Research Compliance Specialist

at  Weill Cornell Medicine

TITLE: 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.

EDUCATION

• Bachelor’s Degree

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.

• 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.