Clinical Research Quality Assurance Specialist
1 week ago
About Us: CenExel's research sites specialize in Phase I to Phase IV clinical trials. Our Centers of Excellence have a strong reputation for conducting complex early phase trials. We focus on quality people, teamwork, and experienced clinical research managers with a history of success.
Job Summary: Ensure that high standards of data quality and subject safety are maintained, as well as study protocols, SOPs/SWPs, ICH/GCP and IRB guidelines, federal regulations are consistently being followed.
Responsibilities:
* Assist the QA Manager in developing and implementing quality assurance programs
* Review follow-up monitoring visit reports, protocol deviation logs, and quality findings trackers for trend analysis
* Perform ongoing review of study inclusion/exclusion, study procedure records, and laboratory reports to ensure compliance with protocols and regulations
* Provide training and education on SOPs, GCP, and federal regulations as appropriate
* Prepare for internal and external audits
* Attend staff meetings and site initiation visits as needed
Requirements:
* Bachelor's degree or equivalent preferred
* Minimum 1-2 years relevant experience
* In-depth knowledge of FDA regulations, GCP, and ICH guidelines
* Self-directed and able to work with minimal supervision
* Excellent communication and organizational skills
CenExel Clinical Research is an Equal Opportunity Employer. All applicants will be considered for employment without regards to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or status.
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