What does a clinical research associate do?
A Clinical Research Associate (CRA) ensures that every clinical trial follows the standard operating procedures and Good Clinical Practice (GCP) guidelines.
The primary roles and responsibilities of clinical research associates include conducting regular site visits and managing data accumulated during trials. They also review study progress, identify and mitigate trial risks and report any issues to the sponsor.
CRAs play a crucial role in protecting the study participants' safety and well-being. They oversee that generated data is reliable, which is later used to develop new therapies and improve patient outcomes. Without CRAs, clinical trials would be at risk of not meeting regulatory requirements and the validity and reliability of the data collected would be questionable.
In this field, the ‘Lead Clinical Research Associate’ and ‘Clinical Research Manager’ hold senior-level positions. S/he is also referred to as ‘clinical monitor’ or ‘trial monitor’.
Do note that clinical research associates (CRAs) differ from clinical research coordinators (CRCs). While CRAs ensure regulatory oversight at the site of medical trials, the CRCs are responsible for carrying out and managing clinical trials.
Job Description: Template
We seek a resilient and meticulous clinical research associate to our team at [Company ABC].
The ideal candidate will be well-versed in clinical trial management. They are rigorous, detail-oriented, and precise in their analysis reports.
You will be required to manage the data collected during trials, oversee trial sites, and conduct regular site visits to monitor the progress. You will also collaborate with the sponsors at trial sites and ensure the tests are conducted ethically while adhering to applicable regulations and guidelines.
As a part of our workforce, you can avail numerous health and wellness benefits alongside flexible work arrangements. We offer a competitive salary package and professional development opportunities to ensure a bright career path for you in the medical field.
Objectives of this role
- Ensuring compliance with protocols, standard operating procedures, and Good Clinical Practice (GCP) guidelines.
- Conducting regular site visits to monitor trial activities and data collection.
- Reviewing and analysing clinical trial data for accuracy and completeness.
- Developing and maintaining study timelines and budgets.
- Providing training to study staff on study protocols and GCP guidelines.
Your tasks
- Reviewing and approving study-related documents, such as informed consent forms.
- Conducting source data verification and ensuring data quality.
- Managing trial supplies and drug accountability.
- Serving as a liaison between study sites, sponsors and regulatory agencies.
Required skills and qualifications
- BA bachelor's degree in pharmacy or nursing.
- At least 1 year of experience in a similar role.
- Knowledge of regulatory requirements and guidelines, such as Good Clinical Practice (GCP) and International Council for Harmonization (ICH).
- Certification in clinical research, such as the Association of Clinical Research Professionals (ACRP) certification.
- Knowledge of clinical trial data management systems and electronic data capture.
- Experience with site selection, initiation, management, and monitoring activities.
- Strong attention to detail and accuracy in data management.
Preferred skills and qualifications
- Understanding of pharmacology and drug development processes.
- Working knowledge of medical terminology and anatomy.
- Excellent project management and leadership skills with attention to detail.
- Ability to work collaboratively with study teams and cross-functional departments.
