We are seeking a Clinical Research Coordinator II for the Neuromuscular Clinical Research Center at Columbia University Medical Center. The candidate will report to the Principal Investigator (PI) of the studies under consideration.
The candidate will be responsible for providing direction and supervision of operations and for the management of all aspects of clinical trials. Additional responsibilities include maintaining compliance with existing policies and procedures at Columbia University, the IRB, FDA, NIH, and NYPH that relate to clinical research conducted at the Neuromuscular Center.
In addition, the candidate will be responsible for the following:
Ensure the successful implementation and management of multi-disciplinary clinical trials involving children and adults with mitochondrial disorders.
Design, assemble, and train the clinical trial's team for prospective clinical trials.
Develop and evaluate patient information, informed consent forms and patient recruitment.
Study Start Up: assess trial feasibility and set-up, protocol and budget evaluations for operational and fiscal feasibility; protocol submission to the IRB, the Clinical Trial's Office (CTO), and site initiation readiness.
Manage all aspects of the clinical trial cycle, across all phases of the drug development process (Phase I-III); this includes but it is not limited to: recruitment and follow up of subjects including screening/assessment of eligibility, conducting Informed Consent, visit coordination, conduct all study procedures, database study results, sample collection and processing, shipping and tracking of all samples, and study close out.
Fiscal supervision of all trials under applicant's purview -- manage all studies' invoices (across various hospital and research units (CRR, pharmacy, etc, to ensure accuracy and protocol compliance. Other invoicing activities include the management and upkeep of the CTO's invoicing system, Study Manager.
Actively participate in the development of SOPs and case report forms (CRFs) for the various studies for Sponsor and PI-initiated studies.
Ensure that all involved in the clinical trial, from subjects to evaluators to care providers adhere to the protocol and GCP guidelines; always putting the safety of the patient first.
Conduct all study related activities including: patient recruitment, study procedures, sample preparation and shipment, queries, completion of CRF's, IRB updates, patient visit arrangement and data entry.
Manage the ongoing communication of all clinical trials under your supervision including communication with sponsors, monitors, patients, safety committees, and medical monitors, among others.
Document and report protocol deviations and exemptions as well as development and implementation of corrective action plans (CAPs) for review by the Principal Investigator and IRB as needed.
Prepare and continually report serious adverse events (SAEs) to Sponsor(s) and Safety Committee in a timely manner; collect and process all medical records and extrapolate pertinent information for safety reporting and data management.
Work closely with data management to prepare data for interim analyses for future drug efficacy assessment/review.
Close-out of the clinical trial, contributing to manuscripts, audit preparation, trial completion, and communication with authorities.
Other responsibilities include assisting with the final study report and completing financial obligations.
Bachelor's Degree and at least four year related experience, at least two of which in a clinical trials setting, or an equivalent combination of education and experience.
Master's Degree preferred.
Neuromuscular research experience preferred.
Equal Opportunity Employer / Disability / Veteran
Columbia University is committed to the hiring of qualified local residents.
Internal Number: 512939
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.