Clinical Research QA & Compliance Specialist

Memorial Healthcare System; Florida; On-site; USD 85,000 - 120,000; Full time

Job summary

Memorial Healthcare System seeks a Research Quality and Assurance Specialist to oversee compliance with federal regulations, institutional policies, and ethical standards. You will conduct audits, perform source data verification, generate monitoring reports, and manage CAPA activities across investigator-initiated trials and external audits.

You will develop and deliver educational materials and training for investigators, coordinators, regulatory staff, pharmacists, APPs, residents, and

Qualifications

• Bachelor’s degree in science, healthcare, or related medical field.
• RN degree preferred.
• Thorough knowledge of regulatory requirements for clinical research, ICH GCP, FDA CFR, HIPAA, IRB processes.
• Familiarity with Complion, Epic, and REDCap.
• SOCRA or ACRP certification preferred.

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 monitoring for investigator initiated trials and externals audits.
• Performs source data verification of research-related documentation and issues queries to ensure adherence to SOPs and regulatory requirements.
• Generates monitoring reports and communicates results to Principal Investigators, research teams, and leadership; manages post-monitoring actions and CAPA follow-up.
• Develops, updates, and maintains educational materials for research staff; delivers in-person and virtual training for investigators, coordinators, regulatory staff, pharmacists, APPs, residents, and fellows.
• Reviews Informed Consent and Assent Forms for completeness and compliance, identifying errors and ensuring timely corrections.
• Provides ongoing QA/QC support to identify process gaps and supports risk assessments and continuous quality improvement.
• Promotes a culture of compliance, ethical conduct, and research integrity across the institution.

Skills

Regulatory compliance

Quality assurance

Auditing & monitoring

Training delivery

Cross-functional collaboration

Education

Bachelor's degree in science, healthcare, or related field

RN degree preferred

Tools

Complion (E-Regulatory system)

Epic (EMR)

REDCap Database

Job description

Memorial Healthcare System seeks a Research Quality and Assurance Specialist to oversee compliance with federal regulations, institutional policies, and ethical standards. You will conduct audits, perform source data verification, generate monitoring reports, and manage CAPA activities across investigator-initiated trials and external audits.

You will develop and deliver educational materials and training for investigators, coordinators, regulatory staff, pharmacists, APPs, residents, and