Opportunity to work as Clinical Research Coordinator - Ophthalmology Trials in Excel Life Sciences

Excel Life Sciences (ELS) is a U.S.-based, India focused, provider of comprehensive clinical trial management services, focusing on site performance, patient enrollment and on-time study completion.
ELS’ success is built around passionate and experienced individuals working alongside our clients to accelerate clinical research and deliver new drugs and medical devices to the markets, while maintaining the highest standards of quality. As a trial management organization, we are also committed to improving and expanding the clinical research enterprise in India, evident through our presentations at conferences, peer-reviewed publications, and continuing relationships with academic institutions.

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: 18^th July 2012