Quality Assurance Coordinator II (Clinical Research)

CenExel•Decatur, GA

24d•$24 - $35•Onsite

About The Position

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. Compensation : $23.65/h - $35.35/h depending on education, experience, and skillset. 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.

Requirements

Must be able to effectively communicate verbally and in writing.
Must have proper experience and demonstrate mastery of Quality Assurance Coordinator I position.
Minimum 2 years quality assurance experience.
Must be self-directed and able to work with minimal supervision
Must have in depth knowledge of FDA regulations. GCP, and ICH guidelines
Able to take a flexible approach to shifting priorities
Able to manage multiple projects and responsibilities
Motivated to work consistently in a fast paced and rapidly changing environment
Must be detail oriented and have exceptional computer, organizational, and communication skills – both written and oral.
Must reflect the professional image of the company, upholding the company vision in actions, demeanor, and appearance.
Must be able to clearly communicate through written and verbal means with sponsors and staff.

Responsibilities

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.
Provides training and education on SOPs, GCP, and federal regulations as appropriate.
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.
Assumes other duties and responsibilities as assigned.