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Clinical Research Compliance Manager
| Company | Weill Cornell Medicine |
| Address | , New York, 10022, Ny |
| Employment type | |
| Salary | $101,600 - $125,400 a year |
| Expires | 2023-10-07 |
| Posted at | 8 months ago |
Title: Clinical Research Compliance Manager
Title: Clinical Research Compliance Manager
Location: Midtown
Org Unit: General Operations
Work Days:
Exemption Status: Exempt
Salary Range: $101,600.00 - $125,400.00
- As required under NYC Human Rights Law Int 1208-2018 - Salary range for this role when Hired for NYC Offices
Position Summary
Works independently on managing and overseeing the audit and monitoring program within the Quality Assurance Unit (QAU), central subject registration processes and electronic Informed Consent systems and guidelines. This role works collaboratively with the Human Research Protections Program to meet the requirements for AHRPP accreditation as well as the Meyer Cancer Center for NCI designation.
Job Responsibilities
- Develops and implements an institutional audit and monitoring program for human subjects' research to ensure compliance and protocol adherence for studies performed at Weill Cornell Medicine and NewYork-Presbyterian, including the Network hospitals.
- Recruits, hires, and provides direct management and training of clinical research compliance team. Accompanies staff to audits and monitoring visits, as necessary.
- Performs other duties as assigned or required.
- Collaborates with Cancer Clinical Trials Office audit program and with directors and staff within WCM to meet NCI designated Cancer Center standards. Collaborates with Human Research Protections Program to ensure adherence to AHRPP requirements.
- Oversees central subject registration processes. Develops QA processes and ensures timely registration of participants. Validates informed consent documents are appropriately executed and provides follow-up education and training, as necessary.
- Develops, implements and maintains Standard Operating Procedures and guidance documents for the conduct of routine audits. Develops training programs consistent with organizational needs and in accordance with current Good Clinical Practice requirements.
- Plans, coordinates, and implements process improvements and methods to ensure compliance to internal and external quality standards at Weill Cornell Medicine and NewYork-Presbyterian.
- Ensures adherence to institutional policies and federal regulations for study activation, maintenance, and conduct.
- Manages electronic consent processes with clinical research compliance team. Ensures compliance to institutional policies and federal regulations. Develops SOPs and guidance documents to assist study teams in creating and utilizing eConsents.
Education
- Bachelor's Degree
Experience
Approximately five years of prior experience in a clinical research setting.
Knowledge, Skills and Abilities
- Ability to treat confidential information with utmost discretion.
- Demonstrated knowledge of database, word processing, and spreadsheet programs.
- Demonstrated ability to work effectively in a collaborative manner with all departmental faculty and staff, as well as other institutional representatives.
- Demonstrated ability to remain focused despite frequent interruptions.
- Demonstrated critical thinking and analytical skills.
- Demonstrated organizational skills and ability to pay close attention to detail.
- Demonstrated proficiency with MS Office Suite and REDCap.
- Demonstrated ability to multi-task and prioritize in a fast-paced environment.
- Demonstrated ability to exercise standards of professionalism, including appearance, presentation and demeanor.
Licenses and Certifications
Working Conditions/Physical Demands
Weill Cornell Medicine is a comprehensive academic medical center that's committed to excellence in patient care, scientific discovery, and the education of future physicians 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, 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 race, sex, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, or genetic information.
Nearest Major Market: Manhattan
Nearest Secondary Market: New York City
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