Advertised Summary Job Description: Reports to the Research Director of the Transplant Clinical Research Center (TCRC). As a member of the TCRC Team, conducts and/or prepares for internal and external regulatory reviews for clinical research. Research projects may involve multi-centered cooperative group studies, single site studies, intergroup studies, industry studies, and investigator initiated studies. The individual who holds this position acts in accordance with all local, state, federal and CUMC IRB policies and procedures. Position Responsibilities: 1 Adheres to the policies, procedures, and guidelines instituted by the TCRC, CUMC Office of the Executive Vice President for Research, CUMC Human Research Protection Office, and the CUMC IRB.
2 Works closely with the TCRC Research Director & additional Regulatory Coordinator to ensure Standard Operating Procedures (SOPs) are implemented and documented in accordance within TCRC, study sponsor, Principal Investigator, and regulatory agency specifications.
3 Serves as a regulatory contact for studies; ensures that regulatory compliance is met and that regulatory files are audit-ready.
4 Determines and interprets applicable rules and regulations associated with complex clinical research studies and trials involving human subjects ensuring the protection of their safety, rights, and welfare.
5 Works closely with the TCRC Research Director and study research coordinators to coordinate study start-up activities, which involves collection and distribution of regulatory, and coverage analysis documents.
6 Coordinates submissions to ancillary committees as applicable per study protocol.
7 Communicates with the IRB and study sponsor on behalf of the study team regarding regulatory management.
8 Monitors email and to ensure that study documents are up to date and implemented in a timely fashion.
9 Work along with TCRC Research Director and study research coordinator to communicate with study team to ensure implementation of amendments, awareness of safety, and protocol changes and document version control. This includes attendance at research team meetings.
10 Finalizes documents based on IRB comments and recommendations and ensures IRB approval of study.
10 Reports regulatory activity to the study team at team meetings.
11 Maintains accurate records related to all the regulatory research for TCRC clinical studies and trials.
12 Assists Research Coordinators in developing Source Document templates (if applicable) for studies by completing comparison review of source document template against protocol schedule of activities and EDC snapshots. Helps to ensure that Source Documentation includes all data items required for all visits prior to enrollment of first subject and works with research coordinators to update Source Document template throughout the study.
13 Proactively, conducts weekly review of data queries generated from data entry into EDC and reports information to TCRC Research Director. Works Research Coordinators to resolve queries in timely manner.
14 Ensures timely reporting of Unanticipated Problems.
15 Prepares regulatory files for audits and local monitoring visits.
16 Updates databases for reporting requirements.
17 Performs other duties as assigned.
General Minimum Qualifications: Bachelor's degree required;
Additional Specific Minimum Qualifications: Bachelor's degree in Health Sciences preferred.
One to three years of experience in the academic or pharmaceutical clinical trials environment preferred.
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.