Director of Clinical Operations (Center for Neuroscience and Regenerative Medicine)

Updated: December 4, 2018
Job ID: 213844
Status: Full-Time
Regular/Temporary: Regular
Location: Rockville, MD, United States

Join the HJF Team!

HJF is seeking a Director of Clinical Operations to support the Center for Neuroscience and Regenerative Medicine (CNRM) in Rockville, Maryland.  The Director of Clinical Operations will be responsible for leading the activities in the preparation, implementation, and completion of various clinical trials in accordance with the Program research development plan and mission. HJF provides scientific, technical and programmatic support services for CNRM.

Responsibilities:

  1. Lead in-house Clinical Operations
  2. Work with Program Leadership to develop and drive study timelines and study implementation and operational plans.
  3. Interface with the CNRM Program staff regarding follow-up of status of project activities and deliverables (including but not limited to site identification and selection, pre-trial activities, enrollment, management/conduct, database lock, post-study activities)
  4. Proactively identifies project risks and resolves with some supervision, as needed
  5. Review and prepare various clinical study documents including but not limited to model informed consent forms, study protocol and amendments, and Investigator Brochure.
  6. Represent Clinical Operations in cross-functional initiatives – work closely with clinical research teams, and translational and pre-clinical research colleagues.
  7. Manage other Clinical Operations staff
  8. Provide strategic input into the development of clinical trial protocols to ensure clinical designs are implementable to efficiently achieve the objectives
  9. Provide strategic input into the collection and analysis of clinical trial data
  10. Lead the development of contingency/risk management plans for projects with a focus on ensuring studies delivery according to principles of Good Clinical Practice (GCP)
  11. Lead development and review of clinical operations processes, systems and initiatives
  12. Performs other duties as assigned.

Required Knowledge, Skills, and Abilities:  Demonstrated effective planning and project management skills, proven track record of conducting, managing clinical trials, excellent written and verbal communication skills, strong management and collaborative skills with demonstrated ability to effectively mentor study managers and clinical trial staff, ability to effectively manage interactions with internal and external collaborators to achieve program goals.

Minimum Education/Training Requirements: Bachelor’s degree in biology or related science

Minimum Experience:  6 or more years of progressive clinical operations experience. Previous experience in a medical or scientific environment and DoD funded research preferred.  Domestic travel may be required up to 10%.

Physical Capabilities:  Frequent standing, sitting walking, traveling

Work Environment:  Office

Background: Eligible to obtain a Common Access Card (CAC) background.

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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