CRA Manager

Veeda CR; Ahmedabad District; On-site; INR 600,000 - 900,000; Full time

Job summary

Veeda CRR Ahmedabad seeks an experienced On-Site Monitoring professional to ensure clinical trials progress in line with ICH-GCP, SOPs and contract specifications, while maintaining budget and schedule. The role involves site initiation, monitoring visits, data checks and regulatory filing, with strong collaboration across project teams.

The incumbent will train and supervise CRAs, oversee payments and budgets, screen new sites, and track patient/site/PK/SAE data to minimize data loss while

Responsibilities

• Ensure project progresses per quality standards, SOPs, ICH-GCP and contract specs within budget and schedule.
• Interact with project manager to provide updates, flag issues, share information and instructions.
• Implement enrollment and recruitment strategies.
• Provide guidance, oversight, and feedback to the CRA for scope, SOPs, timelines and budget.
• Provide protocol-specific training to CRAs including CRF conventions and SOPs.
• Supervise CRA activities, schedule monitoring visits, review visit reports for accuracy, and assist monitors.
• Review and approve payments to study sites and vendors; prepare budget forecasts and reports.
• Identify and screen new sites and principal investigators; build a database of potential PIs/sites.
• Track patient, site, IMP, PK sample, SAE monitoring and overall project tracking.
• Liaise with study sites and core team (data managers, statisticians) to ensure up-to-date follow-up data and minimize data loss.
• Assist in oversight of documentation collection and filing into the Trial Master File.
• Ensure timely investigator site visits and participate in investigator recruitment and site evaluations.
• Conduct co-monitoring visits with CRAs to ensure quality and SOP/GCP compliance.
• Assist and guide CRAs in conducting pre-study, initiation, interim, and closeout visits as required.
• Mentor and motivate Clinical Research Associates; provide ongoing training to improve performance.
• Ensure CRAs meet quality/performance metrics and develop tracking tools to measure this.
• Review visits, reports and follow-ups; approve expense claims and travel requests as per procedures.
• Identify development plans for CRAs and provide feedback to Line Manager on performance.

Job description

Role & responsibilities

• Ensure the project is progressing according to quality standards, SOPs, ICH-GCP and/or other guidelines to fulfill local regulations and is completed within budget, as per schedule and according to contract specifications.


• Interacting with project manager through formal and informal communications, including providing updates, identifying issues, sharing of information and instructions


• Implementation of enrollment and recruitment strategies.


• Provides guidance, oversight, and feedback to the CRA to ensure adherence to project scope, SOPs, timelines, and budget requirements.


• Provide protocol specific training to the CRA's including CRF conventions, study procedures and SOPs.


• Supervise activities of the CRA's including the scheduling of monitoring visits, other activities associated with the project (e.g., review of visit reports for completeness and accuracy, assisting monitors with problem sites, etc.), and time accountability for the project.


• Review and approve payments to the study site and vendors and prepare budget forecasts and reports for assigned projects.


• Identify and Screen new sites and PIs and Create Data Base of New potential PIs and sites.


• Overall tracking of project like patient tracking, site visit tracking, IMP tracking, PK sample tracking, SAE tracking etc.


• Regularly liaising with study sites and other members of the core team (data managers, statisticians) to ensure follow-up visits data are kept up-to-date, accurately completed and that loss of patient data is kept to a minimum.

On‑Site Monitoring, Communication & Documentation

• Assistance in oversight of documentation collection and filing into the Trial Master File.


• Ensures appropriate and timely investigator site visits.


• Participates in the investigator recruitment process. Performs site evaluation visits of potential investigators. Evaluates the capability of the site to successfully manage and conduct the clinical study


• Conduct co-monitoring visits with CRA's to ensure quality and compliance with SOPs, GCPs and project requirements

Human Resource Management

• Assist and guide CRA's in conducting pre-study, initiation, interim and closeout monitoring visits as required


• Effectively manage, motivate and mentor Clinical Research Associates.


• Ensure all necessary training is provided to improve job performance, knowledge of junior staff and make sure all day to day management support is provided (accompanied and training visits).


• Ensure Clinical Research Associates (CRA) meet quality/performance metrics for study and production of project metrics as required and devise specific tracking tools to ensure this is achieved.


• Review and tracking of visits, reports and follow up letters together with review of all significant communication with sites.


• Review and approval of expense claims, travel allowances, travel request forms, and vacation requests according to the respective company procedures.


• Identify and implement development plans for CRA and provide continual feedback to Line Manager on CRA performance.


• Performs additional duties as assigned