Newlife research

Vadodara, Gujarat

1) Identify new sites. PIs and conduct the detailed protocol specific feasibility.2) Preparation for site selection visit3) IRB submission & approval4) Regulatory document collection5) Set-up. maintain & timely update or Trial Master File(TMF) & relevant site binders Files6) Prepare site for Site Initiation Visit (SIV)7) Assisting Principal Investigator in administering the Informed Consent Form process8) Ensure protocol adherence and Compliance; t document protocol deviations as appropriate and communicate any impacting subject safety to !he Ethics Committee. 9) Pre-screening, screening, enrolling & recruiting subjects.10) Creating and Preparing Source Documents and their templates11) Coordinate and schedule subject's regular follow-up Visit and Procedures. preventing lost to follow-up & missed visits. Maintaining regular contact With Subject Telephonically12) Manage Clinical Trial Materials (CTM ). accountability, distribution & logistics at site13) Filling the case reports forms and Electronic case report forms and resolving all data queries within timelines.14) Reporting and coordinating all Adverse Events & Serious Adverse Events according to their timelines.15) Filling up and maintaining trial related logs like drug dispensing logs, subject logs. investigational Product t Logs, temperature logs. Etc. 16) Maintaining Calibration records of Instrument used for the trials.17) Preparing Site for monitoring & audit visits. Coordinate close out visit & archival at site.18) Communicating all protocol-related issues problems to the appropriate management staff including but not limited to questions regarding the conduct of clinical trials. Concerns regarding possible serious adverse events or subject compliance.19) Co ordinate central lab logistics & sample flow. Review lab data & communicate abnormal values to the primary care provider(if appropriate) & investigator.20) Co ordinate subject reimbursements.21) Performing all the above activities i