Specialist, Research Quality Assurance - FT - Days - MHS

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. This role provides quality oversight, conducts audits and monitoring activities, supports inspection readiness, and delivers training to research personnel. The Specialist collaborates with investigators, research teams, regulatory staff, and the IRB office to promote high-quality, compliant, and ethically sound research practices across the organization.

Responsibilities

Schedules, coordinates and conducts project specific audits related to research non-compliance, high risk, high enrollment, or randomly selected investigator protocols, including monitoring for investigator initiated trials and preparation for external audits; Performs source data verification of research related documentation, issuing queries as needed, to ensure adherence to SOPs and regulatory requirements; Generates monitoring reports and communicates monitoring results to Principal Investigators, research teams, and departmental leadership; Manages post-monitoring activities and follows up on corrective and preventive actions; Escalates unacceptable findings to institutional leadership; Assists with the filing of Protocol Deviations and Serious Adverse Event reporting; Develops, updates, and maintains educational materials for research staff; Collaborates with IT teams to convert educational content into digital formats for e-learning platforms; Delivers in-person and virtual training sessions for research personnel; Ensures training content aligns with research standards, regulatory requirements, and institutional policies; Reviews Informed Consent and Assent Forms (ICFs) for completeness, accuracy, and compliance, and ensures timely correction of errors or deviations; Provides ongoing QA/QC support to research teams; Assists in identifying process gaps and recommends improvements; Supports risk assessments, root cause analyses, and continuous quality improvement initiatives; Promotes a culture of compliance, ethical conduct, and research integrity

Requirements

Bachelors degree (required); minimum of three (3) years of clinical research experience with monitoring, auditing, or QA/QC responsibilities; thorough knowledge of regulatory requirements for clinical research, including ICH GCP, FDA CFR, HIPAA, IRB processes, and institutional SOPs; knowledge of basic human anatomy, physiology, and medical terminology; bachelor's degree in science, healthcare, or a related medical field

Nice to have

Oncology and/or Hematology research experience; RN degree; knowledge of Complion (E-Regulatory system), Epic (EMR) and REDCap Database; familiarity with NCI CTSU systems, cooperative group research processes, and Clinical Trials in Oncology requirements; SOCRA (CCRP) or ACRP certification