Clinical Research Coordinator I

Columbia University Irving Medical Center is seeking a Clinical Research Coordinator I to support day-to-day operations for ongoing research projects in the Neurologic Intensive Care Unit, including coordinating and administering clinical trials. The role also offers opportunities to participate in mentored independent research projects and attend national conferences.

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

Preferred

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 setting

Experience with electronic medical records and/or research data entry, including REDCap and Qualtrics, iLab, or OpenSpeciman

Knowledge of clinical research systems and processes, Good Clinical Practice (GCP) guidelines, HIPAA, IRB and other regulatory and compliance activities

At least 2 years of experience in a relevant clinical research field.

Spanish-English Bilingualism

Clinical Research Experience

Columbia Health Systems

Columbia Research Systems

Scientific Education

Health-Related Education

Business Administration Education

Observational Research

Laboratory Experience

Electronic Medical Records

Research Data Entry

REDCap

Qualtrics

iLab

OpenSpecimen

Clinical Research Systems

Clinical Research Processes

Clinical Practice

HIPAA

IRB

Regulatory Compliance

Research Compliance

Benefits

Opportunity to work on mentored independent research projects and attend national conferences.

Company

Academic medical center providing patient care, research, and education.

New York, New York, USA

https://www.cuimc.columbia.edu/

Founded in 1767

10001+ employees

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

Working knowledge of Microsoft Office, including strong Excel skills

Ability and willingness to learn new systems and programs

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 setting

Experience with electronic medical records and/or research data entry, including REDCap and Qualtrics, iLab, or OpenSpeciman

Knowledge of clinical research systems and processes, Good Clinical Practice (GCP) guidelines, HIPAA, IRB and other regulatory and compliance activities

Required skills

Microsoft Excel, Microsoft Office, Clinical Research, Electronic Medical Records, REDCap, Qualtrics, iLab, OpenSpeciman, Clinical Practice (GCP), HIPAA, Institutional Review Board (IRB), Observational Research

Preferred skills

Bi-lingual (Spanish and English), Familiarity with Columbia health and research systems

Experience

2+ years