Specialist, Research Quality Assurance - FT - Days - MHS

Memorial Healthcare; United States; On-site; USD 85,000 - 125,000; Full time

Job summary

Memorial Healthcare System seeks a Research Quality and Assurance Specialist to ensure clinical research complies with federal regulations, policies and ethical standards. You will provide quality oversight, conduct audits, and support inspection readiness across the organization.

You will develop training materials, review ICFs for compliance, manage CAPA follow-up, and partner with investigators, regulatory staff, IRB, and IT to improve data integrity and research quality.

Qualifications

• Bachelor's degree in science, healthcare, or related field.
• Minimum 3 years in clinical research QA/auditing.
• Familiarity with regulatory requirements (ICH GCP, FDA CFR, HIPAA) and IRB processes.

Responsibilities

• Plan and conduct audits of research protocols and non-compliance investigations.
• Perform source data verification and queries to ensure data integrity.
• Generate monitoring reports and communicate results to investigators and leadership.
• Manage CAPA follow-up and corrective actions.
• Develop and deliver training materials for research staff and investigators.
• Review informed consent forms for completeness and regulatory compliance.

Skills

Regulatory compliance

Clinical audits

Quality assurance

CAPA follow-up

Training delivery

Education

Bachelor's degree in science/healthcare

Tools

Complion

Epic

REDCap

Job description

At Memorial, we are dedicated to improving the health, well-being and, most of all, quality of life for the people entrusted to our care. An unwavering commitment to our service vision is what makes the difference. It is the foundation of The Memorial Experience.

Summary:

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 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.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.

Competencies:

ACCOUNTABILITY, ACCURACY, CUSTOMER SERVICE, DEVELOPS RELATIONSHIPS, EFFECTIVE COMMUNICATION, RESEARCH - PROJECT MANAGEMENT, RESEARCH - REPORTING, RESPONDING TO CHANGE, STANDARDS OF BEHAVIOR

Education and Certification Requirements:

Bachelors (Required)

Additional Job Information:

Complexity of Work: This role requires professional judgment, decision making, and deep expertise in clinical research regulations and quality systems. Work involves analyzing nuanced documentation, performing detailed data verification, and managing CAPA follow up with minimal oversight. The position influences institutional research practices through expert guidance, cross functional collaboration, and development of training and educational materials. Decisions made in this role directly impact regulatory readiness, research integrity, and organizational risk. 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. Required Work Experience: 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. Other Information: Additional Education Info: 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.

Working Conditions and Physical Requirements:

• Bending and Stooping = 0%
• Climbing = 0%
• Keyboard Entry = 80%
• Kneeling = 0%
• Lifting/Carrying Patients 35 Pounds or Greater = 0%
• Lifting or Carrying 0 - 25 lbs Non-Patient = 0%
• Lifting or Carrying 2501 lbs - 75 lbs Non-Patient = 0%
• Lifting or Carrying > 75 lbs Non-Patient = 0%
• Pushing or Pulling 0 - 25 lbs Non-Patient = 0%
• Pushing or Pulling 26 - 75 lbs Non-Patient = 0%
• Pushing or Pulling > 75 lbs Non-Patient = 0%
• Reaching = 0%
• Repetitive Movement Foot/Leg = 0%
• Repetitive Movement Hand/Arm = 80%
• Running = 0%
• Sitting = 80%
• Squatting = 0%
• Standing = 80%
• Walking = 80%
• Audible Speech = 80%
• Hearing Acuity = 80%
• Smelling Acuity = 0%
• Taste Discrimination = 0%
• Depth Perception = 80%
• Distinguish Color = 80%
• Seeing - Far = 80%
• Seeing - Near = 80%
• Bio hazardous Waste = 0%
• Biological Hazards - Respiratory = 0%
• Biological Hazards - Skin or Ingestion = 0%
• Blood and/or Bodily Fluids = 0%
• Communicable Diseases and/or Pathogens = 0%
• Asbestos = 0%
• Cytotoxic Chemicals = 0%
• Dust = 0%
• Gas/Vapors/Fumes = 0%
• Hazardous Chemicals = 0%
• Hazardous Medication = 0%
• Latex = 0%
• Computer Monitor = 80%
• Domestic Animals = 0%
• Extreme Heat/Cold = 0%
• Fire Risk = 0%
• Hazardous Noise = 0%
• Heating Devices = 0%
• Hypoxia = 0%
• Laser/High Intensity Lights = 0%
• Magnetic Fields = 0%
• Moving Mechanical Parts = 0%
• Needles/Sharp Objects = 0%
• Potential Electric Shock = 0%
• Potential for Physical Assault = 0%
• Radiation = 0%
• Sudden Decompression During Flights = 0%
• Unprotected Heights = 0%
• Wet or Slippery Surfaces = 0%

Shift:

Primarily for office workers - not eligible for shift differential

Disclaimer:

This job description is not intended, nor should it be construed to be an exhaustive list of all responsibilities, skills, efforts or working conditions associated with the job. It is intended to indicate the general nature and level of work performed by employees within this classification.

Wages shown on independent job boards reflect market averages, not specific to any employer. We encourage candidates to talk to their Memorial Healthcare System recruiter to discuss actual pay rates, during the hiring process.

Memorial Healthcare System is proud to be an equal opportunity employer committed to workplace diversity.

Memorial Healthcare System recruits, hires and promotes qualified candidates for employment opportunities without regard to race, color, age, religion, gender, sexual orientation, national origin, veteran status, disability, genetic information, or any factor prohibited by law.

We are proud to offer Veteran’s Preference to former military, reservists and military spouses (including widows and widowers). You must indicate your status on your application to take advantage of this program.

Employment is subject to post offer, pre-placement assessment, including drug testing.

If you need reasonable accommodation during the application process, please call 954-276-8340 (M-F, 8am-5pm) or email [e-mail]