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