The Institute for Genomic Medicine seeks to hire a skilled individual who enjoys working with people and possess excellent interpersonal and communication skills to work as a Senior Clinical Research Coordinator for a multi-year research program. The activities performed by the Senior Clinical Research Coordinator are part of a national initiative which will contribute significantly to the development of a research cohort seeking to engage a million or more Americans. Research participants in this cohort will be asked to volunteer their health data over many years to improve health outcomes, fuel the development of new treatments for disease, and catalyze a new era of databased and more precise preventative care and medical treatment. The overall objective of this study is to obtain informed consent to participate in the All of Us Research Program, gather physical measurements, blood pressure, collect biospecimens (i.e., blood, saliva), and administer study questionnaires to be used for future research purposes. New patients will be approached in the outpatient clinics and inpatient setting.
The Senior Clinical Research Coordinator, reporting to the All of Us Clinical Research Enrollment Manager, and working in close collaboration with the Operations Manager, will demonstrate competence in clinical research skills, problem-solving, priority setting and serve as a resource for others for all aspects of conducting a clinical trial for a complex and multi-center trial. Senior Clinical Research Coordinators will be responsible for overseeing several members of the research staff including clinical research site specialist(s), clinical research coordinator(s), and research outreach coordinator(s). In addition, they will be responsible for 3-5 enrollment sites at a given time and will be responsible for developing clinical workflows in coordination with the practice manager and the Clinical Research Enrollment Manager.
In addition, the Senior Clinical Research Coordinator will explain the All of Us Research Program to participants and facilitate digital enrollment in the program if the participant is eligible. The coordinators will review and follow research protocols and determination data management requirement for each patient enrolled; interacts with the regulatory office to maintain regulatory documents and administrative files for each protocol. Research coordination includes working with a research nurse, treating physicians, and clinical team to facilitate confirm that each patient meets eligibility criteria specified for protocols and enrollment into the study. Both patient and regulatory research records will be maintained. This involves working in conjunction with the study team to gather all required data and relevant clinical information. The incumbent will support the day-to-day recruitment of subjects for this study, which include but are not limited to: active interaction with potential participants in high-volume patient waiting rooms, participating in weekly meetings with enrollment team, data collection, maintaining screening and recruitment logs, obtaining in-person informed consent, collecting biospecimens (i.e., blood, saliva, urine), assessing and reporting barriers to recruitment. S/he will perform other related duties as assigned.
The Senior Clinical Research Coordinator will work independently as well as part of a team. Coordinators will be required to relate to diverse populations. S/he will connect with participants to build report for long-term commitment to and engagement with the All of Us Research Program. Communications skills include excellent written communication skills, compassion, discretion, and follow-through
Supervise and manage members of the clinical research team for the All of Us Research Program. Serve as a resource for others for all aspects of conducting a clinical trial for a complex and multi-center trial.
Develop and implement associated projects related to study under the guidance of the All of Us Research Program leadership.
Collaborate effectively with others to ensure proper progress & completion of study.
Assist other members of the clinical research team by educating, providing resources, and consulting on protocol or projects.
Develop superb relationships with enrollment site(s) to facilitate efficient and effective workflows within a clinical environment.
Coordinate staff needs based on clinic schedules
Work with other divisions as needed to ensure proper handling, processing, storage and tracking of specimens per study requirements.
Coordinate complex regulatory activities and periodic internal self-audit of records.
May lead staff in regulatory activities.
Coordinate and participate in monitor visits, audits and quality reviews (internal and external) in a professional manner.
Oversee study staff for recruitment/enrollment at specific enrollment site(s).
Proactively take initiative to ensure recruitment stays on track with the project timeline.
Engage study staff to assist in identifying and enrolling participants.
Proactively identify and monitor barriers to recruitment and problem-solve or innovate to overcome them.
Create and maintain a detailed tracking system for participants.
Track progress at regular intervals and report out to clinical and study management.
Requires a Bachelor's degree or equivalent plus two years of related experience
Phlebotomy skills preferred.
Bilingual in English/Spanish preferred fluency in other languages will be considered.
Demonstrated experience in clinical research recruitment required.
The position requires excellent organizational, communication, and interpersonal skills, attention to detail and the ability to work independently
Proficiency in Microsoft Office required
Equal Opportunity Employer / Disability / Veteran
Columbia University is committed to the hiring of qualified local residents.
Internal Number: 499769
About Columbia University
Columbia University is one of the world's most important centers of research and at the same time a distinctive and distinguished learning environment for undergraduates and graduate students in many scholarly and professional fields. The University recognizes the importance of its location in New York City and seeks to link its research and teaching to the vast resources of a great metropolis. It seeks to attract a diverse and international faculty and student body, to support research and teaching on global issues, and to create academic relationships with many countries and regions. It expects all areas of the university to advance knowledge and learning at the highest level and to convey the products of its efforts to the world.