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Sr Clinical Trial Coordinator / Clinical Trial Coordinator Ii

4+ years
Not Disclosed
10 Sept. 25, 2025
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/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:

Sr Clinical Trial Coordinator / Clinical Trial Coordinator II

Location:

Remote, India (Fully Remote)

Job ID:

R-01329124

Job Type:

Full-time

Category:

Clinical Research / Clinical Trial Coordination

Work Schedule:

Second Shift (Afternoons)

Work Environment:

  • Office-based

  • Remote coordination with global teams

  • Use of clinical systems and databases


About the Role:

Provides administrative and technical support to the project team. Coordinates and facilitates project activities, acting as a cross-functional liaison. May serve as a study lead or buddy during onboarding, providing training to new staff. Supports process improvement initiatives and ensures project activities are completed efficiently and in compliance with regulatory standards.


Key Responsibilities:

Project & Trial Coordination:

  • Coordinates, oversees, and completes assigned trial activities as per task matrix (central or local role).

  • Performs departmental, internal, country, and investigator file reviews; documents findings in appropriate systems.

  • Maintains study-specific documentation and global support tools, including:

    • Study team lists

    • Tracking project-specific training requirements

    • System access management

    • Project activity plans

  • Ensures (e)TMF is up to date; follows file review schedules and documents findings.

  • Supports RBM (Risk-Based Monitoring) activities.

Administrative Support:

  • Processes documents sent to clients via (e)TMF.

  • Performs mass mailings and communications.

  • Provides documents and reports to internal teams.

  • Supports scheduling and organization of client/internal meetings; prepares meeting minutes.

Regulatory & Documentation Support:

  • Reviews and tracks local regulatory documents.

  • Transmits documents to clients and centralized IRB/IEC.

  • Assists with coordination, compilation, and distribution of Investigator Site Files (ISF), Pharmacy binders, and study supplies.

  • Supports study-specific translations and quality control of translation materials.

  • May attend kick-off meetings and take notes.

Metrics & Reporting:

  • Analyzes and reconciles study metrics and findings reports.

  • Assists with clarification and resolution of site documentation findings.

  • Maintains vendor trackers.


Qualifications & Experience:

Education:

  • Bachelor’s degree preferred.

Experience:

  • 4+ years in a Clinical Trial Coordinator role.

  • Experience with Veeva Vault & CTMS tools.

  • Experience with eTMF systems.

  • Experience supporting global clinical trials and project managers.

Skills & Competencies:

  • Ability to work independently or in a team.

  • Strong organizational skills and attention to detail.

  • Ability to handle multiple tasks efficiently.

  • Ability to analyze project-specific data for accuracy and efficiency.

  • Strong customer focus.

  • Flexibility and adaptability to reprioritize workload.

  • Working knowledge of applicable country regulations, ICH GCP, SOPs, and WPDs.

  • Excellent English language and grammar skills; local language skills as needed.

  • Good presentation and interpersonal skills.

  • Proficient in MS Office (Word, Excel, PowerPoint) and ability to learn clinical trial database systems.

  • Self-motivated with a positive attitude.