The Senior Research Coordinator (SRC) for the Transplant Clinical Research Center (TCRC) will report directly to the Associate Director. The main role of the SRC will be to operate & maintain the day-to-day operational duties of their assigned clinical trials and clinical research study database. The SRC will be responsible for overseeing conduct of the TCRC portfolio of studies. Job responsibilities include, but are not limited to the following:
Develop plans for protocol implementation, identify necessary resources and request as appropriate. This includes instruments, equipment and staff.
Determine recruitment objectives and develop systems to monitor and track achievement.
Contribute to the grant application process.
Carry out required staff training and provide the direct supervision for research assistants and other staff.
Assist in supervision and provide assistance to the clinical research coordinators, technician(s), research associates and all other research staff members that are involved in the research trials and studies.
Provide on-boarding training and guidance for all new research staff .
Assist the Associate Director in the preparation of study budgets, research related cost estimate forms, and initiation of all new adult research studies and trials.
Be the "first line" of contact for research coordinators.
In collaboration with the other research managers, develop all day-to-day plan and procedures for data collection as well as data confidentiality and data security for research coordinators and techs in the TCRC.
Be responsible for mechanisms and details of protocol adherence and for providing administrative back-up to the Director of the TCRC.
Assist in the preparation and submission of annual reports and regulatory information to funding and regulatory agencies.
Assist the regulatory team with the preparation of IRB applications.
Prepare and submit regulatory documentation to the regulatory bodies as relevant.
Assist investigators with validation and editing of collected data.
Analyze study data and assist in preparing manuscript.
Regularly collaborate with PIs, clinical staff, and other research staff.
Develop and maintain procedures for organizing work and staff.
Attend investigator meetings as needed.
Maintain study documents and files, such as regulatory binders and CVs etc.
Complete GCP, HIPAA and applicable regulatory training.
Complete certification requirements for assigned protocols.
Screen designated schedules or patient lists for eligible subjects.
Approach and verify eligibility subjects.
Schedule of research visits.
Collect research specimens.
Process, transport, and ship biological specimens as assigned and following of instructions as delineated in the protocol or manual of operations.
Complete study documents and files; some examples might include case report forms, worksheets and medical record notes.
Maintain confidentiality of documents and files such as HIPAA.
Assist in other research related activities and projects as needed.
Maintain detailed study files & complete paper case report forms & uploading of electronic case report forms/data within 48 hours of collection.
Obtain fully informed consent of all eligible trial & study patients in accordance to IRB, local & federal statutes
Clearly and effectively communicate with potential study subjects, clinicians, other health care providers, ancillary staff, sponsors, and research office staff.
Collect, process, and assist in the compilation and verification of research data, samples, and/or specimens (following strict protocol and detailed instructions); data is collected through medical chart review, recording of physiologic, imaging data, structured interviews with patients and family members, and conducting all follow up visits in strict accordance with protocol specifications
Work with regulatory coordinators in submitting new protocols, amendment, renewals, and other regulatory submissions to IRB, sponsor, FDA, and other regulatory bodies.
Instruct, oversee, and ensure appropriate coordination of day-to-day aspects of study related procedures for research coordinators and techs, including, but not limited to: scheduling study subject visits and procedures, data entry, preparation for research visits, research visit documentation, maintenance of regulatory binders and study files, creation and/or maintenance of source documentation, and preparation for monitoring visits, site initiation/closeout visits and audits as needed.
Instruct, oversee & ensure appropriate coordination of research staff handling & processing of human bio-specimens such as blood, saliva, and stool.
Working with research managers in developing and overseeing the "on call" system for research staff to cover all active clinical studies in TCRC.
Review research subject billing for compliance.
Collaborate with the Clinical Trials Office and finance teams to review and ensure appropriate invoicing for studies.
Requires bachelor's degree or equivalent in education and experience.
Minimum related experience:
Three years of related experience.
Experience with statistical analysis programs (ie. SAS, SPSS, STATA) is preferred.
Working knowledge of MS Office, specifically Word and Excel is required.
Experience with statistical analysis programs (ie. SAS, SPSS, STATA) .
Intermediate MS Office skills.
Equal Opportunity Employer / Disability / Veteran
Columbia University is committed to the hiring of qualified local residents.
Internal Number: 510371
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