Only 24h Left Study Coordinator

3 weeks ago

Bengaluru, Karnataka, India St Johns Research Institute Sjri Full time
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

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