The division of Movement Disorders in the Department of Neurology is seeking a Clinical Research Coordinator II. The Clinical Research Coordinator II will work closely with several principal investigators on clinical research studies for Parkinson's disease and other movement disorders, including experimental drug trials, genetic epidemiology, biomarkers, and brain and skin tissue banking. The Clinical Research Coordinator must be an experienced researcher with a strong clinical background, able to conduct and manage complex research projects, provide statistical expertise and support the development of scientific publications in the field of Parkinson 's disease.
1) Study Start-up:
Prepare IRB/GCO submission including informed consent and protocol summary
Prepare study-specific documents such as drug/device accountability log, screening log, patients ID log, signed CVs/Licenses, financial disclosure form, and Case Report Form.
Assist in preparing budget and contract if needed.
Participate in investigators meeting and study initiation visits.
2) Update and Maintain Regulatory Compliance:
Compile essential documents in accordance with Columbia University IRB Guidelines (signed protocol, investigator's brochure, FDA form 1572, CVs and licenses, Lab specifications, IRB member list, IRB approval letter, approved advertisement, correspondence).
Submit amendments/Renewals and other study materials to the IRB.
Update and maintain financial binder with letters of agreement, contacts, invoices, and receipts from sponsor.
3) Study Conduct and Recruitment:
Introducing clinical studies, performing screening histories, answering study participant questions, scheduling study visits, taking vital signs, assisting PI in performing electrocardiograms and phlebotomy, shipping out human specimens as per IATA protocol, data collection, recording adverse events, changes in concomitant medications, data-basing all relevant information, maintaining confidentiality and standards for good clinical practice according to CITI and IRB guidelines. The candidate will receive training and hold certifications meeting IATA, CITI and IRB requirements.
Obtain Training and perform Cognitive tests on the study participants.
Ensure the accuracy of quantitative evaluations and consistency of data collection.
Maintain source documents in accordance with Columbia University's SOPs.
Report Adverse Events and Serious Adverse Events in accordance with Columbia University's IRB Guidelines/SOPs.
Monitor study performance for subject enrollment goals and data acquisition in accordance with the protocols.
Serve as the primary site liaison and appropriately triages correspondence to relevant parties
4) Brain Tissue Banking:
Manage the activities of Columbia's Parkinson's disease brain bank, including educating patients and families about the need for brain tissue investigations, consenting prospective donors, establishing a pre-plan with families and coordinating the brain donation when death occurs.
This requires availability by phone 24/7 and excellent inter-personal skills.
In addition, the duties include maintaining electronic database of prospective donors and streamlining of the data obtained for presentation in academic conferences and scientific publications.
The position requires a bachelor's degree or equivalent in education and experience, plus four years of related experience.
Must have phlebotomy skills or be able to successfully complete phlebotomy skills training.
Master's degree in Public Health, Clinical Research or a related field and/or two years of clinical research experience and training.
Candidates must have excellent interpersonal, communication and organization skills as well as strong analytical and team management skills.
Hands-on experience with PC software for word processing, spreadsheets and/or statistical software.
Must have proven ability to work in a fast-paced research environment.
Must be capable of working independently as well as collaboratively.
Excellent time management skills
Strong writing and verbal communications skills
Knowledge in GCP, IRB and FDA regulations
Candidates seeking consideration must have previous experience with major, multifaceted projects with a broad range of participants and functionality.
Excellent information management, analytical, administrative, and organizational skills are needed.
Must be able to functions independently and use good judgment while being sensitive to the protocol guidelines and parameters.
The ideal candidate must possess a high degree of integrity towards the research goals set by the research team.
Equal Opportunity Employer / Disability / Veteran
Columbia University is committed to the hiring of qualified local residents.
Internal Number: 504498
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.