Ref #: 26524

Employment type: Permanent - Full-Time

Location: US- East Coast - Remote

Posted: 29-Jan-2021

Description

The Clinical Research Associate II will be responsible for designing, planning, coordinating, and conducting all activities involved in initiating, monitoring, and completing clinical research studies. 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 maintaining and continuously improving 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 other cross functional staff to support post launch activities.
• Reviewing cases with investigators to resolve discrepancies.

Requirements:
• Minimum - Bachelor's degree in science or relevant field.
• At least 4 years of Clinical Research experience with 3 years of experience as a
Clinical Research Associate.

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.

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