RESEARCH COMPLIANCE ANALYST STUDY CONDUCT

All the benefits and perks you need for you and your family :

• Benefits from Day One
• Paid Days Off from Day One
• Student Loan Repayment Program
• Career Development

Our promise to you :

Joining AdventHealth is about being part of something bigger. Its about belonging to a community that believes in the wholeness of each person, and serves to uplift others in body, mind and spirit.

AdventHealth is a place where you can thrive professionally, and grow spiritually, by Extending the Healing Ministry of Christ.

Where you will be valued for who you are and the unique experiences you bring to our purpose-minded team. All while understanding that together we are even better.

Schedule : Full Time / Days (M-F) (8AM-5PM)

Location : 800 N. Magnolia Avenue, Suite 500, Orlando, FL 32803 (Hybrid)

The community youll be caring for :

• Located on a lush tropical campus, our flagship hospital, 1,368-bed AdventHealth Orlando
• Serves as the major tertiary facility for much of the Southeast, the Caribbean and South America
• AdventHealth Orlando houses one of the largest Emergency Departments and largest cardiac catheterization labs in the country
• We are already one of the busiest hospitals in the nation, providing service excellence to more than 32,000 inpatients and 125,000 outpatients each year

The role youll contribute :

AdventHealth Research Institute (AHRI) provides corporate level research oversight across all markets to ensure that research is performed in a consistent manner that is in full alignment with all applicable federal, state, and local rules and regulations.

The Research Compliance Analyst assists with implementation of the Research Compliance Program of the AdventHealth Research Institute (AHRI) by conducting compliance research, reviewing and synthesizing regulations and industry publications, assisting with the development of training materials and other department guidance documents.

This role gives input in the risk assessment of the Research Compliance Program and assists with research compliance related inquiries and investigations.

The Research Compliance Analyst reports to the Research Compliance Manager and will operate independently conducting assigned regular, ad hoc, and for-cause audits to monitor compliance with applicable federal and state laws, regulations, guidance, and international standards, as well as AdventHealth Research Institute (AHRI) Policies & Procedures related to responsible study conduct and the safety and protection of human subjects participating in research.

The Research Compliance Analyst will provide a report of findings, assist in Root Cause Analysis (RCA), Corrective and Preventative Action (CAPA) plan development, and follow up to ensure the study team resolves all findings and completes the CAPA adequately.

Actively participates in outstanding customer service and accepts responsibility in maintaining relationships that are equally respectful to all.

The value youll bring to the team :

• Works collaboratively with Research Compliance manager to identify, prioritize, schedule and coordinate audits to be conducted.
• Independently conducts onsite or remote internal audits of AHresearch selected programs / studies reviewing regulatory documents, research records, source data, Electronic Medical Records, and other systems used by research to assess compliance with federal, state, and international standards for GCP, applicable federal and / or state regulations, and applicable AH or external Policies and Procedures related to the conduct of research, Such as external IRBs or collaborative networks.

Research Compliance Analyst will document any noncompliance findings he / she identifies and determines during the review.

Conducting onsite audits will require travel to various AH campuses such as CFD-South, CFD- East, MSD other external out of state markets.

Documents findings objectively via an audit report and identifies required actions to bring the project into compliance in a thorough and concise manner.

Additional recommendations and / or subsequent requirements demonstrating best practices related to deficiencies identified will also be communicated in the audit report.

Upon completion of the report, ensure it is reviewed by the Research Compliance Manager, and ensure it is delivered in the appropriate manner to the responsible team members.

One-on-one and informal training may be provided while delivering and going over audit reports with PIs, and or study team members in-person or remote.

• Guides research departments, research investigators, and study teams in conducting RCAs and development of CAPAs resulting from Audit review results, activities or required by the IRB.
• Conducts follow-up of action required items identified in audit reviews, ensuring the Principal Investigator (PI), and / or research team completes the required actions within the identified timeframe as outlined in the audit report until resolution of all required actions is achieved.

Qualifications

EDUCATION AND EXPERIENCE REQUIRED :

Bachelors degree (BA / BS) in life sciences subject, including Medical Research, Nursing or related healthcare field AND Five (5) years or more of work experience in clinical research (clinical trials);

OR Associate degree in healthcare (administration or research related field); OR Documented equivalent work experience in healthcare, clinical research, or related field, AND 7 years or more of work experience in clinical research (clinical trials)

LICENSURE, CERTIFICATION, OR REGISTRATION REQUIRED :

Research certification through any professional research organization such as The Society of Clinical Research Associates (SOCRA), Association of Clinical Research Professionals (ACRP), or Society of Research Administrators International (SRA)

LICENSURE, CERTIFICATION, OR REGISTRATION PREFERRED :

• Current active State of Florida Registered Nurse or other professional licensure consistent with health-related healthcare degree as applicable
• Certification in Healthcare Research Compliance (CHRC) through the Compliance Certification Board (CCB) via the Health Care Compliance Association (HCCA).

This facility is an equal opportunity employer and complies with federal, state and local anti-discrimination laws, regulations and ordinances.

The salary range reflects the anticipated base pay range for this position. Individual compensation is determined based on skills, experience and other relevant factors within this pay range.

The minimums and maximums for each position may vary based on geographical location.

Category : Research

Organization : AdventHealth Central Florida

Schedule : Full-time

Shift : 1 - Day

Req ID : 24023209

We are an equal opportunity employer and do not tolerate discrimination based on race, color, creed, religion, national origin, sex, marital status, age or disability / handicap with respect to recruitment, selection, placement, promotion, wages, benefits and other terms and conditions of employment.