Job Description

• Lead the assigned studies and co-ordination with the CRA/ Sr

• CRA/ CTA for day to day study activities and providing the updates to Head Clinical Operation
• Facilitate the preparation and collection of study and site level documents
• Preparation of study specific documents and tools
• Review of study documents (Protocol, ICF, CRF, subject diary, clinical study report etc) Contribute to the identification of new sites for clinical trial; analyze site capability and performing site feasibility along with CRA s for assigned study
• Performing Site Selection Visits for assigned study as per the Protocol, Macleods SOP s, ICH-GCP and applicable regulatory requirements and prepare site selection visit report
• Review of dossier for Ethics Committee and regulatory submissions
• Organize and coordinate Investigator s meeting
• Accompany with QA for vendor qualification and evaluation audit
• Assist site for regulatory inspection
• Ensure translation of ICF and subject diary for study
• Collaborate with Head Clinical Operation, CRA s, CTA s and vendors to communicate trial logistics prior to SIV and during study Performing Site Initiation Visits and trainings to site staff for assigned study as per the Protocol, Macleods SOPs, ICH-GCP and as per applicable regulatory requirements and prepare site initiation visit report
• Ensure smooth operational execution of allocated clinical trial and proper follow up with the sites and CRA s as a project lead for all activities
• Implement complete site management including monitoring visits, site compliance assessment, drug supply management, etc to ensure compliance with protocol, Macleods SOPs, GCP and as per applicable Regulatory requirements
• Perform Site Monitoring Visits and trainings to site staff for assigned study as per the Protocol, Macleods SOPs, ICH-GCP and as per applicable regulatory requirements and prepare site monitoring visit report
• Verify site compliance for all the trial procedures, documentations and completeness of CRF and source documents
• Ensure site and project activities in line with milestones (ie start-up, recruitment, closeout, etc)
• Identify problems at sites; resolve issues and escalate as appropriate with consultation with HCO and HCT
• Review and manage data at site; resolve technical and content queries on a continuous basis in order to achieve timely study completion
• Perform close-out visits for assigned study as per the Protocol, Macleods SOPs, ICH-GCP and regulatory requirements and prepare site monitoring visit report
• Assist in expanding investigator data base across different therapy
• 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 Head Clinical Operation and provide any other data as per requirement
• Perform follow-up with vendor for for study related activities
• 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
• Reconciliation and Management of IP and other clinical trial supplies at study and site level
• Provide inputs in preparation monitoring strategies and planning of the trial activities
• Ensure that all the assigned CRAs for particular study are provided with all tools necessary to conduct the trial and well trained as per study requirement
• Collate and summarize queries regarding protocol, study management, logistics and monitoring specifics and seek resolution with the Head Clinical Operation
• Collaborate with the Head Clinical Operation to ensure recruitment and execute contingency plans, as needed
• Manage all site and vendor related queries with supervision from the Head Clinical Operation
• Act as a mentor to CRA s for purposes of on-site training and in-house training on trial processes, as assigned
• Preparation, Review, training and Maintenance of SOPs/EOPs/guidelines for clinical trial department to ensure adherence to GCP, applicable regulatory requirement and administrative requirements
• Training to new recruits in clinical trial department Performs any other duties as assigned by management

More Info

Education