A Senior Clinical Research Associate (CRA) plays a critical role in the planning and execution of clinical trials to test medical treatments and drugs. Their primary responsibilities involve overseeing and managing clinical trials at medical facilities and research sites, ensuring that activities adhere to established protocols, guidelines, and regulations. Let's delve into the key duties and tasks associated with this role:
Project Planning and Budgeting:
Develop detailed project plans and budgets for clinical trial protocols.
Oversee and track progress to ensure adherence to timelines.
Training and Support:
Lead training initiatives and onboard research staff at trial sites.
Provide ongoing support and education to site personnel.
Drug Supply Management:
Create master drug supply forecasts.
Manage distribution logistics to trial locations.
Monitoring and Troubleshooting:
Monitor trial timelines, budgets, drug supply chains, data quality, and site performance.
Identify and troubleshoot any issues that arise during the trial.
Reporting and Documentation:
Prepare reports on trial progress and findings.
Submit necessary documentation to regulatory agencies.
Ensure ethics committee approval for trial activities.
Leadership and Coordination:
Supervise teams of CRAs and other site personnel involved in trials.
Collaborate with clinical operations managers or directors.
Coordinate activities across research sites, often requiring frequent travel.
Qualifications and Requirements:
Bachelor's degree in science/health (Master's degree or RN preferred).
Relevant experience in clinical trials or research.
Detail-oriented with strong leadership abilities.
Certification from associations like ACRP (for positions in the USA).
What you'll need to succeed
What you'll get in return
What you need to do now
If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.
If this job isn't quite right for you, but you are looking for a new position, please contact us for a confidential discussion on your career.
