Specialist, Research Quality Assurance - FT - days

About the role

The Research Quality and Assurance Specialist supports the research program at Memorial Healthcare System by ensuring that clinical research activities comply with federal regulations, institutional policies, and ethical standards.

Responsibilities

• Develops, updates, and maintains educational materials for research staff, including presentations, guides, and training modules.
• Collaborates with IT teams to support the conversion of educational content into digital formats for e-learning platforms.
• Delivers in-person and virtual training sessions for investigators, coordinators, regulatory staff, pharmacists, APPs, residents, fellows, and other research personnel.
• Reviews Informed Consent and Assent Forms (ICFs) for completeness, accuracy, and compliance with regulatory and institutional requirements.
• Identifies errors or deviations and ensures timely correction and documentation.
• Provides ongoing QA/QC support to research teams to ensure high quality documentation and data integrity.
• Affords assistance in identifying process gaps and recommending improvements to enhance research operations.
• Promotes a culture of compliance, ethical conduct, and research integrity across the institution.
• Schedules, coordinates, and conducts project-specific audits related to allegations of research non-compliance, high-risk, high-enrollment, or randomly selected investigator protocols, including providing monitoring for investigator-initiated trials and preparation for external audits.
• Performs source data verification of research-related documentation (e.g., investigator qualifications, staff training, Electronic Medical Record, etc.), issuing queries as needed, to ensure proper adherence to SOPs and applicable regulatory requirements.
• Generates monitoring reports and communicates monitoring results to Principal Investigators, research teams, and departmental leadership.
• Escalates unacceptable findings to institutional leadership.
• Assists with the filing of Protocol Deviations and Serious Adverse Event reporting.

Qualifications

• Bachelor's degree in science, healthcare, or a related medical field; RN degree preferred.
• Knowledge of Complion (E-Regulatory system), Epic (EMR) and REDCap Database preferred.
• Familiarity with NCI CTSU systems, cooperative group research processes, for Clinical Trials in Oncology requirements preferred.
• SOCRA (CCRP) or (ACRP) certification preferred.
• A minimum of three (3) years of clinical research experience with monitoring, auditing, or QA/QC responsibilities required.
• Oncology and/or Hematology research experience strongly preferred.

Skills

• Professional judgment
• Decision making
• Deep expertise in clinical research regulations and quality systems
• Analysis of nuanced documentation
• Data verification
• Expert guidance
• Collaboration
• Development of training and educational materials
• Compliance with regulatory and institutional requirements
• Identification of process gaps and recommendations for improvements
• Continuous quality improvement initiatives
• Compliance with institutional SOPs
• Knowledge of regulatory requirements for clinical research, including ICH GCP, FDA CFR, HIPAA, IRB processes
• Basic human anatomy, physiology, and medical terminology
• Effective communication
• Customer service
• Accountability
• Accuracy
• Responding to change
• Standards of behavior

Benefits

Memorial Healthcare System offers competitive benefits packages to support the health and well-being of our employees and their families. These benefits may include:

• Health insurance
• Vision and dental coverage
• Retirement savings plans
• Flexible spending accounts
• Employee assistance programs
• Parental leave
• Maternity and paternity leave
• Family and medical leave
• Time off for personal and family needs
• Discounted services and products
• Professional development opportunities
• Community involvement programs

Pay

Compensation for this role is commensurate with experience and qualifications. Please contact your Memorial Healthcare System recruiter for more details.

Schedule

This role is primarily based in an office setting. The schedule is typically full-time, but flexible arrangements may be available upon request.