In-House Clinical Research Associate
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US
Company:
Rho offers innovative clinical research operations with a focus on collaboration and quality in the development of medical treatments.
Summary:
The In-House Clinical Research Associate will support clinical trials by managing documentation and assisting CRAs in ensuring compliance with regulations. Candidates need a Bachelor’s degree in a relevant field and at least 1 year of experience in the industry.
Requirements:
Hard Skills: knowledge of clinical research process, understanding of regulatory and ethics submission processes, knowledge of current ICH GCP guidelines and regulations
Credentials: Bachelors Degree in a life science, nursing or pharmacy field
Experience: at least 1 year of direct work experience managing essential documents within the CRO, pharma or biotech industry
Job Description:
Description
Join us in redefining what it means to work for a CRO.
When you work at Rho, it’s more than just a job—you become part of the Rho Factor. We’re a proud bunch of science nerds who love tackling big challenges together. We’re not your typical CRO, and we’re not trying to be. Here, curiosity is encouraged, fresh approaches are welcome, and collaboration is at the heart of everything we do.
Whether you’re a data wizard, analytical genius, project mastermind, or any other role, you’ll fit right into the equation of the Rho Factor. Expect plenty of geeky jokes, eccentric personalities, spontaneous brainstorms, and a supportive community where people genuinely care about their work—and each other.
You’ll have the opportunity to experience a thriving company with real stability - financial, workforce, and corporate, which has created a safe environment to innovate and develop over a long and rewarding career.
We are currently hiring an In-House Clinical Research Associate to join our team! As an In-House CRA here at Rho, you’ll have the opportunity to gain the necessary experience to grow into a traveling Clinical Research Associate (CRA) and work with the Project Manager, traveling CRAs and Lead CRA on a clinical trial to ensure that monitoring activities are properly supported and that critical documents are being tracked, collected, and reviewed. You’ll manage data entered into the CTMS (clinical trials management system) and other project tracking tools. You’ll also assist CRAs on query resolution and data reviews to ensure that studies operate in compliance with study protocols, Rho SOPs, ICH/GCP guidelines, and federal regulations. You may also have the opportunity to mentor other team members.
Our Clinical Operations Team will tell you, joining Rho has been one of their best career moves in terms of contentment, financial rewards and career growth, which is why we have such stability in the group!
What you'll be doing:
- Collect, track and review investigational site records relating to subject screening and enrollment
- Assist in the development of study plans and status reports
- Collect, track, and review all site regulatory documents
- Assist with development and review of Informed Consent Forms
- Interact with sites, clients, vendors and internal study team members
- Maintain the clinical trials management system (CTMS) and other project tracking tools
- Track study supplies and coordinate shipments of supplies to sites as needed
- Manage the study Trial Master File (TMF) and ensure periodic TMF audits
- Coordinate work with CRAs monitoring on-site
- Perform on site co-monitoring and remote monitoring activities
- Perform regular reviews of data entered by investigational site staff according to data review/monitoring guidelines