Clinical Research Coord I

• Job Type: Officer of Administration
• Regular/Temporary: Regular
• Hours Per Week: 35
• Salary Range: $66,300 - $70,000

Position Summary

Columbia University Irving Medical Center (CUIMC) provides global leadership in scientific research, health and medical education, and patient care. Working in the Department of Medicine under the direction of the Principal Investigator, the CRC will support coordination of clinical research activities for clinical research studies or trials managed by the Center of Quality Life and Aging. In general, the CRC will be responsible for the coordination of patient participation (including screening, recruitment, assessment, and follow-up of study participants), collection and maintenance of study data, ensuring adherence to study activities as described in the protocol, and working with other members of the research team to coordinate all other aspects related to the conduct of the clinical trial or study.

Responsibilities

• 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 coordinating research team meetings, investigator check-ins, Sponsor visits, external audits, and other stakeholder engagement activities.
• Support research team members on various clinical trials or study-related tasks.
• Assist with developing and maintaining study manuals of operations, study questionnaires, participant-facing materials, and other study documentation. 
• Participate in community-based recruitment and data collection activities as required by study protocols, including occasional work outside standard business hours. 
• Provide translation of study documents and materials from English to Spanish, as required by study needs. 

Compliance & Quality

• Ensure timely notification and/or communication between the Principal Investigator and compliance offices and study sponsors.
• Possess understanding and awareness of Corrective and Preventative Actions (CAPA).
• Assist with preparing and submitting regulatory documents, including IRB renewals, modifications, annual submissions, correspondence, and audit-related documentation. 
• Support internal and external audits through maintenance of complete and accurate study documentation. 

Financial & Administrative

• Coordinate participant compensation and payment issue resolution. 
• Assist with financial tracking of study-related expenses, invoice review and confirmation, and maintenance of supporting documentation. 
• Maintain inventory of research, laboratory, and office supplies and coordinate procurement activities. 

Data & Reporting

• 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.
• Maintain accurate and complete clinical research files, which may include administering questionnaires, assisting with preparation and completion of case report forms (CRFs), and completing any study start-up or close-out documentation and adverse event (AE) reporting.
• Assist with preparing database query reports and resolving data discrepancies. 
• Assist with preparation of abstracts, presentations, and submissions for scientific conferences. 

Other

• Represent Columbia University Irving Medical Center research as one of its frontline health research personnel and commit to using culturally appropriate communication methods.
• Perform other related duties and responsibilities as assigned/requested.

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, multi-tasking environment.
• Strong commitment to fostering inclusion and engagement.
• Working knowledge of Microsoft Office, including strong Excel skills.
• Ability and willingness to learn new systems and programs.

Preferred Qualifications

• Bilingual (Spanish and English)
• At least 2 years of experience in a relevant clinical research field
• Familiarity with Columbia Health and research systems
• Ability to perform phlebotomy. 
• Education in a scientific, health-related, or business administration program or experience with observational research or in laboratory settings
• Experience supporting scientific abstracts, publications, presentations, or conference submissions. 
• Experience with electronic medical records and/or research data entry, including Epic, REDCap, Qualtrics, iLab, or OpenSpecimen.
• Knowledge of clinical research systems and processes, Good Clinical Practice (GCP) guidelines, HIPAA, Columbia IRB, and other institutional or federal regulatory and compliance activities.

Other Requirements

• Medical clearance and participation in the medical surveillance program.
  • Contact with patients and/or human research participants.
  • Potential bloodborne pathogen exposure.
• 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.