Senior Multi-Site Clinical Research Associate

extremitycare

United States

On-site

USD 85,000 - 125,000

Full time

3 days ago

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Job summary

extremitycare is seeking a Clinical Research Associate to oversee operational aspects of clinical trials at investigational sites in the United States. You will monitor data integrity, ensure regulatory compliance, and coordinate with sponsors and site personnel to keep trials on track.

The role requires a bachelor's degree in a relevant field, CRA certification is preferred, and up to 50% travel is expected.

Qualifications

Bachelor's degree in Clinical Research, Life Sciences or related field.
Certified as a CRA (CCRP/CCRA or equivalent) strongly preferred.
3 years of relevant industry experience or prior sponsor-clinic coordination experience.
Prior study supervision experience required.
Background investigation clearance required.
Valid Class C driver's license.
Up to 50% travel required.

Responsibilities

Oversee operational aspects of clinical trials at investigational sites to ensure data integrity and regulatory compliance.
Monitor multiple trials and sites simultaneously and maintain monitoring plans.
Liaise with investigators, staff, and sponsors to ensure study expectations are met from start to end.
Develop and review protocol drafts and informed consent documents for management.
Prepare site binder materials and closeout activities after trials.
Ensure adherence to FDA regulations, ICH-GCP, SOPs and regulatory requirements.