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Project Support Coord

0-4 years
Not Disclosed
10 Dec. 11, 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
Location: Office-Based
Employment Type: Full-Time
Posted: 12/11/2024

About the Role:

We are looking for a Clinical Trial Coordinator to join our dynamic team. In this role, you will oversee, coordinate, and complete various trial activities as detailed in the task matrix. Your responsibilities will include supporting study documentation, ensuring compliance, and contributing to the smooth operation of clinical trials.

Responsibilities:

  • Task Coordination: Manage and complete assigned trial activities, ensuring tasks are performed on time, within budget, and at a high-quality standard.
  • File Reviews: Conduct internal, country, and investigator file reviews, document findings, and follow up on any issues to resolution.
  • Task Management: Ensure that allocated tasks are distributed to junior PSCs based on their capacity, and address any variances (overburn/underburn).
  • Documentation Oversight: Assist with the maintenance of study-specific documentation, and manage tools and trackers for project-specific training, access management, and activity planning.
  • System Support: Manage access requests and oversee study-level documents on systems like CTMS, Oracle Activate, and eTMF. Ensure audit readiness and non-compliance resolution.
  • Administrative Support: Process and review documents in eTMF, handle communications, perform mass mailings, and provide reports to internal teams.
  • Meeting Coordination: Organize client and internal meetings, distribute meeting minutes, and track the completion of action items.
  • Metrics Reporting: Export and reconcile study metrics reports, identify issues, and resolve them as needed.
  • Vendor Tracker Management: Regularly review and maintain vendor trackers for accuracy.
  • Investigator Site File Compilation: Assist with the compilation of the Investigator Site File (ISF) template and pharmacy binder.
  • Study Setup: Attend Kick-Off and Project Launch meetings, take notes, and support initial study setup.

Education and Experience:

  • Education: High/Secondary School diploma or equivalent, with relevant formal academic or vocational qualifications.
  • Experience: Previous experience in a similar role is preferred (0 to 4 years), providing the necessary knowledge, skills, and abilities to perform the job effectively.
  • Certifications: Technical positions may require a certificate.

Why Join Us?

  • Work Environment: Office-based role with a supportive and collaborative team.
  • Growth Opportunities: Develop your skills and experience in clinical trial management.
  • Benefits: Enjoy thoughtful benefits designed to enhance your health and well-being.

Apply Now:

Ready to make a difference in clinical trials? Apply today through our website at Biorasi Careers or email your resume to careers@biorasi.com.