The Clinical Research Associate will design, plan, coordinate, and conduct all activities involved in initiating, monitoring, and completing clinical research studies for in vitro diagnostics.
Responsibilities include but are not limited to:
? Ensuring studies are conducted and documented in accordance with the study protocol, standard operating procedures, good clinical practices and other applicable regulatory requirements;
? Validating product performance claims;
? Supplying data for critical Regulatory submissions;
? Defining the functional and clinical utility of investigational products, and
? Obtaining opinions and input regarding investigational products from laboratories or customers, who may be considered key opinion leaders. The CRA is responsible for adhering to the policies of the quality system and achieving quality objectives through daily actions.
? Performing or coordinating aspects of 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 cross functional staff to support post launch activities. ? Reviewing cases with investigators to resolve discrepancies. Ensuring that studies adhere to FDA regulations, Good Clinical Practices, IVD directives, and Roche policies and procedures
EXPERIENCE, SKILLS, KNOWLEDGE REQUIREMENTS
? Excellent oral and written communication skills ? Excellent planning, organizing, and interpersonal skills ? Ability to work independently, make sound decisions, and to analyze and solve problems ? Demonstrated experience in computer skills to include Microsoft Office, and basic templates ? Medical laboratory experience preferred ? Up to 2 years of experience in CRA IVD role preferred but not required
? Minimum - Bachelor's degree in science or relevant field. ? Medical technology degree preferred, but not required if R&D background is adequate
DOCS is an equal opportunity employer - Minorities/Females/Disabled/Veterans and committed to providing a workplace free of any discrimination or harassment.Apply for this job