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CURRENT OPPORTUNITIES

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Program Manager

  • Requisition no: 514596
  • Work type: Full Time
  • Location: Medical Center
  • School/Department: Psychiatry
  • Grade: Grade 104
  • Categories: General Administration
  • Job Type: Officer of Administration
  • Bargaining Unit:
  • Regular/Temporary: Regular
  • End Date if Temporary:
  • Hours Per Week: 35
  • Salary Range: Commensurate with experience
 

Position Summary

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.

 


Responsibilities

  • 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 Division’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.

Minimum Qualifications

  • Bachelor's degree or equivalent in education and experience plus 3 years of related experience.

Preferred Qualifications

  • Master's degree 
  • Previous experience with clinical trials coordination (preferably both administrative and clinical)


Other Requirements

  • 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.

Applications open: Eastern Daylight Time
Applications close:

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