QA Coordinator Sr

CenExel

4d•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 have proper experience and demonstrate mastery of Quality Assurance Coordinator II position.
High school graduate or equivalent; Bachelors degree or equivalent, preferred.
Minimum 3 years quality assurance 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.
Provide guidance to team members, especially junior staff, to foster skill development and career advancement.
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.
Must be able to effectively communicate verbally and in writing.

Responsibilities

Assists the QA Manager in the development, implementation and follow-up of quality assurance programs including necessary or appropriate policies and guidelines.
Assists the QA Manager in conducting periodic audits of clinical research data, facilities, and processes.
Assists QA Manager in the development of Corrective and Preventative Action (CAPA) Plans, including evaluation of effectiveness.
Assists QA Manager in overseeing Risk Management Plans and collaborates with senior leadership and research teams to identify and mitigate risks for all clinical studies.
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.
Reviews regulatory documents for completion and accuracy as assigned.
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. 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.