Job Listings

Trial Manager

Company:
Weill Cornell Medicine
Job Location:
New York, New York
Category:
Laboratory and Research
Title: Trial Manager

Location: Upper East Side

Org Unit: Clinical Trials - Urology

Work Days: Monday-Friday

Exemption Status: Exempt

Position Summary

Oversees the projects for the duration of the grant, including general day-to-day administrative management and project oversight; spearheads team development and cohesion, and implements plans for strategic advancement. This role oversees all aspects of clinical research projects by planning, implementing, and managing the process involved.

Job Responsibilities
  • Provides day-to-day supervision to the project team. Facilitates communication between principal investigator, administration, sponsor and team members to ensure project cohesion.
  • Assists with development and implementation of project clinical research SOPs. Develops quality maintenance plans to routinely analyze/evaluate workflows and to initiate new policies/procedures for continued quality improvement and overall program growth.
  • Manages and trains all project clinical trial coordinators/assistants. Provides guidance on proper research conduct. Ensures study goals are achieved. Identifies areas of improvement and carries out action plans to improve performance in targeted areas.
  • Manages highly-complex and stringently-regulated clinical research protocols. Oversees patient consenting, data collection, record management and regulatory compliance. Reports findings to leadership.
  • Spearheads subject recruitment and retention for enrolling studies. Oversees the development, implementation and execution of recruiting and retention campaigns.
  • Consults with principal investigator on project development and execution, including IRB protocol startup and continued compliance. Tracks approval process and ensures all deadlines are met.
  • Serves as a liaison to various WCM clinical trials departments/offices, to ensure team compliance to Good Clinical Practice as well as adherence to WCM policies and funding agency regulations.
  • Assists with draft preparation of study-related budgets for project funding agencies.
  • Collaborates with grants administrator(s) to track finances and manage the financial activity of grant portfolios, including pre- and post-award grant management activities. Regularly reports to leadership on these activities.
  • Collaborates with principal investigator and the clinical research team to manage study reporting to study sponsor.
  • Works closely with sponsor, site and study personnel on regulatory issues. Develops policies and procedures pertaining to regulatory and monitoring processes for clinical studies. Leads regulatory educational training events for personnel at various sites.
  • Develops regulatory reports and associated documentation in accordance with SOPs and study specific processes.
Education
  • Bachelor's Degree
Experience
  • Approximately 2 years experience in clinical research field.
  • Experience with regulatory, data management, budgeting and billing compliance aspects of clinical research. Knowledge of FDA regulations governing clinical research.
  • Prior supervisory experience preferred.
  • Experience in developing business and strategic plans for new programs and program growth highly desired.
Knowledge, Skills and Abilities
  • Ability to foster smooth communications and teamwork among clinical research faculty, fellows and staff as well as external organizations (sponsors and contract research organizations).
  • Proficiency in MS Office, specifically word processing (Word), spreadsheets (Excel) and database applications.
  • Excellent organizational, oral and written communication skills.
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 New York-Presbyterian Hospital/Weill Cornell Medical Center, New York-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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