Clinical Research Coordinator II

Position Summary

Columbia University Irving Medical Center (CUIMC) provides global leadership in scientific research, health and medical education, and patient care. Home to approximately 4,472 students and over 3,000 part-time and full-time faculty members, the health sciences campus includes the four professional schools—the Vagelos College of Physicians and Surgeons, the College of Dental Medicine, the School of Nursing, and the Mailman School of Public Health.

Our staff is pivotal in facilitating and advancing these cutting-edge research endeavors.

Clinical Research Coordinators (CRCs) are key members of research teams at Columbia. They collaborate closely with Principal Investigators (PIs) managing and overseeing the various aspects of clinical trials and research. Key responsibilities and tasks include study coordination, data collection, regulatory compliance, and serving as a Research liaison. The ideal candidate would need strong communication, organizational, and interpersonal skills.

To be successful in this role, the Coordinator II should bring strong critical thinking, organizational skills and an ability to work collaboratively and independently in a deadline-driven environment.

Responsibilities

Clinical Trials Coordination

• Responsible for day-to-day aspects of study protocol tasks including participant recruitment, screening, enrollment and follow-up with study participants, specimen processing, and other key elements under some supervision.
• Effectively communicate, build, and maintain relationships with potential study subjects, participants, clinicians, and other health care providers, and research office staff to support the successful administration of clinical trials.
• Complete data entry activities with little supervision. Data entry may include Protected Health Information (PHI), clinical and billing or other administrative data. Maintain accurate and complete clinical research files which include administering questionnaires, completing case report forms (CRFs), completing any study start-up or close-out documentation.
• Prepare data reports and perform periodic auditing of data, certification, and reporting materials to ensure compliance with university, sponsor and federal policies.
• Coordinate fiscal transactions related to the study including compensation to study subjects for their participation and helping them troubleshoot any issues.
• Adhere to workplace and patient safety protocols, monitor the area to ensure compliance with ethical and safety standards for research and maintain and request additional supplies as needed.
• Uses tools and reporting mechanisms to track progress, identify trends, and ensure timely communication of issues and status.
• Represent Columbia University Irving Medical Center research as one of its frontline health research personnel and commit to using culturally appropriate communication methods. Performs all other duties as assigned.

Collaboration & Stakeholder Management

• Coordinate research team meetings, investigator check-ins, Sponsor visits, external audits and other stakeholder engagement activities.
• Demonstrates professionalism and accountability in interactions with clinical trials team and patients through clear, respectful, and timely communication and responsive follow-up.
• Supports training activities to ensure others understand clinical trial procedures.

Continuous Improvement

• Participates in and/or supports assigned team projects and initiatives and escalates issues or potential barriers.
• Keeps current on all organizational policies, goals, and initiatives.
• Successfully completes all required university, systems, and department trainings and assigned study certifications requirements.
• Performs all other duties as assigned.

Minimum Qualifications

• Requires a bachelor’s degree or equivalent in education and experience in a relevant clinical research field.
• Must possess critical thinking and analytical skills, customer service orientation, with the ability to interact and collaborate positively, constructively and effectively with multiple stakeholders.
• Capacity to work semi-independently and successfully within a team in a deadline driven, multi-tasking environment. Ability to handle multiple projects and apply judgment to prioritize projects and tasks.
• Strong oral and written communication skills.
• Strong commitment to fostering diversity and equity.
• Skilled with Microsoft Office, including strong Excel skills.
• Ability and willingness to learn new systems and programs.
• Phlebotomy Certified (or other forms of certification in lieu of phlebotomy such as certified medical assistant, nursing degree, medical degree) – current or obtained within 3 months.

Preferred Qualifications

• Bi-lingual (Spanish and English)
• 3 years experience in a clinical research setting.
• Familiarity with Columbia health and research systems.
• Education in a scientific, health-related or business administration program or experience with observational research or laboratory settings.
• Experience with electronic medical records and/or research data entry, including Epic, REDCap, Qualtrics, iLab, or Openspeciman.
• Understanding of clinical research systems and processes, Good Clinical Practice (GCP) guidelines, HIPAA, Columbia IRB and other institutional or federal regulatory and compliance activities.