Job Description

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 SummaryWe are seeking a Clinical Research Coordinator II (CRC II) for the Eleanor & Lou Gehrig ALS Center at Columbia University Medical Center. The CRC II 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 Center’s Principal Investigators (PIs) and Senior Managers (SMs), the CRC II will help coordinate the clinical research efforts of the ALS Center. We are looking for someone who can establish 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. ResponsibilitiesUnder SM’s supervision, coordinate the 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)Coordinate and conduct in-person and remote study visits by communicating closely with patients, hospital and research facility staff, research and clinical teams, and study sponsorsAdminister outcome measures and questionnaires, including slow vital capacity, handheld dynamometry, ECG, and cognitive testingPrepare and maintain detailed, organized, and complete source document binders in accordance with ALCOA principles, case report forms, progress notes, drug dispensation records, and regulatory formsData reporting and management, collection of source documents, use and development of case report forms, adverse events reporting, filing and archiving study records, and resolution of data queriesRecord and report adverse event data according to institutional and sponsor guidelines; confer with PIs and SMs regarding the reporting of events to oversight agencies; maintain close contact with participants’ care team to obtain follow-up data throughout the adverse event lifecycleAssist with sample processing and storage, coordination of sample transport, and shipping specimens per IATA guidelines