Clinical Research Associate I

3 weeks ago

Blue Bell, United States ICON Clinical Research Full time

ICON is looking for a CRA or Histologist for a CRA I position with one of our FSP clients

**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, and

- 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:**

2 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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