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Senior CRA

3 months ago

mumbai, India Acme Services Private Limited Full time

Key Responsibilities:

Facilitate the preparation and collection of study and site level documents.
Identification of new sites for clinical trials and performing sit feasibility for assigned study.
Performing Site Selection Visits for assigned study.
Organize and coordinate the Investigator's meeting.
Preparing site and tracking of all the activities for site initiation and to ensure that all necessary site tools are circulated to sites.
Collaborate with Clinical Trial Manager (CTM) and CTA to communicate trial logistics.
Performing Site Initiation Visits and training to site staff for assigned study.
Ensure smooth operational execution of allocated clinical trials and proper follow up with the sites for all activities.
Ensure site activities in line with milestones.
Review and manage data at site; resolve technical and content issues on a continuous basis.
Perform close-out visits for assigned study as per requirements.
Act as the main line of communication between Macleods and sites.
Participate in internal team meetings and provide inputs and updates on a regular basis.
Assess the site organization on regular basis in order to secure the quality and support the site
Document management: Prepare the study files (TMF, SMF and ISF) and review and update them on an ongoing basis as per study requirements.
Reconciliation and Management of IP and other clinical trial supplies.
Preparation, Review and Maintenance of SOPs for clinical trial department to ensure adherence to GCP, regulatory requirement and administrative requirements.