Clinical Research Jobs For Life Sciences at Hector Research and Archival Private Limited – Apply at Biotecnika
Job Title: Clinical Research Coordinator (CRC)
Company: Hector Research and Archival Private Limited
Location: Onsite at AIIMS Rishikesh
Salary Range: ₹4.0 – ₹4.5 Lakhs per annum
Experience: 1-2 Years
Eligibility Criteria:
• Qualification: BSc/MSc in Life Sciences, or Postgraduate with Clinical Research Degree/Diploma, B.Pharm, M.Pharm,
• Experience: Minimum 1–2 years of experience as a Clinical Research Coordinator (CRC)
Key Responsibilities:
• Identify new sites, PIs and conduct the detailed protocol specific feasibility.
• Preparation for site selection visit.
• IRB Submission & follow-up for Approval.
• Collection of Regulatory documents.
• Trial Master File (TMF) set up.
• Prepare site for Site Initiation Visit (SIV).
• Conduct study according to International Conference of Harmonization (ICH) E6 and Indian Good Clinical Practice (GCP) regulations.
• Assisting Principal Investigator in administering the Informed Consent Form process.
• Ensure protocol adherence and compliance.
• Pre-screening, screening, enrolling & recruiting patients.
• Creating and Preparing Source Documents and their templates.
• Coordinate and schedule subject’s regular follow-up visits and procedures, preventing lost to follow-up & missed visits. Maintaining regular contact with patients telephonically.
• Manage Clinical Trial Materials (CTM), accountability, distribution & logistics at site.
• Co-ordinate all site-specific queries-medical, administrative
• Filling the case reports forms and electronic case report forms and resolving all data queries in time on Data Clarification Forms (DCFs).
• Maintain and update Trial Master File, site binders and relevant files.
• Reporting and coordinating all Adverse Events & Serious Adverse Events according to their timelines.
• Filling up and maintaining trial related logs like source documentation, drug dispensing logs, subject logs, Investigational Product Logs, temperature logs. Etc.
• Maintaining Calibration records.
• Preparing Site for Monitoring & Audit visits, coordinate close out visit & Archival at site.
• Accurate and complete documentation of relevant EC documents.
• Communicating all protocol-related issues problems to the appropriate management staff including but not limited to questions regarding the conduct of trial, concerns regarding possible serious adverse events or subject compliance.
• To document protocol deviations as appropriate and communicate any impacting subject safety to the Ethics Committee.
• Coordinate Central Lab logistics & sample flow, Review Lab data & Communicate abnormal values to the primary care provider (if appropriate) & Investigator.
• Co-ordinate Subject reimbursements.
• Participating in business development efforts to assist GDD Experts, identify business that entails the implementation of clinical trials in India.
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