A Clinical Research Associate (CRA) is responsible for coordinating and supervising clinical trials. They act as a liaison between the clinical trial sponsor’s Contract Research Organisation (CRO) and the clinical trial site, which means that they may be involved with multiple trials at the same time.
Clinical Research Associates don’t have any personal contact with the trial participants but they have daily contact with the clinical trial staff at the study sites, which means that there can be significant travelling involved. CRAs are typically employed by pharmaceutical companies, contract research organisations (CROs), and hospital academic departments. The role of a Clinical Research Associate is integral to the successful conduct of a clinical trial.
Responsibilities of a CRA
The daily responsibilities of a Clinical Research Associate depends on the clinical trial(s) they are overseeing, but generally the roles of a CRA include:
- Selecting a clinical trial site: the Clinical Research Associate plays a crucial role in selecting the clinical trial site by evaluating site applications and by having potential sites complete and submit a feasibility questionnaire.
- Assessing potential site applications: When the potential site list has been narrowed down, the Clinical Research Associate inspects each site to confirm the validity of the feasibility study, observe the equipment and meet with the staff.
- Inspecting sites: After visiting the potential sites, the Clinical Research Associate creates a report of their visit for the clinical trial sponsor and recommends the next steps to take.
- Confirming that the site knows the trial protocols: Once a site has been chosen, the Clinical Research Associate needs to ensure that the site knows what the sponsor’s required protocol is and that their equipment is up to standard.
- Site visits throughout trial: The Clinical Research Associate carries out site visits throughout the trial to ensure that all the protocols are being followed and that the data is being efficiently collected. Depending on the clinical trial, sometimes a virtual visit is enough and enables the CRA to still be able to review paperwork online.
- Acts as a liaison throughout the trial: The Clinical Research Associate acts as a liaison throughout the trial, developing and maintaining a positive relationship with the various clinical trial staff. The CRA must make themselves accessible to assist with any queries that the staff have and to help the clinical trial progress smoothly.
- Closeout visit and verification process: When a clinical trial concludes, the Clinical Research Associate carries out a closeout visit where they verify that all the necessary paperwork has been completed and that all the obligations have been met on both sides. The verification process includes ensuring that the investigational product has been destroyed or returned, filing all documentation correctly, and compiling all the crucial information needed to complete the final report for the clinical trial sponsor.
Skills and Abilities Needed for a CRA Role
A Clinical Research Associate position is a multifaceted one which requires the use of many different skills for them to be successful in their role.
- Organisation and an eye for detail: Clinical Research Associates oversee the documentation, filing and storage of important documents meaning that they need to be organised and have an efficient system in place.
- Identifying and monitoring ethical issues: Clinical Research Associates need to have a thorough understanding of the ethical issues that surround a clinical trial, and be able to stand up to and acknowledge any ethical violations.
- Implementing Good Clinical Practices (GCP) successfully: a Clinical Research Associate needs to uphold and practice Good Clinical Practice (GCP) standards throughout the duration of the trial by recognising and enforcing these practices in a clinical environment. This is one of the most important parts of the CRA role.
- Knowledge of randomised controlled trials: Clinical Research Associates need to have a good understanding of the ins and outs of randomisation, including their principles, methodology and procedures.
- Knowledge of federal and state guidelines: Clinical Research Associates need to have a clear understanding of all the federal and state regulations pertaining to the conduct of clinical trials.
- Computer skills: Clinical Research Associates need to be able to use software applications for statistical analysis.
- Understanding statistical data: Clinical Research Associates need to be able to collect, edit and validate statistical data.
- Understanding of Serious Adverse Events: Clinical Research Associates need to have a good understanding of an adverse event investigation, including the reporting procedures and standards.
- Good understanding of CROs and laboratories: Clinical Research Associates need to know and understand the infrastructure and operational characteristics of Contract Research
Organisations (CROs) and centralised clinical laboratories.
- Be aware of trends in clinical trials: Clinical Research Associates should have a good understanding of current and emerging trends in clinical trials monitoring.
- Good understanding of how grants work: Clinical Research Associates should know how grant writing and reporting works.
- Good communication skills: Clinical Research Associates should feel confident enough to communicate professionally with people from all levels within a complex clinical research environment.
- Supportive of clinical trial staff: Clinical Research Associates should be able to provide technical advice, guidance and support to the clinical trial staff.
- Ability to train employees: Clinical Research Associates should feel comfortable enough to supervise and train employees, and help them organise, prioritize and schedule their tasks in an efficient manner.
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