Here is a chance to join one of the most globally known pharmaceutical organisations, who are looking to hire a In-House Clinical Research Associate II based in Jacksonville Florida. This job is at a top 10 pharmaceutical company that works across a range of industries from medical devices to pharmaceutical and consumer goods, operating in over 60 countries.
The In-House CRA II 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 co-monitoring
- Bachelor's degree required
- 3-5 years combined experience with at least one of the following:
- Medical device experience
- In-house pharma CRA experience (strictly Regional CRA experience will be considered)
- 2-3 years CRA experience will be considered
- On-site monitoring experience is preferred but not required
- Candidates transitioning directly from a Clinical Research Coordinator role will NOT be considered
- Electronic Data Capture (EDC) experience required (non-discriminatory)
- Excellent oral and written communication skills
- Willingness to travel up to 25% (on an as-needed, not continuous basis) in Southeast US for occasional co-monitoring
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 Christopher Frank on +1 267 405 6996 or upload your CV 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.