Clinical Research Coordinator I - Cardiology

• Job Type: Officer of Administration
• Regular/Temporary: Regular
• Hours Per Week: 35
• Salary Range: Commensurate with experience

Position Summary

The Clinical Research Coordinator I will play an integral role in the coordination and conduct of precision medicine and human genetic research studies, including clinical trials.

Responsibilities

• Review new protocols, consent documents and budgets for operational and fiscal feasibility

• Work in collaboration with the principal investigator and project manager/genetic counselor on all study related activities.

• Explain the clinical research protocol to patients and their families in a manner that is easily understood and ensures that their questions are answered appropriately.

• Obtain informed consent and/or oversee informed consent process from research subjects prior to any study-related procedures.

• Collect data and complete case report forms appropriately. 

• Establish internal and external relationships with local physicians and clinical teams

• Prepare recruitment plans and revise as necessary to meet target enrollment goals.

• Ensure that pertinent tests, procedures and lab work are completed.

• Coordinate the clinical research protocol dictated follow-ups.

• Interact appropriately with sponsors, data coordinating centers and core laboratory personnel as needed.

• Ensure that regulatory binders are complete and up-to date and ensure protocol events (modifications, renewal, unanticipated problems, terminations) are submitted to the IRB with approval documentation in place.

• Understand the clinical process, attend compliance training programs, participate in investigator meetings and site initiations.

• Practice GCP and FDA/HHS regulations and fulfill regulatory and reporting requirements for clinical research protocols.

• Comply with Columbia University and Hospital  policies  and procedures related to Clinical Research.

• Perform other responsibilities as needed.

Minimum Qualifications

• Bachelor's degree or equivalent in education, training and experience, plus three years of related experience.

Other Requirements

• Previous experience in IRS-Consenting and human clinical  studies, human genetic  studies  or clinical  trials.  
• 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.