• Job Type: Officer of Administration
• Regular/Temporary: Regular
• Hours Per Week: 35.00
• Salary Range: Commensurate with experience

Position Summary

We are seeking a Clinical Research Coordinator I 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.

Responsibilities

The candidate will be responsible for preparation and conduct of research visits in the Department of Neurology at Columbia University. 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 (phase 1-3) involving children and adults with mitochondrial disorders.
• Preparation for and conduct of patient research procedures.
• Patient recruitment and eligibility assessment.
• Patient scheduling and travel arrangements.
• Obtain patient informed consent.
• Sample collection and processing
• Shipping and tracking of all samples.
• Coordination of staff involved in patient research visit.
• Database entry, query resolution and monitoring of progress.
• Prepare for and provide information at study monitor visits.
• Study drug orders, drug supply orders, drug accountability and patient compliance.
• Adverse event and severe adverse event documentation and resolution.
• Study deviation and violation documentation.
• Visit entry into financial database. 
• Monitor and reconcile sponsor payments for research visit.
• New IRB submissions and protocol updates.
• Assist with preparation of annual IRB renewals.
• Data collection and analysis for manuscript preparation.
• Assist with manuscript preparation.
  
  

Minimum Qualifications

Bachelor's Degree and at least two years related experience, at least one of which in a clinical trial setting, or an equivalent combination of education and experience.

Preferred Qualifications

Master's Degree preferred.    

Neuromuscular research experience preferred

Equal Opportunity Employer / Disability / Veteran

Columbia University is committed to the hiring of qualified local residents.