Research Quality Spec, HRPP (*This position is onsite, no remote*)

Sarasota Memorial Health Care System; Sarasota (FL); Remote; USD 60,000 - 90,000; Full time

Job summary

An established industry player in healthcare is seeking a dedicated professional to enhance their Human Research Protection Program. This role offers an exciting opportunity to conduct quality assurance reviews and audits, ensuring compliance with essential regulations while supporting clinical research initiatives. You'll collaborate closely with investigators and study staff, fostering a culture of education and process improvement. If you're passionate about advancing healthcare research and committed to quality, this position promises career growth and a chance to make a significant impact in the field.

Qualifications

• Bachelor's degree in a relevant field and 3 years in IRB Human Subject Protection.
• Certification as CIP, CCRC, CCRP, CQA, or CQAP required within 2 years.

Responsibilities

• Conduct quality assurance reviews and audits of research studies.
• Ensure compliance with federal and state laws and employer requirements.
• Collaborate with clinical research monitors or auditors.

Skills

Quality Assurance

Compliance

Critical Thinking

Communication Skills

Organizational Skills

Education

Bachelor’s degree in nursing, science, or health-related management

Tools

Microsoft Office

IRBNet.org

Job description

Employer Industry: Research and Healthcare

Why consider this job opportunity:
- Opportunity for career advancement and growth within the organization
- Engaging work that supports the Human Research Protection Program
- Comprehensive involvement in quality assurance reviews and audits of research studies
- Chance to collaborate with Investigators and study staff for compliance improvements
- Strong focus on education and process development in research practice

What to Expect (Job Responsibilities):
- Conduct ongoing quality assurance reviews and audits of research studies
- Assess site readiness and develop site-specific education and processes
- Ensure compliance with federal, state laws, and employer requirements
- Identify opportunities to improve processes, education, and compliance related to research practice
- Collaborate with clinical research monitors or auditors on various research studies

What is Required (Qualifications):
- Bachelor’s degree in an appropriate field (nursing, science, or health-related management)
- Minimum of three (3) years of experience in an IRB Human Subject Protection role or clinical research
- Certification as CIP, CCRC, CCRP, CQA, or CQAP, or must be obtained within two (2) years of eligibility
- Current state of Florida Registered Nurse (RN) licensure (active, eligible, or retired)
- Relevant field experience can be considered in lieu of degree requirement on a year-for-year basis

How to Stand Out (Preferred Qualifications):
- Past auditing experience or similar quality assurance activities related to clinical trials
- Knowledge of Federal regulations related to human subject protection, e.g., DHHS, FDA
- Strong verbal, written, and interpersonal communication skills
- Excellent organizational, critical thinking, and problem-solving skills
- Proficiency in Microsoft Office, including Word, Excel, PowerPoint, and familiarity with IRBNet.org

#Research #Healthcare #QualityAssurance #ClinicalTrials #CareerOpportunity

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