Specialist, Research Quality Assurance - FT - Days - MHS

CO010 Memorial Healthcare System; United States; On-site; USD 90,000 - 130,000; Full time

Job summary

Memorial Healthcare System is seeking a Research Quality and Assurance Specialist to ensure clinical research activities meet federal regulations, institutional policies, and ethical standards. You will provide quality oversight, conduct audits, support inspection readiness, and deliver training to research personnel.

You will collaborate with investigators, regulatory staff, and the IRB office to promote compliant research practices across the organization and drive continuous quality

Qualifications

• Three years of clinical research QA/audit experience required.
• Oncology or hematology research experience strongly preferred.
• Knowledge of regulatory requirements (ICH GCP, FDA CFR, HIPAA) required.

Responsibilities

• Schedules, coordinates and conducts project audits related to research non compliance and regulatory requirements.
• Performs source data verification of research documentation and issues queries as needed.
• Generates monitoring reports and communicates results to Principal Investigators and research teams.
• Manages post monitoring activities and CAPA follow‑up with minimal oversight.
• Develops, updates and maintains educational materials for research staff and delivers training.
• Reviews Informed Consent and Assent Forms for completeness and compliance.

Skills

Quality assurance

Auditing

Regulatory compliance

Training delivery

Project management

Documentation

Education

Bachelor's degree

Tools

Complion

Epic

REDCap

NCI CTSU systems

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. 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.

Be where care matters. At Memorial Healthcare System, we are dedicated to improving the health, well-being, and quality of life of the people entrusted to our care. This unwavering commitment to our service vision makes the difference and is the foundation of The Memorial Experience. Deeper Caring. Smarter Healthcare. Talk to our patients and their families about “Deeper Caring,” and they'll tell you stories about miracle babies, lives saved through sheer determination, and the comforting kindness of others. About people who advocated for the family’s best interests and cared for them in body, mind, and spirit. For our employees, “Smarter Healthcare” means constantly improving how we deliver care. It could be a new technology, a streamlined process, or a cutting-edge program leveraging our system strengths. But, no matter how you look at it, our service vision is integral to our culture today and what we strive to be tomorrow. We invite you to share in the Memorial Experience – where touching lives, lifting spirits, and healing the human body is our profession’s greatest privilege and reward. Be where you are valued.

Memorial Healthcare System provides preference as part of our commitment to honoring the service and sacrifice of veterans in alignment with state regulations. Veteran’s Preference allows for the first choice in interviewing, hiring, retention, and promotion after deployment when all other applicant qualifications are equal. However, Veteran's Preference does not guarantee a job. Who is eligible for Veteran’s Preference? We are proud to offer preference to internal and external applicants who identify within these categories: veterans, disabled veterans, spouse of a disabled veteran, unremarried veteran widow/widower, certain family members, active reservists and members of the National Guard. What should I do if I am eligible for Veteran’s Preference? You must claim your Veteran’s Preference status on your application. If selected for a job, you must provide documentation regarding your status. How does Memorial verify that someone is eligible for Veteran’s Preference? We require specific documentation as determined by the basis for which someone claims preference. For example, the documentation for a disabled veteran is different from the documentation required for the spouse of a veteran killed in the line of duty. How often can an eligible person claim Veteran's Preference at Memorial? There is no limit to how often internal or external applicants can use preference when a job is posted externally on our career website or elsewhere. What if there are two equally qualified, preference-eligible job applicants? In this case, the selection is based on the eligibility category in accordance with Florida law. First preference is given to: An honorably discharged veteran who has served on active duty and has a service-connected, compensable disability. A spouse of a person who has a total, permanent, service-connected disability and cannot qualify for employment. A spouse of a person missing in action, captured or forcibly detained or interned by a foreign government or power. What do I do if I am denied Veteran's Preference? If you feel you have been unfairly denied Veteran’s Preference by Memorial Healthcare System, please contact [e-mail]. You may also file a complaint with the Florida Department of Veterans’ Affairs (FDVA).

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