Quality Assurance Coordinator (Clinical Research)

About Us

• Each of CenExel’s research sites specialize in Phase I to Phase IV clinical trials.
• Our Centers of Excellence comprise some of the most well respected and long-standing research facilities in the country.
• Specialty areas of research across our sites include Psychiatry, Acute Post Op Pain, Asian Bridging, Dermatology, GI, and Neurology.
• Each of our Centers of Excellence has tremendous experience and expertise in complex early phase trials, and all our sites have in-patient capability.
• We focus on quality people, teamwork, and highly experienced clinical research managers with a history of success.

Along with an exceptional work environment that promotes teamwork, positive leadership, and optimal work-life balance, CenExel Clinical Research also provides highly competitive compensation and a generous benefits package to full time employees after 30 days of employment including Health Insurance, Dental, Vision, LTD, STD, Life Ins, and 401k.

Job Summary

Ensure that highest standards of data quality and study participant safety are maintained, as well as adherence to study protocols, CenExel SOPs, Site Working Practices (WPs), ICH GCP, Code of Federal Regulations, and IRB Guidelines.

Essential Responsibilities and Duties

• Assists the QA Manager in the development, implementation and follow-up of quality assurance programs including necessary or appropriate policies and guidelines.
• Reviews follow-up monitoring visit reports, protocol deviation logs, and quality findings trackers for trend analysis.
• Performs ongoing review of a percentage sampling of study inclusion/exclusion, study procedure records, and laboratory reports to ensure that they are conducted according to the protocol, applicable SOPs, ICH/GCP guidelines and federal regulations.
• Performs quality review of initially created source documentation, including amendments, to ensure all protocol required procedures are present.
• Prepares for internal and external audits and FDA inspections.
• Attends staff meetings.
• Attends site initiation visits as needed.
• Supports and ensures strictest adherence to best practices, FDA Code of Federal Regulations, ICH (International Conference on Harmonization), GCP (Good Clinical Practices), CenExel standard operating procedures, site working Practices, protocol, and company guidelines and policies.