Talent.com
This job offer is not available in your country.
Study Coordinator - TKA Project

Study Coordinator - TKA Project

ConfidentialBengaluru / Bangalore
9 days ago
Job description

Roles and Responsibilities :

Participant Coordination & Recruitment

  • Work under the guidance of the Investigator to assist with all study-related responsibilities
  • Conduct and document the informed consent process
  • Educate participants on study procedures, duration, risks, benefits, and compensation
  • Assist in subject enrollment and assign screening codes
  • Maintain follow-up communication with participants

Study Conduct & Compliance

  • Ensure strict adherence to GCP , Ethics Committee (EC) guidelines, and the approved protocol
  • Follow the Schedule of Assessments in coordination with the study team
  • Coordinate lab activities : sample collection, processing, packaging, and shipping
  • Ensure subject well-being and protocol compliance

    • Data Collection & Documentation

  • Maintain confidentiality while collecting and handling source data
  • Compile data from medical charts, lab reports, diaries, and questionnaires
  • Transcribe data from source documents to CRFs (Case Report Forms)
  • Ensure accuracy and completeness of data in CRFs
  • Report missing or inconsistent data to the Investigator or Manager
  • Resolve queries and document all relevant issues or deviations

    • Safety Monitoring

  • Record and report Adverse Events (AE) and Serious Adverse Events (SAE) per guidelines
  • Communicate safety concerns with P.I., monitor, sponsor, and EC

    • Regulatory & Site Coordination

  • Maintain and update the Site Master File (SMF) and study documentation
  • Coordinate with monitors for Site Initiation Visits (SIV) and Routine Monitoring Visits (RMV)
  • Support audits and inspections by sponsors or regulatory bodies
  • Manage study closeout activities

    • Logistics & Operations

  • Reorder study supplies as needed
  • Manage and document study subject payments (if applicable)
  • Record all essential communications and maintain logs

    • Skills Required

    study coordination , informed consent , Data Collection

    Create a job alert for this search

    Project Coordinator • Bengaluru / Bangalore