• Job Type: Support Staff - Union
• Bargaining Unit: SSA
• Regular/Temporary: Regular
• End Date if Temporary:
• Hours Per Week: 35.00
• Standard Work Schedule: Monday-Friday 9am-5pm
• Building: 710 W. 168th Street, New York, NY
• Salary Range: $58,102.42 - $58,102.42

Position Summary

We are seeking a Research Assistant to join our expanding clinical research team at the Eleanor and Lou Gehrig ALS Center. The RA will assist Principal Investigators and Research Managers in running multiple investigator-initiated and industry-sponsored research programs.   

Responsibilities

• 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, management of sample inventory, coordination of sample transport, and shipping specimens per IATA 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
• Assists with regulatory management, IRB submissions, protocol/consent form modifications, maintenance of regulatory binder
• Assists in timely Adverse Event/SAE documentation and reporting per safety guidelines
• Performs additional related duties as assigned

Minimum Qualifications

• Requires a bachelor's degree and at least 1.5 years of related experience or equivalent in education, training and experience. 
• 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 

Preferred Qualifications

• 1 year of patient-facing, clinical research experience
• Experience with Electronic Medical Records Systems (EMR), Electronic Database Capture (EDC) and Excel

Other Requirements

• 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

Equal Opportunity Employer / Disability / Veteran

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