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Overview
Our team members are the heart of what makes us better.
At Hackensack Meridian Health we help our patients live better, healthier lives — and we help one another to succeed. With a culture rooted in connection and collaboration, our employees are team members. Here, competitive benefits are just the beginning. It’s also about how we support one another and how we show up for our community.
Together, we keep getting better - advancing our mission to transform healthcare and serve as a leader of positive change.
The Research Compliance Auditor is a key contributor to HMH’s Research Compliance Audit and Monitoring Program (RCAMP) which is responsible for post-approval review and auditing of Hackensack Meridian Health Research portfolio for compliance with applicable policies, regulations, and best practices. The Research Compliance Auditor is also responsible for identifying and developing resources to support research compliance including but not limited to providing guidance and education on all areas of research compliance. This includes: FDA regulated clinical trials, human subjects research, federally and industry sponsored research. The position requires excellent attention to detail, good communication, initiative, and the ability to effectively manage competing high priority tasks. The position will report to the Research Compliance Officer.
Responsibilities
A day in the life of a Research Compliance Auditor at Hackensack Meridian Health includes:
Collect, organize, review and analyze documentation related to research records and activities in the assigned research compliance area(s) to determine if institutional, state, and federal requirements are followed. This includes but is not limited to clinical billing, research study protocols, grant documents, and research agreements.
Prepare reports that identify areas of strength and/or needs improvement.
Track and monitor corrective and preventive action (CAPA) plans.
Ensure HMH’s research teams are “audit-ready” by performing mock FDA audits.
Serve as a specialist in the assigned areas and provide guidance to HMH researchers and staff.
Provide assistance in the development and implementation of policies and procedures for compliance with applicable policies and regulations.
Prepare annual written reports and metrics for various HMH Leadership and HMH’s Audit and Compliance Committee.
Independently conduct assigned research compliance audit work plan items.
Track and review updates to federal requirements in areas of research compliance with implications for HMH’s research enterprise including applicable laws, regulations, policies and guidance.
Must be resourceful and able to anticipate the requirements of a research study.
Other duties and/or projects as assigned.
Adheres to HMH Organizational competencies and standards of behavior.
Qualifications
Education, Knowledge, Skills and Abilities Required :
Bachelor’s degree from accredited college or university in a relevant area of study (e.g. physical sciences, public health, biomedical sciences.).
Minimum of 7 or more years of relevant professional experience in research administration and/or conducting research at an institution of higher education and/or academic medical center.
Experience working with research administration software solutions.
Basic understanding of research regulations and processes in at least one area of research compliance (e.g. human subjects research, clinical billing, FDA regulated research, sponsored research.)
Strong organization skills, ability to be proactive and ability to work both independently and as part of a team.
Skilled in making decisions based on critical and analytical thinking, experience and professional judgment.
Excellent written and verbal communication skills. Including confidence and comfortable with public speaking.
Proficient computer skills that may include but are not limited to Microsoft Office and/or Google Suite platforms.
Education, Knowledge, Skills and Abilities Preferred :
Relevant professional certifications (CIP, CHC, CHRC, CIPA, etc.)
5+ years of research audit experience
Job ID 2024-149035
Department Corporate Compliance
Site HMH Hospitals Corporation
Job Location US-NJ-Edison
Position Type Full Time with Benefits
Standard Hours Per Week 40
Shift Day
Shift Hours 8:30 am - 5:00 pm
Weekend Work No Weekends Required
On Call Work No On-Call Required
Holiday Work No Holidays Required