CRA Manager

Role & responsibilities

Off-site

• 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

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

• 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