Senior Clinical Research Associate
Not Disclosed•Full-TimeOn-site
location_onBeacon Street Mall, Beacon Hill, Boston, Suffolk County, Massachusetts, 02108, 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 to Good Clinical Practices (GCP), applicable laws, and the Sponsor's rigorous 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 coach site personnel on protocol compliance, resolve complex operational issues, and drive recruitment initiatives. You will act as a bridge between the study team, vendors, and the investigator, ensuring seamless information flow and timely resolution of data queries or adverse events. Whether facilitating virtual meetings or traveling to sites, your goal is to enhance the company's reputation while safeguarding the quality of data and the safety of patients.
Work location
Work model: On-site
Beacon Street Mall, Beacon Hill, Boston, Suffolk County, Massachusetts, 02108, United States
Boston, Massachusetts
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_circleMonitor adverse events and collaborate with Drug Safety Unit to resolve SAE reports
- 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_circleDrive audit observation remediation and develop corrective action plans
- check_circleSubmit required documentation including TMF records, site reports, and protocol deviations
- check_circleSupport recruitment initiatives and provide enrollment assistance to investigator sites
- check_circleEnsure proper handling and accounting of investigational products at assigned 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 they will work in
- verifiedExtensive knowledge of clinical trial methodologies, ICH/GCP, FDA and local country regulations
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
Day-to-day, the Senior Clinical Research Associate at Parexel will 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 monitor adverse events and collaborate with drug safety unit to resolve sae reports.
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; Fluent in English and native language(s) of the country they will work in; and Extensive knowledge of clinical trial methodologies, ICH/GCP, FDA and local country regulations.
Where is the Senior Clinical Research Associate role at Parexel located?expand_more
Senior Clinical Research Associate at Parexel is based in Beacon Street Mall, Beacon Hill, Boston, Suffolk County, Massachusetts, 02108, 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.