications including approval for IRB submission.
  4. Collaborates with the project team and CNRM Core personnel to determine data, specimen, and imaging collection requirements based on the study protocol.
  5. Responsible for submission of protocol documents for institutional review.
  6. Assist CNRM CRA with the filing and storage of regulatory documents.
  7. Supports CNRM CRA with review and submission of required reports, such as SAE and protocol deviation reports, accrual and other study status and/or study web site reports.
  8. Maintains protocol documentation required by the sponsor and project SOPs.
  9. Attends and participates in project and functional group meetings and in continuing education activities.
  10. Establishes and maintains effective working relationships with internal and external study personnel.
  11. Performs other duties as assigned.

Required Knowledge, Skills, and Abilities:   knowledge of general office procedures; knowledge of protocols and policies and procedures associated with them; excellent communication and computer skills; ability to handle multiple tasks.  Possesses detailed knowledge of the protocol development process, inclusive of protocol writing and submission, and its associated activities and timelines.  Previous experience with US Department of Defense funded research preferred.

Minimum Education/Training Requirements:  Bachelor’s Degree in a related scientific field; psychology, biology, neurology

Minimum Experience:    2 to 4 years’ experience.

Work Environment:  office/laboratory environment

HJF is an equal opportunity and affirmative action employer.  All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

Any qualifications to be considered as equivalents, in lieu of stated minimums, require the prior approval of the Director of Human Resources.

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