Experienced Regulatory Affairs Coordinator/Contractor (Must have Clinical Research Experience)

Regulatory Coordinator/Contractor for Clinical Research studies (at the Site level)

MUST have prior experience and understand Clinical Research studies from the Site level.

MUST have experience in Site start up activities and Site close outs

Responsible for:

· Move study from feasibility questionnaire to study activation

· Including IRB submissions, Regulatory documents, ICF preparation, Site qualification visit, site initiation visit, preparing site regulatory binder.

· Maintain study startup tracker

· Clinical trial billing

· Clinical trial agreement

· Assist in budget negotiation

· Maintain the clinical trial pipeline

· Quality assurance of each visit done by the coordinator

· Maintain proper audit log

o Setting up process flow for each trial

o Setting up billing structure

o Setting up clinical research dept and SOP’s

o CRIO, Confluence

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Job Types: Full-time, Contract, Part-time

Pay: $30.00 - $40.00 per hour

Education:

• Bachelor's (Preferred)

Experience:

• Clinical Trials: 1 year (Preferred)
• Clinical Research: 1 year (Preferred)

Work Location: In person