ProClinical has a brilliant opportunity for an in-house Clinical Research Associate to be based in Jacksonville, FL. This job will be with one of the largest workforce management solutions companies in the world who specialise in multiple scientific and engineering sectors. The In-House CRA is based in the client's facility and will provide clinical research support and assistance in overseeing the conduct of clinical trials.
- Work to ensure that trials are adhere to study protocols, applicable SOPs, FDA regulations, International Conference for Harmonization (ICH) / Good Clinical Practices (GCP) guidelines, and government regulations.
- Evaluate, monitor, and document study results.
- Exercise good clinical judgment and demonstrate professional conduct when interacting with investigational site personnel and sponsor representatives.
- Monitor Clinical Research Organizations (CROs) and study management of multiple sites.
- Additional duties include: document retrieval, archival, informed consent release forms, amendments, etc.
- Responsible for the management of designated clinical trials including investigator recruitment and selection, analysis of potential patient recruitment, preparation of trial related documentation (protocols, case report forms, investigators brochures, consent documents, letters of agreement, confidentiality agreements), organizing Ethics committee submissions with follow through to ensure successful outcome.
- Ensure procedures are in place for appropriate optimization of patients into the clinical trial.
- Planning the requirements for clinical trial material (CTM), ordering CTM, setting up and monitoring the systems whereby the CRA can ship CTM to the investigator, maintaining procedures to account for the CTM, checking the expiration of CTM, and requesting extensions if necessary.
- Approximately 15% local on-site monitoring.
Skills and Requirements:
- Bachelor's degree required
- 1-3 years combined experience with at least one of the following:
Clinical Research Coordinator (site-level Study Coordinator) experience is required in lieu of CRA experienceOn-site monitoring experience is preferred but not requiredElectronic Data Capture (EDC) experience required (non-discriminatory)Excellent oral and written communication skillsWillingness to travel up to 15% (as-needed basis, not continuous basis) in Southeast US for intermittent monitoring
- Medical device research experience
- In-house pharma CRA experience (strictly Regional CRA experience will be considered)
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 Mary Jacobs on +1 267 477 4800 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.