• GERMANTOWN
• /
• MD

Clinical Research Project Associate
KCRN Research, LLC is a contract research organization (CRO) that is committed to providing clinical and regulatory services to pharmaceutical/biotech companies.
KCRN Research, an established international contract research organization serving both commercial as well as government markets, is conducting a search for a full-time Project Associate in Clinical Operations to be based at the company’s office in Germantown, MD. Visa sponsorship available.

* This position will support a variety of trials, covering a wide range of therapeutic areas.
Primary Responsibilities
• Provide input into and/or develop study related materials such as clinical study protocol, informed consent forms, study plans, and investigator site file documents
• Monitor projects on an ongoing basis, evaluate progress and quality, manage issue resolution process and take corrective action as necessary
• Ensure the quality of all documents and data to assure the project’s integrity
• Assist and work with the Project Manager to support the development and management of the project
• Review regulatory documents. Review includes assessment of completeness and compliance with regulatory requirements
• Support safety reporting and IRB submissions
• Facilitate site study drug orders, and ensure site accountability records are maintained
• Communicate and coordinate effectively with internal and external clients and colleagues
• Maintain clinical trial master files to ensure compliance with required regulatory and GCP quality standards
• Perform and/or oversee site monitoring visits for clinical trials as needed
Requirements
• Degree in health- or biological science-related field preferred
• 2 years of prior experience in the research or pharmaceutical industry
• Knowledge of ICH GCP, and HSP regulations
• Experiences in a variety of therapeutic areas a plus but not required
• Detail oriented, good oral and written communication skills required

Email to : danjung@kcrnresearch.com