Job Description
Research Compliance Specialist Title: Research Compliance Specialist
Location: Upper East Side
Org Unit: Billing & Compliance
Work Days: Monday-Friday
Weekly Hours: 35.00
Exemption Status: Exempt
Salary Range: $76,800.00 - $87,600.00
*As required under NYC Human Rights Law Int 1208-2018 - Salary range for this role when Hired for NYC Offices
Position Summary Responsible for planning and execution of audit matters related to research efforts and other quality improvement initiatives.
Job Responsibilities - Responsible for planning and conducting both routine and for-cause audits, to ensure adherence to local and federal requirements.
- Issues audit reports providing comprehensive evaluation of audit findings, including both proposing and assessing corrective and preventative action plans, conducting trend analysis and making training proposals to investigators.
- Develops and implements appropriate standard operating procedures (SOP) for the Data and Safety Monitoring Board and audit committee.
- Responsible for managing and maintaining the institution's ClinicalTrials.gov account, including providing account access, reviewing and approving registrations and updates submitted by Investigators and study teams.
- Manages Immediate Reports operations and reporting; including pre-review of all submissions and requesting additional information as required; liaises with IRB and investigators to propose corrective and preventative action plans.
- Responsible for independently conducting and reporting Joint Commission quality assurance audits of research subject consent records.
- Develops metrics/reports to monitor strategic goals & initiatives for all areas of Human Research Compliance. Reports on this data on a regular basis.
- Assists with compliance training initiatives, including coordinating educational sessions, writing and editing compliance manuals and developing presentations.
- Performs other related duties as assigned.
Education Experience Bachelor's Degree in healthcare or biological sciences preferred.
Approximately 5-7 years progressive experience in quality assurance or IRB.
Extensive knowledge of and proven experience with implementing federal and industry regulations that govern human subject research protections.
Experience with, or direct knowledge of, several quality system elements (e.g. document management, complaint investigation, CAPA, risk-based monitoring) is preferred.
Advanced knowledge of Microsoft Office Suite, Redcap, Adobe is highly desired.
Knowledge, Skills and Abilities - Excellent communication skills (both verbal and written).
- Strong problem solving and decision making skills and the ability to make decisions independently.
- Ability to take initiative and simultaneously manage multiple projects with minimal supervision.
Licenses and Certifications Working Conditions/Physical Demands Weill Cornell Medicine is a comprehensive academic medical center that is committed to excellence in patient care, scientific discovery, and the education of future physicians and scientists in New York City and around the world. Our doctors and scientists - faculty from Weill Cornell Medical College, Weill Cornell Graduate School of Medical Sciences, and the Weill Cornell Physician Organization - are engaged in world-class clinical care and cutting-edge research that connect patients to the latest treatment innovations and prevention strategies. Located in the heart of the Upper East Side's scientific corridor, Weill Cornell Medicine's powerful network of collaborators extends to its parent university Cornell University; to Qatar, where an international campus offers a U.S. medical degree; and to programs in Tanzania, Haiti, Brazil, Austria and Turkey. Our medical practices serve communities throughout New York City, and our faculty provide comprehensive care at NewYork-Presbyterian Hospital/Weill Cornell Medical Center, NewYork-Presbyterian/Lower Manhattan Hospital, NewYork-Presbyterian Hospital/Brooklyn Methodist Hospital, NewYork-Presbyterian Hospital/Westchester Behavioral Health Center, and NewYork-Presbyterian/Queens. At Weill Cornell Medicine, we work together to treat each individual, not just their conditions or illnesses, as we strive to deliver the finest possible care for our patients - the center of everything we do. Weill Cornell Medicine is an Equal Employment Opportunity Employer. Weill Cornell Medicine provides equal employment opportunities to all qualified applicants without regard to protected status, including race, sex, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, or genetic information.
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About Weill Cornell Medicine
Weill Cornell Medicine is a global healthcare leader known for the world-class patient care, cutting-edge research and top-ranked education. Every day, the employees of Weill Cornell Medicine improve lives across the city and around the globe. They help patients stay well, and our benefits and programs aim to help our employees and their families stay well by supporting their physical, financial, and professional health.
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Job Tags
Local area, Immediate start, Monday to Friday,