• Job Type: Officer of Administration
• Bargaining Unit:
• Regular/Temporary: Regular
• End Date if Temporary:
• Hours Per Week: 35
• Standard Work Schedule:
• Building:
• Salary Range: $72,000 - $84,000

Position Summary

We 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. 

Responsibilities

• Under 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 sponsors
• Administer outcome measures and questionnaires, including slow vital capacity, handheld dynamometry, ECG, and cognitive testing
• Prepare and maintain detailed, organized, and complete source document binders in accordance with ALCOA principles, case report forms, progress notes, drug dispensation records, and regulatory forms
• Data 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 queries
• Record 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 lifecycle
• Assist with sample processing and storage, coordination of sample transport, and shipping specimens per IATA guidelines
• Maintain accurate and complete inventory of study supplies and orders additional supplies as needed
• Assist Principal Investigators and study teams in the collection of clinical data and samples for other research studies when needed
• Maintain regular contact with study team, SM, clinical staff, and sponsors to communicate day-to-day study status and patient safety updates in a timely manner
• Under SM’s supervision, manage study-specific regulatory tasks including IRB submissions, protocol/consent form modifications, contract and budget amendments, preparing for and overseeing site monitoring visits, and diligent maintenance of regulatory binders and submissions
• Provide guidance and training to junior members of the research team; assist in training and orienting new staff
• Perform additional related duties as assigned 

Minimum Qualifications

• Bachelor’s degree or equivalent in education, training, and experience, plus three years of related experience 

Preferred Qualifications

• Ability to perform day-to-day responsibilities independently and with minimal supervision
• Proficient knowledge of and ability to manage all phases of the clinical trial lifecycle in accordance with local, institutional, and federal regulations
• Ability to efficiently identify and triage complex regulatory scenarios and develop viable solutions to present to SM
• Proficiency in managing personnel issues and providing constructive feedback to study and management teams as well as junior staff
• Skilled at developing tracking systems to ensure timely execution of study tasks
• Strong interpersonal and communication skills; ability to interact with all levels of staff and external collaborators
• Confidence in handling multiple projects and competing priorities
• Experience with medical terminology, EPIC EMR, common electronic data capture systems, REDCap, and Excel

Equal Opportunity Employer / Disability / Veteran

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