Clinical Research Coordinator

5 days ago

Ludhiana Punjab, India Christian Medical College Ludhiana Society Full time

**Location: Garo Hills, Meghalaya**

**Employment Type**: Contractual

**Reports To**: Principal Investigator or Clinical Research Manager

**Position Overview**: The Clinical Research Coordinator (CRC) plays a vital role in managing and conducting clinical research studies, ensuring they comply with regulatory, ethical, and institutional guidelines. The CRC acts as a bridge between the research team, study participants, and sponsor organizations to facilitate smooth operations, data integrity, and participant safety.

**Key Responsibilities**

**Study Coordination and Management**
- Coordinate all aspects of clinical trials, including patient recruitment, screening, enrollment and follow-ups.
- Schedule and monitor study visits and procedures in adherence to the study protocol.
- Maintain accurate and detailed study documentation, including informed consent forms, case report forms (CRFs), and source documents.
- Ensure all study activities align with Good Clinical Practice (GCP) and applicable regulatory requirements.

**Participant Interaction**
- Serve as the primary point of contact for study participants, addressing questions and concerns professionally and empathetically.
- Administer informed consent and explain study procedures to participants in understandable terms.
- Monitor participants’ health and safety during the trial, reporting adverse events promptly.

**Data Management**
- Collect, enter, and verify study data in electronic or paper systems.
- Perform quality checks to ensure data accuracy and completeness.
- Prepare data reports for sponsor organizations, Principal Investigators (PIs), and regulatory bodies.

**Compliance and Regulation**
- Ensure compliance with institutional review board (IRB) guidelines, regulatory agencies, and sponsor requirements.
- Prepare and submit regulatory documents, including IRB amendments, adverse event reports, and annual reviews.
- Participate in audits and inspections by regulatory authorities or sponsors.
- Collaboration and Communication
- Work closely with Principal Investigators, clinical staff, and sponsor representatives to ensure the successful execution of trials.
- Attend training sessions, team meetings, and sponsor-provided workshops to stay updated on protocols and regulations.
- Coordinate with laboratory and pharmacy staff for specimen collection, storage, and shipment.

**Qualifications and Skills**

**Education**
- Bachelor’s degree in life sciences, nursing, or a related field (Master’s preferred).

**Experience**
- At least 1-2 years of experience in clinical research or healthcare settings (preferred).
- Knowledge of GCP, ICH guidelines, and clinical trial processes.

**Skills**
- Strong organizational and time-management skills.
- Excellent written and verbal communication abilities.
- Proficient in data entry and management tools, including electronic data capture (EDC) systems.
- Attention to detail and ability to multitask in a fast-paced environment.
- Empathy and professionalism in dealing with diverse patient populations.

**Why Join Us?**
- Opportunity to contribute to groundbreaking clinical research and patient care.
- Professional growth and development opportunities.

To apply, please submit your resume and a cover letter.

**Job Types**: Full-time, Fresher

Pay: ₹30,000.00 per month

Schedule:

- Day shift
- Morning shift

Work Location: In person

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