Clinical Research Coordinator I

Clinical Research Coordinator I

Position Summary

Clinical Research Coordinators (CRCs) are key members of research teams at Columbia University Irving Medical Center (CUIMC). They collaborate closely with Principal Investigators (PIs), managing and overseeing the various aspects of clinical trials and research. Key responsibilities include study coordination, data collection, regulatory compliance, and serving as a research liaison. The ideal candidate has strong communication, organizational, and interpersonal skills; a background in research or health administration is a plus, but not a requirement.

This Clinical Research Coordinator I position will support the division of movement disorders clinical research core within the department of Neurology. The candidate will report to the senior clinical research manager and will assist in executing a broad portfolio of movement disorders research initiatives, including gene therapy, stem cell therapy, biomarker, and observational studies spanning Parkinson’s disease, essential tremor, multiple system atrophy, spinocerebellar ataxia, and other movement disorders and neurodegenerative conditions.

Responsibilities

The candidate will be responsible for the following, under the level of supervision appropriate to a Clinical Research Coordinator I:

Clinical Trials Coordination:

• 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.
• Maintain accurate and complete clinical research files, which may include administering questionnaires and maintenance of case report forms (CRFs).
• 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.
• Possess understanding and awareness of Corrective and Preventative Actions (CAPA).
• Coordinate financial transactions related to the study including compensation to study subjects for their participation and helping them 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.
• Assists in submission of closeout documents to applicable agencies and sponsoring parties in accordance with policies and procedures.

Collaboration & Stakeholder Management:

• Ensure timely notification and/or communication between the Principal Investigator and compliance offices and study sponsors.

Continuous Improvement:

• Participates in and/or supports assigned team projects and initiatives and escalates issues or potential barriers.
• Keeps current on all organizational policies, goals, and initiatives.
• Successfully completes all required university, systems, and department trainings.

Movement Disorders Division Focus:

• Support recruitment and consenting activities for pharmaceutical company-sponsored and federally funded studies related to Parkinson’s disease, essential tremor, multiple system atrophy, spinocerebellar ataxia, and other movement disorders and neurodegenerative conditions.

• Assist with coordination of gene and cell therapy trials, including Single Patient IND submissions and Expanded Access Program requests, in collaboration with academic and industry partners.

• Travel to different research and clinical locations as needed, as well as to investigator meetings and conferences.

• 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.

• Working knowledge of Microsoft Office, including strong Excel skills.

• 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 a laboratory setting.

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

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

• Phlebotomy Certified (or other forms of certification in lieu of phlebotomy such as certified medical assistant, nursing degree, medical degree).

• Highly motivated and interested in movement disorders research (Parkinson’s disease, essential tremor, multiple system atrophy, spinocerebellar ataxia, and other movement disorders and neurodegenerative conditions).

• Other Requirements

• The position located in both Manhattan and Westchester locations.

• Equal Opportunity Employer / Disability / Veteran

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