The Program Manager has the overall responsibility of managing the reporting, documentation and regulatory functions of the research group. The Program Manager will develop and/or execute existing standard operating procedures and other guidance documents and training material for staff. The Program Manager will submit and oversee the submission of regulatory filings with the New York State Psychiatric Institute Institutional Review Board (IRB); Data Safety Monitoring Boards (DSMB); federal clinical trials databases such as clinicaltrials.gov; the Food and Drug Administration (FDA, as in the case of new and ongoing INDs and IND Exemptions), and NIH. In addition, the Program Manager will be the Division's point of contact with both NYSPI and CU Human Resources for the hiring and onboarding of new staff. She/he will work closely with central administrative staff to administer the Division's finances, participate in the preparation of new federal and institutional grant applications, and work with Division PIs post-award to ensure the timely installation of study infrastructure and execution of grant tasks. The Program Manager will supervise clinical research staff alongside PI and Study Physicians.
The Program Manager will serve as the clinical expert for the team and provide clinical support to patients and clinical training to research staff.
Administrative: developing and maintaining standard operating procedures and other key documents and training material for use by members of the study team. Acting as POC with CU and RFMH HR Departments. Completing department orders and procurement forecasting.
Regulatory: completing and submitting, and overseeing the completion and submission of filings to NYSPI IRB, FDA, NIH, DSMB, ct.gov.
Grants: Post Award administration of Divisionâ€™s finances and participation in preparation of new federal and institutional grant applications; ensure the timely installation of study infrastructure and execution of grant tasks.
Staff supervision and training; back up clinical research testing and assessments as needed.
Bachelor's degree or equivalent in education and experience plus 3 years of related experience.
Previous experience with clinical trials coordination (preferably both administrative and clinical)
Must successfully complete online systems training requirements.
Involved with patients and/or research subjects.
At least 2-3 years previous experiencing managing clinical trials as a Senior Clinical Research Coordinator or Project Manager.
Prior experience working on NIH funded studies.
Ability to multitask effectively and manage multiple accountabilities with competing deadlines.
Minimum of 1-2 years experience managing clinical research spending, finances and procurement planning.
At least 2 years experience managing and supervising staff.
Equal Opportunity Employer / Disability / Veteran
Columbia University is committed to the hiring of qualified local residents.
Internal Number: 514596
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.