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JOB SUMMARY

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:
• CCRA: Clinical Research Associate
• CCRC: Clinical Research Coordinator
• CCRP: Certified Clinical Research Professional
• ACRP-CP: ACRP-Certified Professional".