Clinical Project Coordinator

• Job Type: Officer of Administration
• Bargaining Unit:
• Regular/Temporary: Regular
• End Date if Temporary:
• Hours Per Week: 35
• Standard Work Schedule:
• Building:
• Salary Range: $62,400.00 - $65,00.00

Position Summary

The Clinical Project Coordinator (CPC) will be working with Principal Investigators to coordinate multi-center research studies of Parkinson's Disease, Alzheimer's disease, and possibly other neurological/psychiatric diseases. The CPC is an essential member of the research team.

Responsibilities

Responsibilities include but are not limited to:

Clinical:

• Identify, recruit, and consent eligible participants; conduct visits as outlined in study protocols and accordance with Good Clinical Practices (GCP) and HIPAA guidelines.
• Perform research-related services, such as coordinating study visits, scheduling study visits, data collection, data entry, and transmission.
• Perform research visits, including study questionnaires and patient assessments.
• Collect data and complete case report forms for all study visits through research visits, chart abstraction, or telephone, as required by the protocol and consistent with GCP, HIPAA, FDA/HHS, and state and institutional regulations.
• Responsible for collecting, transporting, processing, and shipping blood samples in accordance with federal, state, and institutional policies.
• Create, prepare, and maintain research protocols for the Institutional Review Board (IRB) to ensure compliance with research and ethical requirements; report to IRB regarding research-related changes or events.
• Interface with various hospital departments and additional centers for material such as medical records, the CTSA, the IRB/HRPO, and others as needed.
• Coordinate protocols and human subject approvals between various sites.

Research:

• Create and maintain patient research records. Enter research data into study-specific electronic databases.
• Coordinate research data collection between multiple sites.
• Conduct basic statistical analysis; assist with the preparation of study publications and presentations.

Grant:

• Assist PI in drafting and preparing all grant applications (clinical, non-clinical, basic, etc.)
• Collaborate with PI, internal and external departments and divisions to create categorized budgets and justifications. Confirms accuracy and completeness of all budgeted costs.
• Partner with OSP, SPA, Finance, Division Administrator for all grant submissions and matters.
• Track award financial and progress milestones.
• Connect with appropriate team/department to fulfill such requirements and remain compliant with award terms and conditions.
• Assist PIs in preparing new protocol submissions, protocol amendments, and renewals of ongoing studies.
• Collaborate with PIs to prepare IRB/HRPO and any other regulatory submission documents as required by the protocol.
• Prepare, establish, and organize other study materials. These study materials include but are not limited to, the informed consent document, case report forms (CRFs), and enrollment logs.

Project Coordination and Management:

• Coordinate research projects across various performance sites; ensure research compliance with sponsor requirements and timely submission of progress reports.
• Coordinate regular meetings for administrative, grants, and scientific updates. Track research progress and data and resource sharing among research networks.
• Ensure that all aspects of a project are organized and in conformance with timeline and deliverables requirements.
• Report project risks and outcomes to appropriate management channels and escalate issues according to project work plan.
• Serve as point of communication between company teams and external resources.
• Deepen partnerships with outside resources, including third-party vendors and researchers.

Other:

• Assist with and conduct routine and standardized experiments for relevant research projects.
• Petty cash management and disbursements.
• Perform other related duties and responsibilities as assigned/requested.

Minimum Qualifications

• Bachelor's degree or equivalent in education and experience required.
• Proficient record-keeping skills, organizational, and time management skills.
• Proactive, adaptive, strong work ethic.
• Experience in coordinating teams and clients.
• Proven success in a corporate or higher-education setting, working with all levels of management.
• Strong written, oral, and presentation skills.
• Willing to travel and attend domestic and international conferences.

Preferred Qualifications

• 2+ years in Basic or Clinical research.
• 3+ years of experience in project coordination.
• Works well independently and in a team setting with a broad spectrum of patients, scientists, medical personnel, and administrative departments.
• Professional certification such as PMP (Project Management Professional).
• Experience with Medical Records, RedCAP, IRB protocols.
• Prior experience in building grant proposals, budgets, applications for various sponsors (i.e. NIH, DOD, Foundations).

Equal Opportunity Employer / Disability / Veteran

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