We are seeking a Clinical Research Coordinator to join our expanding clinical research team at the Eleanor and Lou Gehrig ALS Center. The CRC will assist Principal Investigators and Research Managers in running multiple investigator-initiated and industry-sponsored research programs.
Coordinates and executes in-person research study visits per protocol by communicating closely with patients, hospital/research facility staff, research team, sponsors and other pertinent groups.
Maintains and prepares detailed, organized study source document binders.
Assists in sample processing and storage, coordination of sample transport, and shipping specimens per IATA guidelines.
Assists in timely Adverse Event/SAE documentation and reporting per safety guidelines.
Assists with data entry and query resolution using multiple Electronic Data Capture systems.
Ensures data quality, integrity and compliance with all regulatory, institutional and departmental requirements.
Establishes and maintains regular communication with study team, hospital staff, and study sponsors to ensure day-to-day study status and patient safety updates are communicated.
Assist with regulatory management, IRB submissions, protocol/consent form modifications, maintenance of regulatory binder.
Performs additional related duties as assigned.
Bachelor's degree or equivalent in education and experience required.
Minimum 2 years related experience required.
Experience with Electronic Medical Records Systems (EMR), Electronic Database Capture (EDC) and Excel.
Contact with patients and/or human research subjects.
Will be required to undergo institutional Good Clinical Practices (GCP) and HIPAA certification training.
Successful completion of application compliance and systems training requirements.
Ability to communicate effectively with patients, physicians, nurses, and hospital staff.
Close attention to details and strong interpersonal communication skills.
Ability to balance self-sufficiency with collaborative teamwork.
Proficient in juggling multiple projects and priorities.
Equal Opportunity Employer / Disability / Veteran
Columbia University is committed to the hiring of qualified local residents.
Internal Number: 508693
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.