Study Coordinator

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