Clinical Research Coordinator I

Position Summary

We are seeking a Clinical Research Coordinator I (CRC I) for the ALS Center at Columbia University Medical Center. The CRC I will provide support in developing and executing ALS research initiatives. Reporting to the Center’s Principal Investigators (PIs) and Senior Managers (SMs), the CRC I 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

• Assists SMs with 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, Research Pharmacy, local laboratories, radiology)
• Manages study activities to ensure compliance with protocols and relevant federal, state, regulatory and institutional policies.
• Prepares and maintains detailed, organized, and complete source document binders in accordance with ALCOA principles, case report forms, progress notes, drug dispensation records, and regulatory forms.
• Assesses eligibility of potential subjects through review of medical records, screening interviews, and discussions with clinical staff and PIs. Oversees subject enrollment process to ensure that informed consent is properly obtained and documented.
• Records and reports adverse event data according to institutional and sponsor guidelines and confers with PIs and SMs regarding the reporting of events to oversight agencies. Maintains close contact with participants’ care team to obtain follow-up data throughout the adverse event lifecycle.
• Coordinates and conducts in-person and remote study visits by communicating closely with patients, hospital and research facility staff, research and clinical teams, and study sponsors.
• Administers outcome measures and questionnaires, including slow vital capacity, handheld dynamometry, ECG, and cognitive testing.
• Assists with sample processing and storage, coordination of sample transport, and shipping specimens per IATA guidelines. Maintains accurate and complete inventory of study supplies and orders additional supplies as needed.
• Oversees data entry and query resolution using Electronic Data Capture systems. Ensures data quality and integrity and performs and tracks internal and external data audits.
• 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.
• Assists SMs with regulatory tasks, including IRB submissions, protocol and consent form modifications, preparing for and attending site monitoring visits, and maintenance of site regulatory binders.
• Other duties as assigned.

Minimum Qualifications

• Bachelor’s degree or equivalent in education and experience

Preferred Qualifications

• 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
• Previous experience with Epic, iMedidata EDC, and/or Columbia’s RASCAL IRB module
• Phlebotomy certification