Clinical Research Coordinator - Endocrinology

• Job Type: Officer of Administration
• Regular/Temporary: Regular
• Hours Per Week: 35
• Salary Range: $66,300 - $66,300

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.

Position Summary

Columbia University Irving Medical Center (CUIMC) provides global leadership in scientific research, health and medical education, and patient care. Within the Department of Medicine, Division of Endocrinology, the Clinical Research Coordinator (CRC) will work under the direction of the Principal Investigator and research leadership to support the coordination and implementation of clinical research studies and trials conducted within the Division.

The CRC will be responsible for coordinating patient participation activities, including screening, recruitment, enrollment, assessment, and follow-up of study participants; collecting and maintaining study data; ensuring adherence to study protocols and regulatory requirements; and collaborating with investigators, sponsors, and research staff to facilitate the successful conduct of clinical research. The CRC will serve as a key member of the research team and contribute to the efficient execution of multiple clinical studies.

Responsibilities

• Coordinate day-to-day study activities, including participant recruitment, screening, enrollment, retention, and follow-up, specimen collection and processing, and other protocol-specific procedures under appropriate supervision.
• Establish and maintain effective working relationships with study participants, clinicians, research staff, sponsors, and institutional stakeholders to support the successful conduct of clinical research studies.
• Assist in coordinating research team meetings, investigator meetings, sponsor visits, monitoring visits, audits, and other research-related activities.
• Support investigators and research personnel with study implementation and ongoing protocol requirements.
• Ensure timely communication between Principal Investigators, study sponsors, Institutional Review Boards (IRBs), compliance offices, and other regulatory entities, as appropriate.
• Adhere to workplace safety, patient safety, and research compliance standards; monitor research activities to ensure adherence to ethical, regulatory, and institutional requirements.
• Maintain research supply inventories and coordinate procurement of study-related materials as needed.
• Demonstrate an understanding of Corrective and Preventive Action (CAPA) processes and support the implementation of corrective actions when required.
• Coordinate study-related financial transactions, including participant compensation, reimbursement processes, and troubleshooting payment-related issues.
• Perform accurate data entry and data management activities, including entry of Protected Health Information (PHI), clinical data, billing information, and other study-related data.
• Maintain complete and accurate research records, including study regulatory files, case report forms (CRFs), study logs, source documentation, questionnaires, adverse event (AE) reports, and study start-up and close-out documentation.
• Assist in monitoring study progress and ensuring protocol compliance, participant safety, and data integrity.
• Represent Columbia University Irving Medical Center as a frontline member of the research enterprise and utilize culturally sensitive and inclusive communication practices when interacting with research participants and stakeholders.
• Perform additional related duties and responsibilities as assigned.

Minimum Qualifications

• Bachelor's degree or an equivalent combination of education, training, and experience.
• Strong customer service orientation with the ability to interact effectively and professionally with research participants, investigators, sponsors, and institutional partners.
• Ability to work independently while contributing effectively within a collaborative team environment.
• Strong organizational skills with the ability to manage multiple priorities and meet deadlines in a fast-paced research setting.
• Commitment to fostering inclusion, engagement, and respectful interactions with diverse populations.
• Proficiency in Microsoft Office applications, including strong working knowledge of Excel.
• Ability and willingness to learn new systems, software applications, and research processes.
• Excellent written, verbal, and interpersonal communication skills.

Preferred Qualifications

• Bi-lingual (English and Spanish).
• At least two years of experience in a relevant research field.
• Familiarity with Columbia University health and research systems.
• Educational background in a scientific, health-related, public health, or business administration discipline.
• Experience with observational research, clinical research, laboratory-based research, or human subjects research.
• Experience using electronic medical records and research data systems, including Epic, REDCap, Qualtrics, iLab, and OpenSpecimen.
• Knowledge of clinical research regulations and best practices, including Good Clinical Practice (GCP), HIPAA, human subjects protections, Columbia IRB processes, and federal regulatory requirements.

Other Requirements

• Medical clearance and participation in the medical surveillance program
  
  • Contact with patients and/or human research subjects
• Successful completion of applicable compliance and systems training requirements

Equal Opportunity Employer / Disability / Veteran

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