Clinical Research Associate - 100% Remote
Job title: Clinical Research Associate - 100% Remote
Duration: 6 months (Possible extension)
The candidate should be comfortable working across time zones (East to West), including EST, PST, or CST.
What are the top skills, experience or education required for this position:
- Prior work with company
- Medical Device Experience
- Attention to Detail
- Great Communication Skills
- Phase IV Experience
- Experience with clinical software such as Tesla, Veeva, electronic reporting, and EDC systems is highly valued.
- Comfortable with 30% travel, managing multiple sites, and direct interactions with site staff to ensure protocol compliance and timely visits.
Description:
- This is a CRA II position supporting a Phase IV study in the medical device space.
- The CRA will support on-site monitoring visits with 100% source data verification (SDV), not centralized monitoring.
- This role is site-facing and technically focused, with direct monitoring responsibilities and minimal internal or administrative work.
- The study will involve up to 9 clinical sites, but realistically, the number will be closer to 6 sites, and each CRA may be responsible for 3 to 4 - Sites will be regionally assigned if possible, depending on the CRA's location.
- Member of the clinical team responsible for conducting Phase I-IV single or multi center studies according to Federal Regulations and ICH guidelines.
- Responsible for assisting senior staff in planning study conduct, designing case report forms (CRFs), Contract Research Organization (CRO) selection and management, selection and training of investigator sites, planning and running study meetings, evaluation, selection and training of new study investigators and writing and assembling submissions.
- Responsible for monitoring or overseeing monitoring of investigational sites to ensure protocol adherence, assuring timely enrollment of patients and retrieval of CRFs from study sites, processing CRFs including data cleanup and classification of data, and completion of study summary.
Helping all candidates find great careers is our goal. The information you provide here is secure and confidential.
We are now directing you to the original job posting. Please apply directly for this job at the employer’s website.