CTM- Clinical Trial Manager

A bay area based company is seeking a Sr CRA/ CTM to assist with a number of their phase I-III clinical trials.

The ideal candidate will:

- Use knowledge of FDA regulations and ICH guidelines to ensure compliance with both during clinical trial conduct.
- Have had experience as clinical operations co-lead/lead on a significant Phase II or Phase III program.
- Can independently designs study related documents including but not limited to: clinical protocols, case report forms, site study manuals and project tools, monitoring plans, tracking tools, informed consent forms.
- Has experience leading study management team meetings and teleconferences with study vendors.
- Manage study-specific CROs and vendors and contract CRAs as appropriate.
- Perform monitoring of sites as required by needs of project with minimal guidance or supervision.

Requirements include:

- BA/BS in science-related field.
- 5+ years years work experience as a CRA or CRA/CTM combination of relevant related work experience.
- Excellent written and verbal communication skills required. Exceptional interpersonal skills with demonstrated successful team participation.
- Demonstrated thorough understanding of FDA regulations and GCP.

This is am immediately available position. All interested parties may submit their resume to e.laidlaw(@)realstaffing.com or call 415.796.8000.
To find out more about Real please visit www.realstaffing.com