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Clinical Research Coordinator - Cardiology

Medicine

Clinical Research Coordinator - Cardiology

  • 532901
  • Medical Center
  • Medicine
  • Full Time
  • Opening on: Dec 21 2022
  • Grade 103
  • Job Type: Officer of Administration
  • Bargaining Unit: N/A
  • Regular/Temporary: Regular
  • End Date if Temporary: N/A
  • Hours Per Week: 35
  • Salary Range: $58,500 Annual - $68,000 Annual
The salary of the finalist selected for this role will be set based on a variety of factors, including but not limited to departmental budgets, qualifications, experience, education, licenses, specialty, and training. The above hiring range represents the University's good faith and reasonable estimate of the range of possible compensation at the time of posting.
 

Position Summary

The Clinical Research Coordinator will play an integral role in the coordination and conduct of clinical trials.


Responsibilities

  • Review new protocols, consent documents and budgets for operational and fiscal feasibility.
  • In collaboration with the Regulatory Manager, ensure start up regulatory documents are completed, signed as appropriate and provided to the sponsor
  • Participate in pre-study, initiation, monitoring and close out visits.
  • In collaboration with the Clinical Manager, organize roll out and training of new studies within interdisciplinary teams.
  • Communicate protocol amendments to appropriate parties and ensure training is complete as required.
  • Establish internal and external relationships with local physicians and clinical teams.
  • Prepare recruitment plans and revise as necessary to meet target enrollment goals.
  • Screen for eligibility by reviewing medical record source documents, inclusion/exclusion criteria, and subjects' willingness and capability to follow required clinical research procedures, processes, and follow up appointments.
  • Obtain informed consent and/or oversee informed consent process from research subjects prior to any study-related procedures.
  • Ensure all aspects of the research study are carried out in accordance with the IRB-approved protocol, institutional policy, FDA regulations and GCP guidelines.
  • Ensure follow up visits are scheduled within window and all necessary study related procedures are conducted according to the protocol.
  • Oversee maintenance of the screening/enrollment log and study manager.
  • Ensure appropriate reporting and documentation of protocol deviations and exemptions as well as development and implementation of corrective action plans for review by the Clinical Manager and Administrative Director as needed.
  • In collaboration with the Regulatory Manager, ensure protocol events (modifications, renewal, unanticipated problems, terminations) are submitted to the IRB and approval documentation is in place.
  • Ensure appropriate data is abstracted from medical records, clinic, consultation, and referral notes to study forms and recorded accurately onto case report forms; ensure appropriate maintenance of source documentation for all case report entries.
  • Ensure all data queries are resolved.
  • Meet regularly with investigator and research team to discuss subject participation and study progress.
  • Communicate all protocol-related issues to appropriate study personnel or manager.
  • Attend study specific on-site meetings, Investigator meetings, conference calls and monthly CRC meetings as required or asked to do so.
  • Apprise principal investigator, of all study specific medical issues for guidance.
  • Apprise Research Director and Clinical Manager of all study-specific operations and/or compliance issues.
  • Review and respond to any data queries or monitoring and auditing findings and escalate issues to Clinical Manager as necessary.
  • Assure the maintenance of accurate and complete records including regulatory documents, signed informed consent forms, source documentation, drug dispensing logs, device utilization logs, subject logs, and study-related communications.
  • Track and report as applicable adverse events, serious adverse events, protocol waivers, deviations, and violations.
  • Performs other duties as assigned.

 


Minimum Qualifications

  • Requires a bachelor's degree or equivalent in education, training, and experience, plus two years of related experience.

Preferred Qualifications

  • Previous experience in Clinical Trials is preferred.

Other Requirements

  • Participation in Medical Surveillance Program.
  • Must successfully complete systems training requirements.

Equal Opportunity Employer / Disability / Veteran

Columbia University is committed to the hiring of qualified local residents.

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