Clinical Research Coordinator - Endocrinology

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

Position Summary

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.