ICON is looking for a Histologist looking to get into a CRA I position!
Below, you will find a complete breakdown of everything required of potential candidates, as well as how to apply Good luck.
Responsibilities :
The Clinical Research Associate (CRA) will lead in designing, planning, coordinating, and conducting all activities involved in initiating, monitoring, and completing clinical research studies for in vitro diagnostics.
Responsibilities include :
- 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;
- Obtaining opinions and input regarding investigational products from laboratories or customers, who may be considered key opinion leaders;
- 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 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, policies and procedures.
Qualifications :
- 5 years of experience as a Clinical Research Associate, with specific in vitro diagnostics study experience preferred;
- CRA certification by recognized professional organization is a plus, but not mandatory;
- Excellent oral and written communication skills;
- Excellent planning, organizing, interpersonal and leadership skills;
- Ability to work independently to make sound decisions and to analyze and solve problems;
- Demonstrated experience in computer skills to include Microsoft Word, Excel, and basic templates;
- Statistical knowledge;
- Supervision experience or experience in a leadership role preferred.
Minimum - Bachelor's degree in relevant field. Medical technology degree preferred, but not required if R&D background is adequate.
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