Sr. Clinical Research Scientist

Job title: Sr. Clinical Research Scientist
Reports to: Sr. Director, Clinical Research & Development

Job purpose:

The Clinical Research Scientist (CRS) will work with the Clinical Research Physician (CRP) for assigned protocols and/or projects, partnering with vendors and cross functional teams. The Clinical Research Scientist will make scientific contributions to current clinical programs, particularly in the implementation, analysis and reporting of clinical studies.

Duties and responsibilities Include but Not Limited To:

  • Participate in activities related to protocol data review, medical monitoring, query resolution, and study conduct oversight
  • Collaborate with team members in Data Management activities such as development of eCRFs, edit checks, report development and database lock processes
  • Support enrolment projections and assist with the development and implementation of subject recruitment and retention strategies
  • Contribute to the development of clinical protocols and other clinical documents, in close collaboration with cross-functional team members and external vendors
  • Support regulatory activities at the protocol level to develop, prepare and respond to regulatory authorities
  • Provide scientific review of statistical analysis plans
  • Collaborate on the review, analysis, and interpretation of study results
  • Assist in writing and/or providing scientific input, review, and edits of clinical study reports, Investigator Brochures, INDs, NDA annual reports, integrated medical reports, and other regulatory submissions
  • Support preparation of abstracts, manuscripts, presentations, and materials for external meetings as it relates to the assigned protocol(s) and/or clinical program

Qualifications include but not limited to:

  • A Bachelor’s degree in a scientific discipline and /or an advanced degree is preferred (eg PharmD, RN, PhD, PA, MD).
  • 3+ years experience in clinical development in the pharmaceutical/biotech or CRO industry, particularly in Phases II-III
  • Prior dermatology drug development experience preferred
  • Experience in ongoing data review, analysis and interpretation of clinical data (safety and efficacy) and a working knowledge of biostatistics, GCP, and regulatory requirements for clinical studies.
  • Excellent written and oral communication skills
  • Ability to multi-task and to work successfully in a lean, fast-paced, matrix team environment
  • High level of organizational and project management skills.

Travel:  Travel requirement approximately 5-10% based on protocol development stage and program needs

 

Candidates must be a U.S. citizen or lawful permanent resident of U.S. or otherwise authorized to work in the U.S. without requiring sponsorship now or in the future.

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