Job Listings

Clinical Trials Coordinator

Company:
Weill Cornell Medicine
Job Location:
New York, New York
Category:
Laboratory and Research
Title: Clinical Trials Coordinator

Location: Upper East Side

Org Unit: Research Support

Work Days:

Exemption Status: Non-exempt

Position Summary

Under general direction, the Clinical Trials Coordinator is responsible for all aspects of clinical trial processes from study submission through closeout, clinical trial conduct, subject coordination, data management, regulatory start-up and maintenance and budget negotiation.

Job Responsibilities
  • Prepares and submits protocol-related documents to the IRB and other applicable committees for initial submission, annual continuing review and amendment approvals. Reports protocol deviations and safety events in accordance with IRB and sponsor policy.
  • Ensures completion of essential clinical trials documents, including but not limited to study staff CVs, licenses, FDA form 1572, financial disclosures, GCP training and delegation logs.
  • Oversees study team certification and preparedness prior to study initiation.
  • Reviews and modifies budget according to institutional guidelines. Works closely with the sponsor and the Joint Clinical Trials Office towards finalizing the budget.
  • Participates in subject recruitment. Assesses subject eligibility and oversees the informed consent process.
  • Educates study subjects, their families, and other health care providers on what is expected from them during the duration of the clinical trial.
  • Coordinates the pre-trial and follow-up medical visits and procedures required of each study protocol.
  • Ensures that research information is collected and stored in a manner that is compliant with regulations/policies and good clinical practice.
  • Collects and processes study specimens. Maintains appropriate certification to package and ship specimens to the sponsor or laboratory in accordance with sponsor guidelines and regulations.
  • Ensures investigational drugs/devices are stored according to sponsor specifications.
  • Coordinates and participates in site visits and audits. Ensures readiness and compliance. Addresses and resolves issues uncovered during visit/audit.
  • Maintains inventory of supplies, equipment and/or reagents. May order supplies/equipment/reagents as authorized or ensure that needs are escalated appropriately. Receives supply orders and confirms accuracy of delivery. May assist with cost control.
  • Ensures that facilities and equipment are in optimal and proper working condition. Coordinates preventative maintenance and repairs as needed. May perform minor repairs if qualified and as needed. May advise on upgrades for performance enhancements.
Education
  • High School Diploma
Experience
  • Bachelor's degree preferred.
  • Approximately 2 years of experience in health-related role, in clinical or research setting
Knowledge, Skills and Abilities
  • Experience with regulatory, data management, and billing compliance aspects of clinical research.
  • Experience with conducting and carrying out protocols and research coordination.
  • Familiarity with IRB interaction, regulatory policies, database input and report generation.
  • Research experience in an academic health center with exposure to a team research environment at all levels (senior investigators, nurses, research coordinators, lab technicians.
Licenses and Certifications

Working Conditions/Physical Demands

Standard 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.
This website is part of the HigherEdJobs network.