Staff Associate

Job Description:

The certified Clinical Research Associate (CRA) will monitor clinical trials from study startup through the end of the trial, in accordance with FDA Regulations, ICH, GCP, SOPs and study protocols. In addition, the CRA will provide expertise & project support in order to accomplish one or more clinical trials, and will build relationships with clinical coordinators and effectively communicate ideas and results with the data coordinating center, clinical sites, and NIH.
Responsibilities include but are not limited to: Coordinate site initiation visits, conduct monitoring visits and close out visits. Collect, review, track and maintain regulatory documents from each site (including review of ICF/HIPAA templates) as part of pre-study activities Track relevant study data and review CRFs and/or data listings. Track Serious Adverse Events and prepare internal SAE Capsule summaries as needed.

Participate in the close out the study. Write/prepare reports related to monitoring of the study sites. Assure timely and appropriate involvement of critical staff at the clinical sites or the data coordinating center. Assure adherence to timelines. Participate in development of a data management plan.

Required Experience:

The ideal candidate will possess a Bachelor’s degree in nursing or equivalent in education or experience, with at least 4 years of monitoring experience either in a Pharmaceutical, Biotech or CRA environment and knowledge of FDA regulations. Must be a certified CRA. The position requires strong oral and written communication skills and excellent organizational skills, as well as the ability to work independently as well as with a Project Team. Ability to travel up to 50% to meet project needs. Experience in Neurosurgery and/or Rehabilitation plus.

Job Location

NY with travel to AL, DC, MD, PA, TX, TN, VA, WA

Type of Work

Full-Time

All interested candidates should send resumes and cover letters to: Dr. Emilia Bagiella Dept. of Biostatistics, Columbia University, 722 West 168^th Street, Room 635, New York, New York 10032.

Columbia University is an affirmative action/equal opportunity employer.