Study Coordinator - TKA Project

Location: Bengaluru

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