Clinical Trials

2 days ago

Mumbai, India Acme Services Private Limited Full time
Key Responsibilities:
Preparation of study specific documents and study tools.
Lead the assigned studies and Co-ordination with the CRA/ Sr. CRA/ CTA for day to day startup activities and providing the updates to Project Manager.
Performing Site Selection Visits for assigned study and prepare site selection visit report.
Review of dossier for EC submissions.
Organize and coordinate Investigator's meeting.
Collaborate with Project Manager (PM), other CRA's and CTA's to communicate trial logistics prior to SIV.
Ensure smooth operational execution of allocated clinical trial and proper follow up with the sites and other CRA's as a project lead for all activities.
Implement site management including monitoring visits, site compliance assessment, drug supply management, etc.
Perform Site Co-Monitoring Visits with CRAs and trainings to site staff for assigned study. Verify site compliance for all the trial procedures and documentations and completeness of CRF and source documents.
Assist in expanding investigator pool.
Perform budget negotiations at study and site level and management of the trial budget(s) and maintenance of the accounts.
Participate in internal team meetings and lead the project meeting for assigned projects and provides inputs and updates on regular basis.
Taking updates from other CRA's for assigned study as a project lead and providing the compiled updates in timely manners to Project Manager.
Assess the site organization on regular basis in order to secure the quality and support the site
Document management: Review and update the study files as per study requirements.
Collate and summarize questions/issues regarding protocol logistics and monitoring specifics and seek resolution with the Project Manager.
Collaborate with the Project Manager to ensure recruitment and execute contingency plans, as needed.
Manage all site and vendor related issues with supervision from the Project Manager.
Act as a mentor to other CRA's for purposes of on-site training and training on trial processes.
May provide backup cover for Project Manager at trial level.
Performs any other duties as assigned by management.

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