Advertised Summary Job Description: The Regulatory Coordinator will work with investigators, study staff, Institutional Review Boards (IRB), clinical trial sponsors and federal regulatory agencies to ensure that regulatory requirements for clinical trials are met.
Responsibilities include: -Completion and submission of new clinical trials applications to the IRB; -writing plain language informed consent documents; - tracking and facilitating the progress of new trials through the review process -correspondence with the IRB, investigators and sponsors throughout the review process - participation in internal and external audits -collection, completion, and submission of regulatory documents to various regulatory entities -creation and maintenance of regulatory binders and other relevant files during the review, approval, and activation process for new trials. - coordinate study agreements and budgets with Pediatric Research Administration, Clinical Trials Office, and the sponsor. -The candidate will be expected to work on multiple projects and have excellent rapport with participants and other staff at the Center. -The candidate will perform assist with data entry and other related duties as assigned
General Minimum Qualifications: Requires a bachelor's degree or equivalent in education and experience, plus three years of related experience.
Additional Specific Minimum Qualifications: - Experience in clinical trials/research - Effective communication and writing skills - The incumbent is required to have strong organizational and interpersonal skills. - Proficient in Microsoft Office (Outlook, Word, Excel, and Access) and Internet.
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.