• Job Type: Officer of Administration
• Bargaining Unit: N/A
• Regular/Temporary: Regular
• End Date if Temporary: N/A
• Hours Per Week: 35
• Salary Range: Commensurate with experience

Position Summary

The Columbia Interventional Cardiovascular Care center is seeking a Clinical Research Coordinator to join our integrated research team of junior and senior Research Coordinators, Medical Assistants, Research and Regulatory Managers. The incumbent will play an integral role in the coordination and conduct of clinical trials.

Our physicians are world renowned and leaders in their field. They are engaged in research and work closely with our research team. The research we participate in is cutting edge, including first in man and early feasibility trials. We currently have upwards of 130 FDA regulated drug or device clinical trials in various cardiology disciplines including coronary, structural, peripheral, heart failure, nuclear, and electrophysiology. We offer great opportunities for learning and personal growth.

Responsibilities

• Responsible for reviewing new protocols, consent documents and budgets for operational and fiscal feasibility.
• In collaboration with the Regulatory Manager, ensures 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 ensures 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 onsite 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 escalates 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.
• Perform 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 for this position.

Other Requirements

• Participation in the medical surveillance program
• Contact with patients and/or human research subjects
• Potential bloodborne pathogen exposure
• Successful completion of applicable compliance and systems training requirements

Equal Opportunity Employer / Disability / Veteran

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