Quality Assurance Coordinator II

CenExel•Evesham Township, NJ

9d•$30 - $39•Onsite

About The Position

Ensure that high standards of data s and subject safety are maintained, as well as well as study protocols, SOPs/SWPs, ICH/GCP and IRB guidelines, federal regulations are consistently being followed.

Requirements

Must be able to effectively communicate verbally and in writing.
Must have proper experience and demonstrate mastery of Quality Assurance Coordinator I position.
Experience: Minimum 1-2 years relevant experience
Knowledge/Skills/Abilities: 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

Responsibilities

Assist the QA Manager in the development, implementation and follow-up of quality assurance programs including necessary or appropriate policies and guidelines
Review follow-up monitoring visit reports, protocol deviation logs, and quality findings trackers for trend analysis
Perform 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
Perform quality review of initially created source documentation, including amendments, to ensure all protocol required procedures are present
Provide training and education on SOPs, GCP, and federal regulations as appropriate
Prepare for internal and external audits
Attend staff meetings
Attend site initiation visits as needed
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.