Ref #: 25252

Employment type: Permanent - Full-Time

Location: US- Indianapolis IN

Description

DOCS is currently seeking clinical laboratory professionals for Clinical Research Associate roles supporting In Vitro Diagnostic studies. The CRA will lead in the designing, planning, coordinating, and conducting all activities involved in initiating, monitoring, and completing clinical research studies for in vitro diagnostics.

The CRA's duties will include but are not limited to:
• Performing or coordinating aspects of external clinical studies including site selection, study initiation, site monitoring, and study closeout.
• Maintaining communication with study investigators to ensure studies are completed in a timely fashion and ensuring that study objectives are met.
• Interfacing with other staff to support post launch activities.
• Reviewing cases with investigators to resolve discrepancies.
• Understanding and implementing federal regulations, helping to develop standard operating procedures in order to ensure that studies adhere to FDA regulations, Good Clinical Practices, IVD directives, and company policies and procedures.

Qualifications
• Minimum - Bachelor's degree in science or relevant field.
• Medical technology degree preferred, but not required if R&D background is adequate
• Medical laboratory experience preferred

DOCS is the FSP division of ICON Clinical Research. We provide global strategic resourcing and FSP services to the biopharmaceutical and medical device industries. Founded in 1997, DOCS has grown to become the premier resourcing provider for the clinical development industry.

DOCS is an equal opportunity employer - Minorities/Females/Disabled/Veterans and committed to providing a workplace free of any discrimination or harassment.