Opportunity to work as Clinical Research Coordinator - Ophthalmology Trials in Excel Life Sciences
Post: Clinical Research Coordinator - Ophthalmology Trials
Job Description:
CANDIDATES HAVING AT LEAST 2 YEARS OF EXPERIENCE IN OPHTHALMOLOGY TRIALS ONLY NEED TO APPLY, PLEASE DO NOT APPLY IF YOU DO NOT HAVE EXPERIENCE IN OPHTHALMOLOGY CLINICAL TRIALS
• 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 report
• 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
PROJECT SPECIFIC
• PI/site identification, assess manpower need & infrastructure capabilities, ensure timely enrollment
• Interact with Sites: Interact with PI and other study members on a regular basis, discuss potential issues and suggest corrective action
• Provide feedback/inputs to operations, regarding the process of a study
OTHER ACTIVITIES
• Conduct internet-based search
• Conduct Trial Feasibilities in the region
• Participate & conduct Cross Referral activities as per project/study requirements
• Observing, receiving, and otherwise obtaining information pertaining to Clinical Trials from all relevant sources
• Regulatory updates – Educate investigators & clinical research professionals
• Utilization of existing contacts ( Sites, Investigators, Industry, Vendors); & further development of database
• Any other assignment given by the management from time to time
Additional Information:
Experience: 1-5 years
Location: Delhi
Education: B.Pharm, M.Pharm, B.Sc, M.Sc
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: CR
End Date: 18th July 2012
Apply / Send resume at, sheeba@excellifesciences.com
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