CRA l/ll (thermofisher)

Roles and Responsibilities

What You’ll Do:

• Manage client relationships and serve as a primary point of contact for assigned clinical trials

• Conduct on-site monitoring visits in accordance with client SOPs and project-specific requirements

• Perform risk-based monitoring activities, including source data verification and source document review

• work on client systems including CTMS, EDC, IWRS, eTMF etc.

• Support in maintaining the country metrics

• Ensure compliance with Good Clinical Practice (GCP), ICH guidelines, and applicable regulatory requirements

• Collaborate with clinical sites to resolve issues and maintain study integrity

• Prepare and submit accurate, timely monitoring reports and follow-up letters

• Participate in client meetings and provide regular updates on study progress

• Routinely complete all assigned CRG, Client and project specific trainings

• Support in site audits/ inspections and assist in the development and implementation of corrective and preventive actions (CAPAs)

• Takes ownership for follow up on identified risks/issues through to successful resolution.

• Contribute to the continuous improvement of monitoring processes and guidelines

• Travel to clinical sites as per the monitoring plan (up to 60-75% travel may be necessary)

• Maintains & completes administrative tasks such as expense reports and timesheets in a timely manner.
  
  Education and Experience Requirements:

• Postgraduate degree in Life Sciences or a related field

• Minimum of 1-1.5 years of on-site monitoring experience in clinical trials (Mandate)

• Demonstrated knowledge of ICH GCP guidelines and applicable regulatory requirements

• Experience working in an FSP model is preferred (not mandatory)

• Valid Drivers' license where applicable

In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills and Abilities:

• Strong client management skills with the ability to build and maintain positive relationships

• Excellent knowledge of clinical research processes and medical terminology

• Proficiency in following and interpreting client-specific SOPs

• Strong attention to detail and ability to maintain accurate records

• Excellent verbal and written communication skills

• Ability to work independently and as part of a team

• Proficient in using clinical trial management systems (CTMS) and electronic data capture (EDC) systems

• Ability to work on multiple projects simultaneously and prioritize optimally

• Problem-solving skills and the ability to make sound judgments

• Flexibility to adapt to changing client needs and project requirements

• Ability to perform monitoring visits as per Risk Based Quality Management (RBQM) concepts and processes

• Ability to work in a team or independently as the need arises

• Digital literacy and proven knowledge of Microsoft Office and the ability to learn appropriate software

• Good English language and grammar skills