Key ResponsibilitiesStudy Coordination
- Coordinate clinical trials and research projects from initiation to close-out.
- Assist Principal Investigators (PIs) in study planning and execution.
- Ensure adherence to approved study protocols and timelines.
- Schedule and coordinate study visits, assessments, and follow-ups.
Participant Management
- Screen, recruit, and enroll eligible study participants.
- Conduct informed consent processes as per protocol and ethical guidelines.
- Maintain regular communication with participants throughout the study.
- Track participant compliance and retention.
Regulatory & Compliance
- Maintain essential study documents and regulatory files.
- Ensure compliance with ICH-GCP, CDSCO, NABH, and institutional requirements.
- Prepare and submit documentation to Ethics Committees/IRBs.
- Report protocol deviations, adverse events, and serious adverse events as required.
Data Management
- Collect, verify, and maintain accurate study data.
- Complete Case Report Forms (CRFs) and electronic data capture systems.
- Ensure timely data entry and query resolution.
- Maintain confidentiality and data integrity.
Sponsor & Site Coordination
- Coordinate with sponsors, CROs, monitors, and study teams.
- Support site initiation, monitoring, and audit visits.
- Facilitate study-related training and meetings.
Documentation & Reporting
- Maintain Trial Master Files (TMF) and Investigator Site Files (ISF).
- Prepare study progress reports and recruitment updates.
- Ensure all study records are audit-ready.
QualificationsEducation
- Bachelor's or Master's degree in Life Sciences, Pharmacy, Biotechnology, Clinical Research, Nursing, or related healthcare field.
Experience
- 1–5 years of experience as a Clinical Research Coordinator or Clinical Research Associate.
- Experience in oncology clinical trials will be preferred.
- Experience handling regulatory documentation and ethics committee submissions.
Required Skills
- Knowledge of ICH-GCP guidelines and clinical trial regulations.
- Strong documentation and organizational skills.
- Proficiency in Microsoft Office and clinical trial databases.
- Excellent communication and stakeholder management skills.
- Ability to manage multiple studies simultaneously.
- Attention to detail and compliance-focused approach.
Key Performance Indicators (KPIs)
- Study enrollment and retention rates.
- Protocol compliance and audit readiness.
- Timely regulatory submissions.
- Data quality and query resolution timelines.
- Sponsor and investigator satisfaction.
Pay: ₹25,570.09 - ₹31,374.66 per month
Work Location: In person
