Job Listings

Protocol Review & Monitoring System Coordinator($2,000 Sign-On Bonus Available)

Company:
Weill Cornell Medicine
Job Location:
New York, New York
Category:
Laboratory and Research
Title: Protocol Review & Monitoring System Coordinator($2,000 Sign-On Bonus Available)  

Location: Upper East Side  

Org Unit: PRMS 

Work Days: Monday-Friday 

Exemption Status:  Exempt



Position Summary




Under general supervision, provides administrative and operational support to the Protocol Review and Monitoring System (PRMS) within the Meyer Cancer Center Clinical Trials Office (MCC CTO). 

This role is responsible for conducting preliminary reviews of DMT and PRMC applications to ensure completeness and compliance with committee requirements.  Incumbent determines level of PRMC review and whether research projects are exempt from further review. This role also serves as a liaison between investigators and study teams and provides training and guidance on DMT and PRMC policies and submission requirements. Further this role independently manages DMT and PRMC meetings along with the committee Chairs (faculty), guide discussions at the DMT meetings and assists committee members with deliberation.




Job Responsibilities

  • Provides day-to-day support to the MCC DMTs, PRMC and FRC. Serves as the central point person for committee members and research teams on PRMS related inquires.
  • Responsible for maintenance of cancer specific protocols, related data and reporting in OnCore. Runs clinical trial data reports.
  • Facilitates DMT, PRMC and FRC Meetings; creates meeting agendas, draft minutes, generates and disseminate correspondence/determination to the study teams. Ensures meetings appropriate representation and quorum.
  • Works closely with the DMT leaders, PRMC Chair and FRC Chair to address review concerns and serves as liaison between committee members and research teams.
  • Assists with the completion of the DMT application and organize all necessary research documents for DMT review. Assists with protocol presentations, as required.
  • Responsible for the preliminary review of application and documents submitted to the PRMC/FRC.
  • Maintains databases and related documents.
  • Assists with the development PRMS SOPs and workflows to ensure effective and efficient review of study protocols in accordance with the DMT and PRMC Charters.
  • Performs other related duties as assigned.

Education

  • Bachelor's Degree

Experience

  • Experience may be considered in lieu of a degree.
  • Approximately 2+ years of experience in a clinical research setting.
  • Knowledge of the Food and Drug Administration (FDA) and Office for Human Research Protections (OHRP) regulations.
  • Knowledge of International Conference on Harmonization (ICH) Good Clinical Practice (GCP) Guidelines.

Knowledge, Skills and Abilities

  • Self-motivated, detail-oriented, and able to work as part of a team.
  • Demonstrated strong communication and interpersonal skills; demonstrated ability to interact with multiple constituencies and exercise "people skills".
  • Demonstrated proficiency with MS Office Suite and database applications.
  • Demonstrated critical thinking and analytical skills.
  • Demonstrated ability to multi-task and prioritize in a fast-paced environment.
  • Demonstrated ability to remain focused despite frequent interruptions.
  • Ability to treat confidential information with utmost discretion.
  • Demonstrated ability to exercise standards of professionalism, including appearance, presentation and demeanor.
  • Demonstrated ability to work effectively in a collaborative manner with all departmental faculty and staff, as well as other institutional representatives.

Licenses and Certifications

  • SOCRA or ACRP certification preferred.

Working Conditions/Physical Demands




Standar.d office work




 

 

 

 

 

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.
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