Columbia University Irving Medical Center
Research Project Manager
Columbia University Irving Medical Center, New York, New York, us, 10261
Overview
Columbia University Irving Medical Center is seeking a qualified candidate for the full-time
Research Project Manager
role at the Stavros Niarchos Foundation (SNF) Center for Precision Psychiatry & Mental Health. The Research Project Manager will coordinate regulatory activities of research protocols, recruitment, data entry, and maintenance of study files and databases, and will report to the Principal Investigator. The position is based in New York City with study sites across the city.
Grade: 104
Hours Per Week: 35
Salary Range: $75,000 to $95,000
Responsibilities
Study Coordination and Regulatory Management
Coordinates the start-up and management of research studies 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 HIPAA 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 Equal Opportunity Employer / Disability / Veteran
Columbia University is committed to the hiring of qualified local residents.
Job function
Project Management and Information Technology
Industries
Hospitals and Health Care
#J-18808-Ljbffr
Research Project Manager
role at the Stavros Niarchos Foundation (SNF) Center for Precision Psychiatry & Mental Health. The Research Project Manager will coordinate regulatory activities of research protocols, recruitment, data entry, and maintenance of study files and databases, and will report to the Principal Investigator. The position is based in New York City with study sites across the city.
Grade: 104
Hours Per Week: 35
Salary Range: $75,000 to $95,000
Responsibilities
Study Coordination and Regulatory Management
Coordinates the start-up and management of research studies 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 HIPAA 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 Equal Opportunity Employer / Disability / Veteran
Columbia University is committed to the hiring of qualified local residents.
Job function
Project Management and Information Technology
Industries
Hospitals and Health Care
#J-18808-Ljbffr