Excel Life Sciences Pvt. Ltd. India Headquarters
Country Head & Director - Operations
B-155, Sector-63, NOIDA-201301
Clinical Research Coordinator 1 Opening(s)
Experience: 1 - 3 Years
Location: Bhubaneshwar
Education:UG - Any Graduate - Any Specialization PG - Any PG Course - Any Specialization
Desired Candidate Profile
Site & PI identification as per the needs, Protocol, IRB submission, Site set up, Document collection Create source document template, Prepare site for SIV, Pre screening, Enroll & Follow Up, Post trial Activities, Coordinate Central Lab logistics etc
Job Description
Trial related:
• Identification of potential investigators/Sites and ongoing review/development
• Conduct of ICH GCP,ICMR/DCGI Guidelines, Study Specific Training on a regular basis at the sites
• Scan Patients data and short listing of patients
• Help the investigator in screening patients
• Assisting investigators in the Informed Consent Process, coordination and management of laboratory samples, courier and follow-ups of lab reports
• Drug accountability and dispensing at the site
• IVRS (Interactive Voice Responsive Services) for patient’s randomization in randomized studies
• Investigational product management, dispensing, temperature monitoring and accountability
• Ensure compliance of project specific schedule of activities
• Ensure compliance of SOPs (both internal & external as applicable)
• Preparation, attendance and follow-up of monitoring
• Completing CRF entry with minimal error.
• Preparation, attendance and follow-up of Audit
• Trial closeout: preparation, attendance and follow-up; forwarding the necessary information of site closeout to all concerns
• Manage & Develop the Investigators in the respective region
• Verify the accuracy and validity of data entered in databases; correct any errors
• Prepare tables, graphs, fact sheets, and written reports summarizing research results
• Submit reports & research findings to internal & external customer
• Compiling verifying information or data
• Manage patient travel reimbursement
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