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Clinical Trial Associate

Department: Clinical Development
Reports to: Director, Clinical Development Operations
Location: Office US-based

Summary of job description:
The Clinical Trial Associate (CTA) will be responsible for supporting the clinical operations team.  The CTA will participate in clinical activities to support and facilitate the efficient conduct of the clinical research goals.   The CTA will report to the Director Clinical Development Operations.

Key responsibilities:

  • Assist in the development of clinical trial documents including protocols, manuals, SOPs, trackers, policies.
  • Assist in preparation and documentation of internal and external meetings by preparing agendas and minutes
  • Assist in updates for all clinical trials tracking tools for Trial Master File (TMF), monitoring visits, enrollment, laboratory samples and clinical trial agents (drugs/biologics), data cleaning, other vendor tracking and training.
  • Assist in informed consent development and version tracking

Other Responsibilities:

  • Assist in reporting for Senior Management updates

Educational Requirements:

  • BS degree in science, nursing, allied health.  Other degrees/experience will be considered.

Experience and Skill Requirements

  • 2 to 4 years clinical research experience in industry or Contract Research Organization (CRO). Clinical Trial Coordinators from hospital settings will also be considered.
  • Knowledge and training on Good Clinical Practice (GCP) for clinical research studies
  • Experience working with clinical sites, principal investigators, clinical operations staff and CROs
  • Computer skill should include proficiency with Microsoft Office software

EEO & Employment Eligibility:

Replimune is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, ancestry origin, disability or veteran status. Replimune also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA.

Recruitment/Staffing Agencies:

Replimune, Inc. does not accept agency resumes unless contacted directly by internal Replimune Talent Acquisition. Please do not forward resumes to our careers site, employees or any other company location of Replimune. Replimune will not be responsible for any fees related to unsolicited resumes.