[Hiring] In-House Clinical Research Associate @Rho Inc

Role 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. Here, curiosity is encouraged, fresh approaches are welcome, and collaboration is at the heart of everything we do.

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.

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

Qualifications

• Bachelors Degree in a life science, nursing or pharmacy field
• At least 1 year of direct work experience managing essential documents within the CRO, pharma or biotech industry
• Good knowledge of clinical research process and an understanding of Regulatory and Central/Local ethic submission processes for assigned countries
• Working knowledge of current ICH GCP guidelines and applicable regulations
• Desire / Career Goal of growing into a traveling CRA role

Requirements

• Strong Communicator: Demonstrate written, verbal and presentation skills to help showcase the successes of your work and Rho’s; Fluency in both local language and English
• Committed to Quality: Attention to detail, a deep understanding of high-quality scientific standards, and an ability to care about every outcome
• High-Character: Contribute to a collaborative culture with honesty and integrity, valuing loyalty, accountability, and mutual trust
• Critical Thinker: Evaluate situations and opportunities objectively and craft novel, practical solutions
• Agile and Adaptable: Ability to change quickly, respond to, and take advantage of changes in the environment

Benefits

• Flexibility: Encouragement of a work-life balance that allows employees to bring their best selves to work