Senior Clinical Research Associate
Not Disclosed•Full-TimeOn-site
location_on328, West Ardenwood Drive, Ardenwood, Mid City, Baton Rouge, East Baton Rouge Parish, Louisiana, 70806, United States
About the Role
The Senior Clinical Research Associate (Sr. CRA) serves as a critical guardian of patient safety and study integrity, managing the full lifecycle of assigned clinical trial sites from activation through database lock. This role exists to ensure that clinical trials are executed with the highest standards of quality, adhering strictly to Good Clinical Practices (GCP), applicable laws, and the Sponsor's internal standards.
As the primary point of contact for investigator sites, the Sr. CRA fosters strong relationships with site staff and healthcare professionals. The day-to-day involves a dynamic blend of onsite and remote monitoring, where you will oversee investigational product handling, resolve protocol-related issues, and drive corrective actions for any quality events. You will partner closely with the Site Care Partner (SCP) to coach site personnel, support recruitment initiatives, and ensure that data is accurate and timely. Whether attending virtual investigator meetings or traveling to sites to conduct audits, your goal is to safeguard the quality of the investigator site while enhancing the company's reputation among external stakeholders.
Work location
Work model: On-site
328, West Ardenwood Drive, Ardenwood, Mid City, Baton Rouge, East Baton Rouge Parish, Louisiana, 70806, United States
Baton Rouge, Louisiana
Key Responsibilities
- check_circleManage site monitoring and close-out activities to ensure patient safety and study quality
- check_circleServe as primary point of contact for investigator sites to facilitate effective trial delivery
- check_circleResolve protocol-related issues and develop corrective actions with site personnel
- check_circleProvide protocol training and coaching to site personnel to ensure ongoing compliance
- check_circleConduct onsite and remote monitoring in accordance with Study Monitoring Plans and SOPs
- check_circleMonitor adverse events and collaborate with Drug Safety Unit for SAE reporting resolution
- check_circleDrive audit observation remediation and develop corrective action plans
- check_circleSupport database release and prepare investigator site close-out plans
- check_circleOversee investigational product handling, storage, and destruction at investigator sites
Requirements
- verifiedBachelor's degree in life sciences or professional degree in life sciences
- verifiedMinimum 3 years relevant experience in clinical research site monitoring
- verifiedValid driver's license and passport required
- verifiedFluent in English and native language(s) of the country worked in
Nice to Have
Preferred therapeutic experience in Oncology, Vaccines, Internal Medicine, or Infectious Diseases.
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Skills, education and keywords
Skills: Clinical Trial Methodologies, Ich/gcp, Food And Drug Administration, Oncology, Vaccines, Internal Medicine, Infectious Diseases, English, Valid Driver's License, Passport.
Education: Bachelor's degree in life sciences or equivalent.
Frequently asked questions about Senior Clinical Research Associate at Parexel
What does a Senior Clinical Research Associate at Parexel do?expand_more
A Senior Clinical Research Associate at Parexel is responsible for the following: Manage site monitoring and close-out activities to ensure patient safety and study quality; Serve as primary point of contact for investigator sites to facilitate effective trial delivery; Resolve protocol-related issues and develop corrective actions with site personnel; and Provide protocol training and coaching to site personnel to ensure ongoing compliance.
What are the requirements for this Senior Clinical Research Associate role?expand_more
Parexel is looking for candidates who meet the following requirements: Bachelor's degree in life sciences or professional degree in life sciences; Minimum 3 years relevant experience in clinical research site monitoring; Valid driver's license and passport required; and Fluent in English and native language(s) of the country worked in.
Where is the Senior Clinical Research Associate role at Parexel located?expand_more
Senior Clinical Research Associate at Parexel is based in 328, West Ardenwood Drive, Ardenwood, Mid City, Baton Rouge, East Baton Rouge Parish, Louisiana, 70806, United States. This is a on-site role.
Is this Senior Clinical Research Associate job remote, hybrid, or on-site?expand_more
Parexel has listed this Senior Clinical Research Associate role as on-site.
How much experience is required for this Senior Clinical Research Associate role?expand_more
Senior Clinical Research Associate at Parexel typically requires 3+ years of relevant experience at the senior level.
What skills do you need for the Senior Clinical Research Associate role at Parexel?expand_more
Key skills for Senior Clinical Research Associate at Parexel include Clinical Trial Methodologies; Ich/gcp; Food And Drug Administration; Oncology; Vaccines; Internal Medicine; Infectious Diseases; and English.
What education is required for Senior Clinical Research Associate at Parexel?expand_more
Educational requirements for this role: Bachelor's degree in life sciences or equivalent.
What category does the Senior Clinical Research Associate role belong to?expand_more
Senior Clinical Research Associate at Parexel is part of the scientific & qa job category on Recrutus.