Sr. Clinical Research Associate
Proclinical is currently recruiting for a Senior Clinical Research Associate for a research institute located in Plainsboro, NJ. Successful candidate will monitor the progress of clinical studies at investigative sites and ensure clinical trials are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), ICH-GCP, and all applicable regulatory requirements.
- Monitor the progress of clinical studies at investigative sites.
- Ensure clinical trials are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), ICH-GCP, and all applicable regulatory requirements.
- Responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files conduct of pre-study and initiation visits.
- Liaise with vendors; and other duties, as assigned.
- Workload is variable and travel may be extensive (at times); however, when practical, we will keep you as close to home as possible.
Skills and Requirements:
- Bachelor's degree preferably in biological or life sciences curriculum.
- 4-7 years as an onsite CRA specifically involving oncology monitoring. This could include 2-4 years' work experience as an oncology nurse or study coordinator.
- To qualify you must have demonstrative CRA experience working directly for a CRO or pharmaceutical/biotech company.
- Proven knowledge of ICH-GCP and privacy regulations/guidelines.
- Experience using commercial EDC systems (MediData RAVE, Inform, DATATRAK, etc.)
- Working knowledge of how to use site-based electronic medical records (EMR) systems
- The ability to work independently, handle multiple tasks simultaneously, prioritize and work under tight deadlines.
- Excellent verbal and written communication skills are essential for interaction with both internal and external clients.
- Valid driver's license.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Miles Tobin at (+1) 617-545-5922 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.