Clinical Research Coordinator (CRC)
Company: CuraClin SMO
Location: Bhubaneswar / Cuttack, Odisha
Department: Clinical Research
Job Type: Full-Time
JOB OVERVIEW
The Clinical Research Coordinator (CRC) is responsible for coordinating and managing day-to-day clinical trial activities at the investigational site. The role involves supporting patient recruitment, informed consent, study documentation, regulatory compliance, subject follow-up, data collection, and coordination with investigators, sponsors, CROs, and ethics committees to ensure clinical studies are conducted in accordance with ICH-GCP, study protocols, and applicable regulatory requirements.
KEY RESPONSIBILITIES
Clinical Trial Coordination
Coordinate clinical research studies.
Support study start-up activities.
Schedule subject visits.
Coordinate investigator meetings.
Manage trial timelines.
Ensure protocol compliance.
Assist in study close-out activities.
Patient Management
Screen potential study participants.
Support patient recruitment.
Coordinate informed consent process.
Schedule follow-up visits.
Monitor patient compliance.
Maintain participant records.
Coordinate subject retention activities.
Clinical Documentation
Maintain Trial Master File (TMF).
Maintain Investigator Site File (ISF).
Complete source documentation.
Update Case Report Forms (CRFs/eCRFs).
Maintain essential documents.
Ensure documentation accuracy.
Archive study records.
Data Management
Enter clinical data into EDC systems.
Review study data for accuracy.
Resolve data queries.
Perform data reconciliation.
Ensure data integrity.
Maintain confidentiality of patient data.
Regulatory Compliance
Ensure compliance with ICH-GCP.
Follow study protocols.
Maintain regulatory documentation.
Coordinate Ethics Committee submissions.
Assist during regulatory inspections.
Support audit readiness.
Ensure adherence to SOPs.
Safety Reporting
Identify adverse events (AEs).
Report serious adverse events (SAEs).
Document safety information.
Coordinate safety follow-up.
Maintain safety documentation.
Study Drug & Sample Management
Coordinate investigational product accountability.
Maintain drug storage records.
Track drug dispensing and returns.
Coordinate laboratory sample collection.
Arrange sample shipment.
Maintain laboratory documentation.
Communication & Coordination
Liaise with Principal Investigators.
Coordinate with sponsors and CROs.
Communicate with ethics committees.
Schedule monitoring visits.
Support site monitoring activities.
Participate in study meetings.
Quality Assurance
Ensure protocol adherence.
Maintain quality standards.
Support monitoring visits.
Prepare for audits and inspections.
Implement corrective actions when required.
EDUCATIONAL QUALIFICATIONS
Preferred
B.Pharm
M.Pharm
PharmD
BSc Nursing
MSc Nursing
BDS
MBBS
BSc Life Sciences
MSc Life Sciences
Biotechnology
Biochemistry
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Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Pondicherry (Puducherry) :
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Remote, India | Siliguri |Illinois :
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Germany | GErmany |Lower Saxony :
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Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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Norway | NOrway |Romania :
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Queensland |Melbourne :
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Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
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Auckland |New Zealand :
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Manila |Croatia :
Croatia |Zagreb :
Zagreb |Estonia :
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