• Job Type: Officer of Administration
• Regular/Temporary: Regular
• Hours Per Week: 35.00
• Salary Range: Commensurate with experience

Position Summary

We are seeking a clinical research coordinator (CRC) for the ALS Center at Columbia University Medical Center. The CRC will play an integral role in the coordination and conduct of clinical trials at the Center and will provide support in developing and executing ALS research initiatives. Alongside the PIs and Research Managers, the CRC will help coordinate the clinical and research efforts of the ALS Center. We are looking for someone who can establish good rapport with ALS patients and their families, as well as our clinical, research, and administrative teams. The ideal candidate is a team player who is independently motivated and able to self-direct.

Responsibilities

Coordinates initiation and start-up of clinical trials, including initial protocol submission, execution of contract and budget, and approvals for ancillary services (e.g. the Irving Clinical Research Center, CUMC Research Pharmacy, local laboratories, radiology).

Coordinates and carries out in-person and remote research study visits per protocol by communicating closely with patients, hospital/research facility staff, research team, sponsors and other pertinent groups.

Administers outcome measures and questionnaires (e.g. slow vital capacity, handheld dynamometry, ECG, cognitive testing).

Maintains and prepares detailed, organized, and complete source document binders.

Ensures timely Adverse Event/SAE documentation and reporting per IRB and sponsor guidelines.

Assists with sample processing and storage, coordination of sample transport, and shipping specimens per IATA guidelines.

Assists with data entry and query resolution using Electronic Data Capture (EDC) systems.

Ensures data quality and integrity, and compliance with all regulatory, institutional and departmental requirements.

Maintains regular contact with study team, hospital staff, and sponsors to ensure day-to-day study status and patient safety updates are communicated in a timely manner.

Completes regulatory tasks including IRB submissions, protocol/consent form modifications, preparing for and attending site monitoring visits, and maintenance of regulatory binders.

Performs additional related duties as assigned.

Minimum Qualifications

Bachelor’s degree or equivalent in education, training, and experience, plus 2 years of patient-facing clinical research experience.

Ability to communicate clearly and effectively with patients, coworkers, and medical staff.

Close attention to detail and strong interpersonal communication skills.

Ability to balance self-sufficiency with collaborative teamwork.

Proficient in handling multiple projects and competing priorities.

Experience with medical terminology, Electronic Medical Records systems, EDCs, and Excel.

Preferred Qualifications

Previous experience with Epic EMR, iMedidata EDC, and/or Columbia’s RASCAL IRB module.

Phlebotomy certification.

To be considered for this position, please complete the master application in its entirety. Applications submitted without a cover letter or resume will not be considered.

Equal Opportunity Employer / Disability / Veteran

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