In-House Clinical Research Associate
Overview:
The In-House CRA role is a core member of the project team. This position will work with the project manager, Lead CRA and travelling CRAs on a clinical trial to ensure that monitoring activities are properly supported and that critical documents are being tracked, collected, and reviewed. This position will also be responsible for managing data entered into the clinical trials management system (CTMS) and other project tracking tools.
The In-House CRA will be responsible for assisting 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. They will also be responsible for mentoring other team members.
Responsibilities
- 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
- Will 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
- BA/BS, preferably in a life science, nursing, pharmacy or related field
- A minimum of one year of direct work experience managing essential documents within the CRO, pharmaceutical, or biotechnology industry
- Attention to detail
- Ability to set priorities and work independently
- Proficiency with office automation software including Microsoft Office and Adobe Acrobat and strong internet research skills
- Excellent organizational and multi-tasking skills
- Working knowledge of ICH E6, and the Code of Federal Regulations
- Strong written and verbal communications skills
- The ability to constructively interact directly with sponsor personnel
- Ability to travel as needed
Rho is a full-service contract research organization optimally sized to deliver results from clinical research with agility and adaptability. Maximizing profitability, stability, and planned growth has helped provide us with the experience, capacities, and capabilities of a larger organization—all without losing touch with our entrepreneurial passion.
Because Rho recognizes great people are our most important asset, we attract and retain the best and brightest.
Here's how we do it:
We are dedicated to a collaborative environment with fully integrated project teams and agile corporate leadership that ensures quick responses and follow-up. It is the combination of these elements that allows us to build and sustain an engaged and happy workforce. We are proud of our outstanding retention record; our talented employees tout work-life balance and close relationships with their colleagues and clients as primary reasons for joining our organization and growing their careers with us.
These are just some of the reasons Rho has consistently been named to the Triangle Business Journal's Best Places to Work.
By joining Rho, you will have the opportunity to work with some of the most talented minds in the industry to solve complex problems for our clients.
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