Instagram
youtube
Facebook

Project Support Coord

0-4 years
Not Disclosed
10 Dec. 25, 2024
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science 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 Description: Project Support Coordinator (PSC)


Work Schedule

  • Type: Flexible
  • Environmental Conditions: Office-based

Key Responsibilities

  1. Trial Activity Coordination:

    • Manage, oversee, and execute assigned trial activities outlined in the task matrix.
    • Conduct departmental, internal, country, and investigator file reviews, document findings, and follow up for resolution.
  2. Task Management:

    • Ensure tasks are completed on schedule, within budget, and meet quality standards.
    • Address variances (e.g., overburn/underburn) for self and junior PSCs and redistribute tasks to optimize team capacity.
  3. Documentation and System Support:

    • Maintain and monitor study-specific documentation, tools, and trackers, including study team lists, training requirements, and project activity plans.
    • Provide system support (e.g., CTMS, Oracle Activate, eTMF) for study access requests, document supervision, audit readiness, and issue resolution.
  4. Administrative Support:

    • Process and review documents sent to CRG's/Client eTMF and coordinate issue resolution.
    • Manage mass communications, generate reports, and provide relevant documents to internal teams.
  5. Meeting Coordination:

    • Organize and schedule client/internal meetings, prepare meeting minutes, and follow up on action items when necessary.
  6. Data Analysis and Reconciliation:

    • Export, reconcile, and analyze study metric reports to identify and address potential issues.
  7. Vendor and Site File Management:

    • Maintain and verify vendor trackers for accuracy.
    • Coordinate and compile Investigator Site File (ISF) templates and pharmacy binders per clinical team instructions.
  8. Study Set-Up Support:

    • Participate in project kick-off and launch meetings, provide notes, and assist with initial study setup.

Education and Experience

  • Education:

    • High school diploma or equivalent.
    • Relevant formal academic or vocational qualification for technical positions (certificate may be required).
  • Experience:

    • 0–4 years of relevant experience, providing knowledge and skills to excel in this role.

Required Skills and Competencies

  • Strong organizational and multitasking abilities.
  • Proficiency in clinical trial management systems and tools (e.g., CTMS, Oracle Activate, eTMF).
  • Attention to detail and ability to ensure audit readiness.
  • Effective communication and coordination skills, including note-taking and follow-up.
  • Basic understanding of trial activity management and documentation processes.

Join our dynamic team to support groundbreaking clinical trials and drive innovation in healthcare solutions!