Job Description
The IVD Clinical Research Associate will design, plan, coordinate, and conduct all activities involved in initiating, monitoring, and completing clinical research studies for in vitro diagnostics.
A variety of soft skills and experience may be required for the following role Please ensure you check the overview below carefully.
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.
JOB FUNCTIONS/RESPONSIBILITIES
* 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 client 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 stipulation. General clinical trials experience/deep understanding.
Up to 2 years of experience in CRA IVD role preferred but not required.
Must be able to travel within UK and EU region on occasion.
EDUCATION REQUIREMENTS
* Minimum - Bachelor's degree in science or relevant field.
Medical technology degree preferred, but not required if R&D background is adequate