Home Job Postings Clinical Research Project Associate/Business Development Assistant This topic has replies, 1 voice, and was last updated 8 years ago by HR. Now Editing “Clinical Research Project Associate/Business Development Assistant” Name * Password * Email Topic Title (Maximum Length 80) Company * Location Expires at <strong>Clinical Research Project Associate</strong> 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 <strong> Business Development Assistant</strong> Essential Functions • Assist senior team members with in the planning, preparation, and all BD activities • Provide timely feedback on overall market situation, competition and new business opportunities • Plan and execute marketing activities such as advertising, exhibition, and sales meeting & training • Assist in developing and managing current customer Data Base. • Assist data cleaning and coding activities. • Participate in conference calls and/or meetings with client meetings as necessary. • Assist in company's networking, including trade shows and other industry functions as necessary. Required Qualifications: • Degree in health- or biological science-related field preferred • 0-2 years of Business Development experiences required. • Working Knowledge of GCP, GMP, clinical research, ICH guidelines and related regulatory requirement. • Proficiency with Microsoft Excel, Microsoft Word, Microsoft PowerPoint, Microsoft Outlook, and Adobe Acrobat. • Follow-up skills, ethical and honest personality • Fluency in the Korean language preferred Email to : danjung@kcrnresearch.com I agree to the terms of service Update List
