CRA II

Purpose: ***COMPETETIVE RELOCATION PACKAGE AVAILABLE****

A local medical device company is currently looking to add several in-house CRA's to join their ever growing company.

Job Description:

- Manage and monitor all aspects of clinical study implementation in accordance with FDA regulations and ICH and GCP guidelines for clinical research studies and SOP's.
- Assume on-site and in-house monitoring responsibilities as needed and required by GCP.
- Planning and creation of presentations of clinical research study information.
- Contribute to clinical research study design, quality assurance, data management, and reporting activities.
- Identifies and evaluates issues related to the project and implements resolutions.
- Provide input on departmental decisions related to process and procedures.
- Participates in design and development of CRF's.
- Participates in investigator recruitment and provide final recommendation.
- 10% or less in travel.

Qualifications:

- 2 years of full cycle work.
- BA/BS with 4-6 years experience as clinical research associate (or equivalent) in a related device or pharmaceutical industry.
- 3+ years experience as a study monitor in a CRO.
- CRA certification a plus; Knowledge and understanding of current regulatory issues related to Phase I-IV clinical research; Knowledge of project management tools and practices.
- Excellent communication and organizational skills.
- Comprehensive knowledge of Microsoft Word, Excel, and PowerPoint.

Specialized Training:

Clinical monitoring, FDA, GCP, and ICH.

Please contact Phil Baker (585.350.2714) or email resume