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Project Support Coord

4+ years
Not Disclosed
10 Oct. 30, 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

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

Job Description:
As a Clinical Trial Coordinator, you will be responsible for coordinating, overseeing, and completing assigned trial activities as detailed in the task matrix. Your key responsibilities will include:

  • Performing departmental, internal, country, and investigator file reviews, documenting findings, and following up on resolutions.
  • Ensuring tasks are completed on time, within budget, and to high-quality standards. Address variances (overburn/underburn) for yourself and junior Project Support Coordinators (PSCs) while redistributing tasks based on junior PSCs’ availability.
  • Supporting the maintenance of study-specific documentation and global support with systems, tools, and trackers, including study team lists, project-specific training requirements, system access management for organizations/vendors/clients, and tracking project-level activity plans.
  • Providing support for systems like CTMS, Oracle Activate, and eTMF by managing access requests, supervising study-level documents, maintaining audit readiness, and addressing non-compliance with the study team, suggesting resolutions.
  • Performing administrative tasks for assigned trials, including timely processing of documents sent to CRG's/Client eTMF, coordinating issue resolutions, performing mass mailings, and providing documents and reports to internal team members.
  • Supporting the scheduling and organization of client and/or internal meetings, completing and distributing meeting minutes, and following up on action items as required.
  • Exporting and reconciling study metrics reports, analyzing and identifying issues if involved in a lead role.
  • Maintaining and regularly checking the accuracy of vendor trackers.
  • Driving and coordinating the compilation of Investigator Site File (ISF) templates and pharmacy binders with guidance from the Clinical Team Manager.
  • Attending Kick-off and Project Launch meetings, taking notes when required, and supporting initial study setup.

Education and Experience:

  • High/Secondary school diploma or equivalent, along with relevant formal academic/vocational qualifications.
  • Technical positions may require a certificate.
  • Previous experience providing the knowledge, skills, and abilities to perform the job (comparable to at least 4 years).