Clinical Research Associate, Sponsor Dedicated, IVD

IQVIA•Durham, NC

1d•$90,200 - $197,500

About The Position

The Clinical Research Associate (CRA) designs, plans, coordinates, and conducts activities to initiate, monitor, and complete clinical research studies for in vitro diagnostics (IVD). The role helps ensure studies follow protocols, standard operating procedures, good clinical practices, and applicable regulatory requirements; validates product performance claims; supplies data for regulatory submissions; defines the functional and clinical utility of investigational products; and obtains input on investigational products from laboratories or customers, including key opinion leaders. The CRA also maintains and continuously improves the quality system and supports achievement of quality objectives through daily actions. The CRA performs or coordinates site selection, study initiation, site monitoring, and study closeout; communicates with investigators to support timely study completion and achievement of objectives; and works with cross-functional staff on post-launch activities. The role includes reviewing cases with investigators to resolve discrepancies and understanding and implementing federal regulations, as well as helping develop standard operating procedures to ensure compliance with FDA regulations, Good Clinical Practices, IVD directives, and client policies and procedures.

Requirements

At least 2 years of experience as a Clinical Research Associate, with specific experience in in vitro diagnostics studies.
Excellent oral and written communication skills.
Excellent planning, organizing, interpersonal, and leadership skills.
Ability to work independently, make sound decisions, and analyze and solve problems.
Demonstrated computer skills, including Microsoft Word, Excel, and basic templates.
Minimum bachelor's degree in science or a relevant field.

Nice To Haves

CRA certification by a recognized professional organization.
Medical technology degree; not required if the candidate has an adequate R&D background.

Responsibilities

Design, plan, coordinate, and conduct activities involved in initiating, monitoring, and completing IVD clinical research studies.
Ensure studies are conducted and documented in accordance with study protocols, standard operating procedures, good clinical practices, and applicable regulatory requirements.
Validate product performance claims and supply data for regulatory submissions.
Define the functional and clinical utility of investigational products.
Obtain opinions and input regarding investigational products from laboratories or customers, including key opinion leaders.
Maintain and continuously improve the quality system and help achieve quality objectives through daily actions.
Perform or coordinate site selection, study initiation, site monitoring, and study closeout.
Communicate with study investigators to support timely completion and ensure study objectives are met.
Interface with cross-functional staff to support post-launch activities.
Review cases with investigators to resolve discrepancies.
Understand and implement federal regulations and help develop standard operating procedures to ensure studies adhere to FDA regulations, Good Clinical Practices, IVD directives, and client policies and procedures.