Quality Assurance Coordinator

CenExel•Decatur, GA

16h•$53,000 - $55,000•Onsite

About The Position

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.
High school graduate or equivalent, Bachelors degree or equivalent preferred.
Minimum 1-2 years relevant experience in the clinical research industry.
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.
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.
The above responsibilities are a general description of the level and nature of the work assigned to this classification and are not to be considered as all inclusive.