Clinical Research Coordinator I

Columbia University Irving Medical Center; New York (NY); On-site; USD 66,000 - 68,000; Full time

Job summary

Columbia University Irving Medical Center (CUIMC) is seeking a Clinical Research Coordinator to support coordination of clinical research activities in the Department/Division of Surgery – Clinical Research Core. The role involves coordinating participant recruitment, screening, data collection, and adherence to study protocols, under supervision of the Clinical Research Manager and Director.

The CRC will liaise with clinicians, sponsors, and research staff, manage data entry including PHI, and

Qualifications

• Bachelor's degree or equivalent in education, training and experience.
• Strong customer-service orientation and ability to collaborate with multiple stakeholders.
• Ability to work semi-independently within a deadline-driven, multi-tasking environment.
• Commitment to diversity and equity.
• Willingness to learn new systems and programs.

Responsibilities

• Coordinate day-to-day study protocol tasks including recruitment, screening, enrollment and follow-up under supervision.
• Communicate effectively with study subjects, clinicians, sponsors and staff to support trials.
• Assist with coordinating research team meetings, sponsor visits, audits and stakeholder engagement.
• Ensure timely communication between Principal Investigator and compliance offices and sponsors.
• Perform data entry including PHI and administrative data.
• Maintain clinical research files and case report forms; assist with start-up/close-out documentation and AE reporting.
• Understand CAPA concepts and apply as needed.
• Coordinate financial transactions related to the study and assist participants with issues.
• Follow safety protocols and maintain inventory of research supplies.

Skills

Customer service

Stakeholder collaboration

Teamwork

Diversity commitment

Systems learning

Education

Bachelor's degree

Tools

Epic

REDCap

Qualtrics

iLab

OpenSpecimen

Job description

Grade 103

• Job Type: Officer of Administration
• Bargaining Unit:
• Regular/Temporary: Regular
• End Date if Temporary:
• Hours Per Week: 35
• Standard Work Schedule:
• Building:
• Salary Range: $66,300.00 - $68,000

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. Working in the Department/Division of Surgery – Clinical Research Core, under the direction of the Clinical Research Manager and Director, the CRC will support the coordination of clinical research activities according to clinical research studies or trials managed by the Department/Division. 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 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.
• Ensures timely notification and/or communication between the Principal Investigator and compliance offices and study sponsors.
• 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 preparation and completion of case report forms (CRFs), and completing any study start-up or close-out documentation, and adverse event (AE) reporting.
• Possess understanding and awareness of Corrective and Preventative Actions (CAPA).
• Coordinate financial transactions related to the study, including but not limited to compensation to study subjects for their participation and helping them to 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 inventory, requesting additional items as needed.
• 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 diversity and equity.
• 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 settings.
• 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

• Work requires manual dexterity for handling charts and using office equipment - specifically the use of a computer keyboard and calculator. Must be able to stoop and bend to retrieve files and supplies, and sit, stand or move around for extended periods of time.

Equal Opportunity Employer / Disability / Veteran

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