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.
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.
Bachelor's degree or equivalent in education, training and experience, plus three years of related experience.
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.
Internal Number: 512365
About Columbia University
Columbia University is one of the world's most important centers of research and at the same time a distinctive and distinguished learning environment for undergraduates and graduate students in many scholarly and professional fields. The University recognizes the importance of its location in New York City and seeks to link its research and teaching to the vast resources of a great metropolis. It seeks to attract a diverse and international faculty and student body, to support research and teaching on global issues, and to create academic relationships with many countries and regions. It expects all areas of the university to advance knowledge and learning at the highest level and to convey the products of its efforts to the world.