Clinical Rsch Coordinator I

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 sciencescampus 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 variousaspects 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.A background in research or health administration is a plus, but not a requirement.

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 protocol

elements under direct supervision.

Effectively communicate and maintain relationships with potential study subjects, participants,

clinicians, other health care providers, sponsors, and research office staff to support the successful

administration of clinical trials.

Assist with the coordination of research team meetings, investigator check-ins, sponsor visits, external

audits, and other stakeholder engagement activities. Supports research team members on various

clinical trials or study related tasks.

Maintain accurate and complete clinical research files, which may include administering

questionnaires and maintenance of case report forms (CRFs)

• Complete data entry activities with supervision and support as needed. Data entry may include Protected Health Information (PHI), clinical and billing or other administrative data.
• Possess understanding and awareness of Corrective and Preventative Actions (CAPA).
• Coordinate financial 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 and ensure compliance with ethical and safety standards for research, and maintain research supply inventor, requesting additional items as needed.
• Assists in submission of closeout documents to applicable agencies and sponsoring parties in accordance with policies and procedures.
• Performs all other duties as assigned.

Collaboration & Stakeholder Management

Ensure timely notification and / or communication between the Principal Investigator and compliance offices and study sponsors.

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.

Minimum Qualifications

• Bachelor's Degree or equivalent in education, training, and experience
• Must possess a 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 teams in a deadline driven, multitasking environment.
• Strong commitment to fostering diversity and equity.
• Working knowledge of Microsoft Office, including strong Excel skills.
• Ability and willingness to learn new systems and programs.

Preferred Qualifications

• Bi-lingual (Spanish and English).
• At least 2 years of experience in a relevant clinical research field.
• Familiarity with Columbia health and research systems.
• Education in a scientific, health-related, or business administration program or experience with observational research or in laboratory setting.
• Experience with electronic medical records and / or research data entry, including REDCap and Qualtrics, iLab, or OpenSpeciman.
• Knowledge of clinical research systems and processes, Good Clinical Practice (GCP) guidelines, HIPAA, IRB and other regulatory and compliance activities.
• Phlebotomy certification

The Department of Obstetrics and Gynecology is dedicated to the goal of building a multicultural faculty and staff committed to teaching, working and serving in a diverse community, and strongly encourages applications from candidates of traditionally underrepresented backgrounds.

We are continuously seeking to recruit individuals who will enhance the diversity of our workplace and the effectiveness of our organization.