Quality Assurance Coordinator (Clinical Research)

Benefits

Qualifications

• •Must be able to effectively communicate verbally and in writing in English and Spanish
• •Minimum 1-2 years relevant experience in the clinical research industry
• •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
• •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
• •3 more items(s)

Responsibilities

• •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
• •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
• •Essential physical requirements include sitting, typing, standing, walking
• •Lightly active position, occasional lifting of up to 20 pounds
• •Reporting to work, as scheduled, is essential
• •10 more items(s)