• Job Type: Support Staff - Union
• Bargaining Unit: SSA
• Regular/Temporary: Regular
• End Date if Temporary:
• Hours Per Week: 35.00
• Standard Work Schedule:
• Building:
• Salary Range: 59,845.49 - 59,845.49
  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
  We are seeking a Research Assistant to join our expanding clinical research team at the Eleanor and Lou Gehrig ALS Center. The Research Assistant 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

• 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 assigne