Specialist, Research Quality Assurance - FT - days

Memorial Healthcare

14d•Onsite

About The Position

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.

Requirements

Bachelors (Required)
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.
A minimum of three (3) years of clinical research experience with monitoring, auditing, or QA/QC responsibilities required.

Nice To Haves

RN degree preferred.
Oncology and/or Hematology research experience strongly 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.

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.
Ensures training content aligns with research standards, regulatory requirements, and institutional policies.
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.
Assists in identifying process gaps and recommends improvements to enhance research operations.
Supports risk assessments, root cause analyses, and continuous quality improvement initiatives.
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.
Manages post-monitoring activities and follows up on necessary corrective and preventive actions.
Escalates unacceptable findings to institutional leadership.
Assists with the filing of Protocol Deviations and Serious Adverse Event reporting.