Weill Cornell Medicine
Clinical Research Manager
This job is now closed
Job Description
- Req#: 87907
- Participates in the oversight and monitoring of investigator/coordinator compliance with IRB and institutional requirements and the approved protocol.
- Conducts site-initiation visits, routine and closed out visits to assure adherence to local and federal requirements.
- Conducts monitoring activities for Department's research clinical trials including pre-of source documentation to confirm subject eligibility, confirmation of informed consent and to validate accuracy and completeness.
- Responsible for identification of any serious adverse events and protocol deviations at the site; ensures that these are appropriately reported.
- Issues data query forms to the study team; anticipates, recognizes and resolves issues proactively with the site study team; provides the monitoring reports in detail for the regulatory files.
- Communicates with investigators and the study team, and ensure compliances with protocols, regulatory requirements, and good clinical practices; assists site personnel with internal audits or regulatory inspections.
- Assures that research regulatory documents are filed and maintained in accordance with FDA regulations, ICH guidelines, local regulations and SOPs.
- Serves as liaison between site personnel and the sponsor.
- Serves as the primary Clinical Research Coordinator/Monitor of pharmaceutical clinical trials in the department.
- Performs PFTs as a back for the research subjects of department
- Manages and monitors all aspects of the compliance with IRB and institutional requirements and the approved protocols.
- Manages all financial transactions related to subjects/patient care services, for accuracy and compliance.
- Performs the function of a Clinical Research Coordinator on all Pharmaceutical trials that are not in conflict with trials monitored under this role.
- Bachelor's Degree
Title: Clinical Research Manager
Location: Upper East Side
Org Unit: Administration
Work Days: Monday-Friday
Exemption Status: Exempt
Salary Range: $106,350.00 - $125,350.00
*As required under NYC Human Rights Law Int 1208-2018 - Salary range for this role when Hired for NYC Offices
Position Summary
Contributes to the management and oversight of clinical trials. Works closely with Principal Investigators (PI), Regulatory Affairs and Study Team to coordinate and ensure the successful completion of the clinical activities within the agreed timelines and budget, and in compliance with the required quality, Good Clinical Practice and ICH Guidelines. Overall, will coordinate activities related to clinical studies, monitor and document progresses. Serves as liaison between site personnel and the sponsor.
Job Responsibilities
Education
Experience
An academic degree in Life Sciences and good knowledge of good clinical practice and local regulations.
Minimum of five years with on-site monitoring activities
Experiences with FDA Audit and/or Federal Regulatory agencies preferred
Extensive technical knowledge of the functioning of IBCs, DSMBs and IRBs, including extensive knowledge of the technical requirements of the federal regulations that govern human subjects research, adverse events reporting, state laws governing research, and WCMC policies
Comprehensive and practical knowledge of the principle of clinical trial conduct in accordance with ICH/GCP and other clinical trials-related regulations or guidelines
Thorough knowledge of clinical development processes and conduct of clinical studies.
Knowledge, Skills and Abilities
- Excellent communication skills.
- Strong analytical and problem solving skills.
- Demonstrated organizational skills and ability to pay close attention to detail.
- Dependable, self-motivated and able to work with minimal supervision.
- Good computer skills.
Licenses and Certifications
- Certification with CCRP and/or CCRA preferred.
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 race, sex, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, or genetic information.