Clinical Research Coord II
Company: Columbia University
Location: New York
Posted on: June 12, 2021
- Requisition no: 512939
- Work type: Full Time
- Location: Medical Center
- School/Department: Neurology
- Grade: Grade 105
- Categories: Health/Clinical
- Job Type: Officer of Administration
- Regular/Temporary: Regular
- Hours Per Week: 35
- Salary Range: Commensurate with experience
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
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
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
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
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
Applications open: Feb 18 2021 Eastern Standard Time
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Keywords: Columbia University, New York , Clinical Research Coord II, Other , New York, New York
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