The Sr. CRA/Regional CRA Manager is responsible for the oversight of assigned clinical Field Operations staff and activities ensuring that studies are executed, conducted and completed, in accordance with corporate goals and objectives, applicable regulations and Standard Operating Procedures (SOPs). The Senior CRA Manager functions with minimal supervision, collaborating with inter- and intra-company resources to ensure quality performance and that project timelines and needs are being met.
POSITION SUMMARY:

In-house position, up to 50% travel
The Clinical Research Associate (CRA) Regional Manager collaborates directly with the Study Manager(s) to ensure the CRAs are ensuring adherence to the currently approved protocol, adherence to all FDA regulations and ICH guidelines and any other applicable regulatory agency for their assigned sites.  The CRA Regional Manager reports directly to the Associate Director/Director, Clinical Field Operations.   The CRA Regional Manager is expected to operate independently with minimal supervision.  Travel is anticipated to be up to 50%.

RESPONSIBILIITES:
Recruit, manage, motivate, train, and develop assigned Clinical Field Operation staff, includes discipline and termination if applicable
Resource clinical studies by assigning CRAs based upon needs of the clinical study teams
To assure adequate protection of the rights of human subjects and the safety of all subjects involved in client sponsored clinical trials
To ensure Clinical Investigators are following the approved clinical trial and adhering to all FDA regulations and ICH guidelines
To ensure the overall quality, integrity and validity of the data collected in sponsored clinical trials submitted to the Food and Drug Administration (FDA) and other global health authorities
Ensure direct reports are providing timely and adequate documentation of the status and findings from monitoring visit using the applicable reports
Attend applicable clinical team meetings to represent the CRA's perspective and how identified issues, concerns or success may impact the success of current studies
Periodically review SOPs, WPGs and associated tools for applicability and suggest appropriate modifications.
Review and contribute to the development of applicable Monitoring Plans
Build and maintain long-term professional relationships with Clinical Investigators
Support staff with resolution of significant site issues
Support staff with resolution of findings from Clinical Quality Audits
Contribute to continuous improvement efforts for Clinical Field Operations
Participate in the development of policies, guidelines and SOPs for Clinical Field Operations and Clinical Operations
Track, measure and report the status of project milestones for assigned staff
Education/Experience:
BS Degree with 5 years of Monitoring experience on complex studies, 2 years of CRA Management experience.

TO APPLY: Please email resume to Ginger Mauk at gmauk@greenkeyllc.com. Please indicate "CRA Manager" on the subject heading of email.