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Project Support Coord

0-4 years
Not Disclosed
10 Dec. 18, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Clinical Trial Coordinator - Job Description

Job Title: Clinical Trial Coordinator
Work Schedule: Office-based
Environmental Conditions: Office Environment

Job Description:

The Clinical Trial Coordinator oversees and completes assigned trial activities according to the task matrix. They perform department, internal, country, and investigator file reviews, documenting findings and following up for resolution when necessary.

Key Responsibilities:

  • Coordinates and completes tasks assigned in the trial activities matrix.
  • Conducts department, internal, country, and investigator file reviews, documenting findings and following up for resolution.
  • Ensures tasks are completed on time, within budget, and to a high-quality standard. Alerts about variances and redistributes tasks as needed.
  • Supports the maintenance and oversight of study-specific documentation and global systems, including tracking project-specific training, system access, and project level activity plans.
  • Provides system support (CTMS, Oracle Activate, eTMF), managing access requests, supervising documents, maintaining audit readiness, and addressing non-compliance.
  • Handles administrative tasks, such as processing documents to CRGs/Client eTMF, performing reviews, proposing issue resolutions, and distributing mass mailings or communications.
  • Coordinates and schedules client/internal meetings, prepares meeting minutes, and follows up on action items.
  • Exports and reconciles study metrics reports, identifies issues, and takes action if leading the role.
  • Maintains and checks vendor trackers for correctness.
  • Coordinates the compilation of Investigator Site Files (ISF) and pharmacy binders with instructions from the Clinical Team Manager.
  • Attends Kick-Off and Project Launch meetings, takes notes, and supports initial study setup.

Education and Experience:

  • High school diploma or equivalent, with relevant formal academic/vocational qualifications.
  • Technical positions may require certification.
  • Previous experience (0 to 4 years) providing the necessary knowledge, skills, and abilities to perform the job effectively.