Advertised Summary Job Description: The successful candidate will play an integral role in the coordination and conduct of precision medicine and human genetic research studies, including clinical trials. He/she will review new protocols, consent documents and budgets for operational and fiscal feasibility and work in collaboration with the principal investigator and project manager/genetic counselor on all study related activities. The incumbent will 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. He/she will obtain informed consent and/or oversee informed consent process from research subjects prior to any study-related procedures. The individual will be responsible for collecting data and completing case report forms appropriately. He/she will establish internal and external relationships with local physicians and clinical teams, prepares recruitment plans and revise as necessary to meet target enrollment goals. The selectee will ensure that pertinent tests, procedures and lab work are completed. The Clinical Research Coordinator will coordinate the clinical research protocol dictated follow-ups. He/she will interact appropriately with sponsors, data coordinating centers and core laboratory personnel as needed. The successful candidate will 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. The desired candidate should understand the clinical process, attend compliance training programs, participate in investigator meetings and site initiations. He/she will practice GCP and FDA/HHS regulations, fulfill regulatory and reporting requirements for clinical research protocols. The incumbent will be responsible for complying with Columbia University and Hospital policies and procedures related to Clinical Research. The selectee will perform other responsibilities as needed.
General Minimum Qualifications: Requires a bachelor's degree or equivalent in education, training and experience, plus three years of related experience.
Additional Specific Minimum Qualifications: Previous experience in IRB-Consenting and human clinical studies, human genetic studies or clinical trials is required for this position.
As a member of the National Collegiate Athletic Association (NCAA) and the Council of Ivy Group Presidents (Ivy League), it is imperative that members of the Columbia University community, in all matters related to the intercollegiate athletics program, exhibit the highest professional standards and ethical behavior with regard to adherence to NCAA, Conference, University, and Department of Intercollegiate Athletics and Physical Education rules and regulations.
Columbia University is an Equal Opportunity/Affirmative Action employer.
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.