The Research Quality Assurance Coordinator 1 performs quality assurance functions for BSWRI clinical research projects according to Federal Guidelines and Good Clinical Practices (GCP). Provide QA oversight for all aspects of carrying out a clinical trial which can be included but not limited to informed consent, drug accountability, inclusion and exclusion criteria, and good documentation practices.
ESSENTIAL FUNCTIONS OF THE ROLE
Establishes written procedures and develops plans for quality assurance reviews for clinical research projects as assigned across BSWRI locations. When required, creates, writes or edits SOP?s, procedures, and forms.
Develops appropriate quality assurance plans based on the complexity of the protocol, number of subjects, rate of enrollment, SOP and staff experience with guidance from operations leadership
Conducts scheduled quality reviews at various BSWRI locations.
Reviews that investigator and/or designee and all involved research staff follow the approved protocol and all applicable federal and local guidelines and GCP guidelines
Reviews that all research staff have the appropriate qualifications and resources to conduct the clinical investigation
Reviews billing compliance adherence and clinical trial management system data
Maintains records of findings, action plans (as applicable), and meetings with site research staff, leadership, and principal investigators.
Builds productive relationships with site and works to resolve issues
As needed observe the informed consent process to proactively identify opportunities for improvement to effectively meet BSWRI policies and federal regulations.
Maintain knowledge of QA requirements, systems, methods and best practices through training and self-study.
KEY SUCCESS FACTORS
Knowledge of GCP requirements, FDA Regulations, and ICH guidelines
Knowledge of preparation and submission of clinical regulatory documentation
Strong Written and Oral Communication Skills
Strong Computer Skills, including Microsoft office, Excel, and PowerPoint
Ability to manage time-sensitive projects in order to meet deadlines
Location: Dallas or Plano
Schedule: Full Time, 1 day remote
BENEFITS
Our competitive benefits package includes the following
Immediate eligibility for health and welfare benefits
401(k) savings plan with dollar-for-dollar match up to 5%
Tuition Reimbursement
PTO accrual beginning Day 1
Note: Benefits may vary based upon position type and/or level
QUALIFICATIONS
EDUCATION - Bachelor's
EXPERIENCE - 4 Years of Experience
CERTIFICATION/LICENSE/REGISTRATION
Cert Clinical Research Assoc (CCRA), Cert Clinical Research Coord (CCRC), CCRP-Cert Clnl Research Prof (CCRP-RES): "Must obtain one of the following from SOCRA or ACRP within 6 months of hire:
Baylor Scott & White Health (BSWH) is the largest not-for-profit health care system in Texas and one of the largest in the United States. With a commitment to and a track record of innovation, collaboration, integrity and compassion for the patient, BSWH stands to be one of the nation’s exemplary health care organizations. Our mission is to serve all people by providing personalized health and wellness through exemplary care, education and research as a Christian ministry of healing. Joining our team is not just accepting a job, it’s accepting a calling!
