CRA (Real Life Sciences)

Clinical Research Universe Featured Jobs

Posted: June 6, 2016

Job ID: 156

Job Summary

Term: Full-Time
Job Roles: Clinical Trial Monitoring
Required Education: BS degree in a health related science or equivalent
Required Experience: 2 years

Job Description

The CRA will report to the Assistant Director of Clinical and Regulatory Operations and is responsible for assisting with the design, administration, and monitoring of clinical trials; monitoring and managing clinical data from collection through locked database; and ensuring compliance with clinical protocols, their objectives, and ICH and GCP guidelines.
Responsibilities and Duties:
• Assist with the design of clinical studies.
• Coordinate investigational site startup activities including, but not limited to, the creation, preparation, and shipment of documentation (e.g., ICFs, CRFs, study manuals, study binders, etc.), organizing Ethics Committee submissions, facilitating completion of clinical study agreements and budgets, and shipment of clinical supplies.
• Work closely with the Clinical Trial Manager for each clinical study to manage contract vendors (e.g., CRAs) and Clinical Research Organization (CROs) to ensure all monitoring activities are conducted according to the Clinical Monitoring plan and relevant SOPs.
• Coordinate and maintain relevant tracking systems subject screening, enrollment, study visits, data entry, query resolution, etc.
• Review clinical databases on a real time basis to identify/resolve data entry issues, track and manage the query process, and to identify/report evolving trends in the data.
• Perform investigative site qualification, study initiation, interim monitoring, and close-out visits; co-monitor and train contract CRAs for these activities.
• Participate in project team meetings and conference calls to review progress of ongoing clinical trials.
• Assist clinical and regulatory operations staff with additional projects and tasks as determined by department and organizational needs.
Requirements and Experience:
• BS degree in a health related science or equivalent (e.g., nursing).
• 1-3 years’ experience as a CRA in the biotechnology or pharmaceutical industry.
• Willing to travel 50% of the time.
• Working knowledge of medical terminology; prior experience in oncology preferred.
• Mature, hard-working, team player that thrives in a fast-paced working environment.
• Ability to prioritize and multitask to ensure tasks that are completed on time.
• Possesses strong interpersonal and written communication skills.
• Excellent organizational and planning skills.
• Detail oriented and produces high quality work.
• Highly competent in Microsoft Office Suite including MS Word, Excel, PowerPoint with previous experience in SharePoint preferred.
• Performs job skills with minimal guidance.
• Completed (or is in the process of completing) a CRA certification Course.

If interested, contact:

Natalie Duner

Real Life Sciences
Desk Hub, 2159 India Street, Suite 200, San Diego, CA, 92101, United States
T: +1 619 881 0004