Research Project Manager

The salary of the finalist selected for this role will be set based on a variety of factors, including but not limited to departmental budgets, qualifications, experience, education, licenses, specialty, and training. The above hiring range represents the University's good faith and reasonable estimate of the range of possible compensation at the time of posting.

Position Summary

Stavros Niarchos Foundation (SNF) Center for Precision Psychiatry & Mental Health is seeking a qualified candidate to fill a full-time position of Research Project Manager who will be responsible for coordinating regulatory activities of research protocols, recruitment, data entry, and maintenance of study files and databases.

Responsibilities

The Research Project Manager will report to Principal Investigator and coordinate a research study taking place at several sites throughout New York City. The Research Project Manager will be responsible for coordinating regulatory activities of research protocols, recruitment, data entry, and maintenance of study files and databases.

Specific responsibilities will include

Study Coordination and Regulatory Management :

• Coordinates the start-up and management of research study including IRB submissions and preparing / maintaining protocol-specific regulatory documents for study initiation, implementation, ongoing monitoring, and study closure.
• Coordinates with staff across multiple study sites regarding participant eligibility, recruitment, consent, and sample handling.
• Collaborate with Investigators to provide leadership, counsel and assistance in implementing, managing and sustaining the ongoing study protocol.
• Identify operational and / or protocol issues, discuss with the Investigators and implement and oversee fulfillment of solutions.
• Work with Investigators to ensure compliance with informed consent, identify, report and resolve adverse events and HIPPA compliance.
• Maintains quality assurance and control, including adherence to regulatory requirements.
• Reviews and supports PI in the development of study protocols. Coordinates protocol submissions to the Clinical Trials Office, Protocol Review and Monitoring Committee, Data and Safety Monitoring Committee, Fiscal Support Committee, and Institutional Review Board.
• Administration and collection of questionnaires and data.
• Maintain research study supply inventory.
• Prepares for and contributes to meetings with PIs, sponsors, and study teams throughout the medical center, cancer center, and other clinical departments.
• Generate and perform queries to monitor study milestones and evaluate overall study progress.

Data Coordination

• Conducting comprehensive medical record review for subject screening and recruitment, ascertainment, and obtaining written informed consent from participants, family members, and legally appointed guardians.
• Reviews and follows research protocols and determines data management requirements. Responsible for data entry requirements for each patient enrolled.
• Oversee management of research databases, conduct systematic audits of databases to ensure data quality, accuracy, and regulatory compliance.

Minimum Qualifications

• Bachelor's degree or equivalent in education and experience required; plus, three years of related experience.

Preferred Qualifications

• Experience as a clinical research manager / coordinator.
• Experience supervising and management of clinical study team.

OTHER REQUIREMENTS :

• Demonstrated ability to write informed consent form documents.
• Experience with central and local IRB submissions.
• Ability to interpret and apply regulatory requirements.
• Must be flexible, highly organized, and able to manage a complex study.
• Ability to communicate, interpret, share and present information to management and research investigators and staff.
• Computer proficiency.
• Experience with data collection.
• Ability to work both independently and collaboratively within an integrated team.

Equal Opportunity Employer / Disability / Veteran

Columbia University is committed to the hiring of qualified local residents.