Clinical Research Coordinator III

Position Summary

The Clinical Research Coordinator (CRC) serves as the lead coordinator for NIH clinical research studies within the Department of Obstetrics and Gynecology, Division of Women’s Mental Health, supporting the successful implementation and management of clinical trials involving pregnant and postpartum populations and other women’s health research participants. This role is responsible for coordinating the day-to-day operational activities of assigned studies, including participant recruitment, screening, enrollment, study visits, specimen collection and processing, and participant follow-up. The CRC ensures that all research activities are conducted in accordance with study protocols, institutional policies, regulatory requirements, and Good Clinical Practice (GCP) guidelines. The coordinator may also mentor and oversee junior staff dedicated to these projects and contribute to training within the research team.

The CRC maintains accurate and comprehensive research documentation, including regulatory files, study logs, and participant records. Responsibilities include managing data entry across multiple research and clinical platforms, safeguarding Protected Health Information (PHI), and ensuring that research data are complete, accurate, and compliant with institutional and sponsor requirements. The coordinator may also assist in summarizing operational data and supporting investigators and research teams with data organization and reporting. Additional responsibilities include coordinating research visits, maintaining study supplies, facilitating participant compensation processes, and assisting with study start-up and close-out activities. The CRC may also contribute to the development of standard operating procedures (SOPs), best practices, and process improvements to strengthen research quality and operational efficiency.

The position requires strong organizational, communication, and problem-solving skills, as well as the ability to manage multiple priorities in a dynamic research environment. The CRC collaborates with investigators, sponsors, and institutional stakeholders during research meetings, monitoring visits, and audits.

Responsibilities

Clinical Trials Coordination

• Serving as the lead CRC, they are responsible for day-to-date aspects of study protocol tasks including participant recruitment, screening, enrollment and follow-up with study participants, specimen processing, and other key protocol elements.
• Effectively communicate, verbally and written, build and maintain relationships with potential study subjects, participants, clinicians, and other health care providers, and reach office staff to support the successful administration of clinical trials.
• Design recruitment and retention plans for a range of different study populations utilizing different modes of communication.
• Complete data entry activities, including Protected Health Information (PHI), clinical, billing, and other administrative data with minimal supervision and summarize and assist in analyzing operational data for the research team.
• Coordinate day-to-day aspects of study relayed procedures, documentation, and visit management.
• Maintain accurate and complete clinical research files which may include administering questionnaires, completing case report forms (CRFs), completing any study start-up or close-out documentation.
• 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 area to ensure compliance with ethical and safety standards for research, maintain the research supply inventory, requesting additional items as needed.
• Develops or contributes to the development of standard operating procedures, best practices and supporting tools required for maintaining subject confidentiality and privacy.
• Represent Columbia University Irving Medical Center research as one of its frontline health research personnel and commit to using culturally appropriate communication methods.
• Participate in on-call activities to cover research responsibilities off-hours, as needed. Contingent on division, may supervise
• Performs all other duties as assigned.

Collaboration & Stakeholder Management

• Collaborate 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 and provides guidance to team on proper documentation, compliance, and best practices for clinical trials.
• Designs materials, such as job aids to educate a wide range of audiences to support education and recruitment activities.

Continuous Improvement

• Participates in and/or supports assigned team projects and initiatives and escalates issues or potential barriers.
• Serves as a mentor and process expert for research staff and identifies potential vulnerabilities in research studies, including data, resource allocation, and compliance.
• Keeps current on all organizational policies, goals, and initiatives.
• Successfully completes all required university, systems, and department trainings.
• Performs all other duties as assigned.

Minimum Qualifications

• Bachelor's Degree and at least 3 years of relevant clinical research experience required, including in an academic/medical setting.
• Strong understanding of clinical research compliance regulations and protocols.
• Must possess strong 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 independently and successfully within a deadline driven, multi-tasking environment. Ability to handle multiple projects and apply judgment to prioritize projects and tasks.
• A demonstrated commitment to upholder the integrity and standards established for clinical research coordinators by professional organizations such as ACRP AND SOCRA.
• Strong commitment to fostering diversity and equity.
• Skilled with Microsoft Office, including strong Excel skills.
• Ability and willingness to learn new systems and programs.

Preferred Qualifications

• Bi-lingual (Spanish and English)
• CRC professional certification from ACRP, SOCRA, or equivalent agency.
• Familiarity with Columbia health and research systems.
• Education in a scientific, health related, or business administration program or experience with research or laboratory settings.
• Experience with electronic medical records and/or research data entry, including Epic, REDCap, Qualtrics, iLab, or OpenSpeciman.
• Research or laboratory experience preferred.
• 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
• Experience coordinating complex clinical trials from start to finish.
• Knowledge of clinical research systems and processes, Good Clinical Practice (GCP) guidelines, HIPAA, IRB, and other and compliance activities.

Job Type: Officer of Administration

Hours Per Week: 35

Salary Range: 66,300 - 76,500

*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.*

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.