What are the responsibilities and job description for the Clinical Research Manager position at Weill Cornell Medicine?
Title: Clinical Research Manager
Location: Upper East Side
Org Unit: Neurological Surgery
Work Days
Weekly Hours: 35.00
Exemption Status: Exempt
Salary Range: $106,350.00 - $125,350.00
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
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, preferably in genetics medicine and pulmonary medicine.
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
Cornell welcomes students, faculty, and staff with diverse backgrounds from across the globe to pursue world-class education and career opportunities, to further the founding principle of "any person, any study." No person shall be denied employment on the basis of any legally protected status or subjected to prohibited discrimination involving, but not limited to, such factors as race, ethnic or national origin, citizenship and immigration status, color, sex, pregnancy or pregnancy-related conditions, age, creed, religion, actual or perceived disability (including persons associated with such a person), arrest and/or conviction record, military or veteran status, sexual orientation, gender expression and/or identity, an individual's genetic information, domestic violence victim status, familial status, marital status, or any other characteristic protected by applicable federal, state, or local law.
Cornell University embraces diversity in its workforce and seeks job candidates who will contribute to a climate that supports students, faculty, and staff of all identities and backgrounds. We hire based on merit, and encourage people from historically underrepresented and/or marginalized identities to apply. Consistent with federal law, Cornell engages in affirmative action in employment for qualified protected veterans as defined in the Vietnam Era Veterans' Readjustment Assistance Act (VEVRRA) and qualified individuals with disabilities under Section 503 of the Rehabilitation Act. We also recognize a lawful preference in employment practices for Native Americans living on or near Indian reservations in accordance with applicable law.
To apply, visit https://jobs.weill.cornell.edu/NY/job/New-York-Clinical-Research-Manager-NY-10065/1376539400/
Copyright ©2025 Jobelephant.com Inc. All rights reserved.
Posted by the FREE value-added recruitment advertising agency
jeid-91c8cb1b042b2a4ebcd81e9f43de11cb
Location: Upper East Side
Org Unit: Neurological Surgery
Work Days
Weekly Hours: 35.00
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
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
- 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
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, preferably in genetics medicine and pulmonary medicine.
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.
- Certification with CCRP and/or CCRA preferred.
Cornell welcomes students, faculty, and staff with diverse backgrounds from across the globe to pursue world-class education and career opportunities, to further the founding principle of "any person, any study." No person shall be denied employment on the basis of any legally protected status or subjected to prohibited discrimination involving, but not limited to, such factors as race, ethnic or national origin, citizenship and immigration status, color, sex, pregnancy or pregnancy-related conditions, age, creed, religion, actual or perceived disability (including persons associated with such a person), arrest and/or conviction record, military or veteran status, sexual orientation, gender expression and/or identity, an individual's genetic information, domestic violence victim status, familial status, marital status, or any other characteristic protected by applicable federal, state, or local law.
Cornell University embraces diversity in its workforce and seeks job candidates who will contribute to a climate that supports students, faculty, and staff of all identities and backgrounds. We hire based on merit, and encourage people from historically underrepresented and/or marginalized identities to apply. Consistent with federal law, Cornell engages in affirmative action in employment for qualified protected veterans as defined in the Vietnam Era Veterans' Readjustment Assistance Act (VEVRRA) and qualified individuals with disabilities under Section 503 of the Rehabilitation Act. We also recognize a lawful preference in employment practices for Native Americans living on or near Indian reservations in accordance with applicable law.
To apply, visit https://jobs.weill.cornell.edu/NY/job/New-York-Clinical-Research-Manager-NY-10065/1376539400/
Copyright ©2025 Jobelephant.com Inc. All rights reserved.
Posted by the FREE value-added recruitment advertising agency
jeid-91c8cb1b042b2a4ebcd81e9f43de11cb
Salary : $106,350 - $125,350