Clinical Research Associate
About The Position
About Us: Eupraxia is a clinical-stage biotechnology company focused on developing locally delivered, extended-release products that have the potential to address therapeutic areas with high unmet medical need. DiffuSphere™, a proprietary, polymer-based micro-sphere technology, is designed to facilitate targeted drug delivery of both existing and novel drugs. The technology is designed to support an extended duration of effect and delivery of drugs in a hyper-localized fashion, targeting only the tissues that physicians want to treat. We believe the potential for fewer adverse events may be achieved through the precision targeting and the stable and flat delivery of the active ingredient when using the DiffuSphere™ technology, versus the peaks and troughs seen with more traditional drug delivery methods. The precision of Eupraxia's DiffuSphere™ technology platform has the potential to augment and transform existing FDA-approved drugs to improve their safety, tolerability, efficacy and duration of effect. The potential uses in therapeutic areas may go beyond pain and inflammatory gastrointestinal disease, where Eupraxia currently is developing advanced treatments, also to be applicable in oncology, infectious disease and other critical disease areas. Eupraxia's EP-104GI is currently in a Phase 1b/2 trial, the RESOLVE trial, for the treatment of EoE. EP-104GI is administered as an injection into the esophageal wall, providing local delivery of drug. This is a unique treatment approach for EoE. Eupraxia also recently completed a Phase 2b clinical trial (SPRINGBOARD) of EP-104IAR for the treatment of pain due to knee osteoarthritis. The trial met its primary endpoint and three of the four secondary endpoints. In addition, Eupraxia is developing a pipeline of later and earlier-stage long-acting formulations. Potential pipeline indications include candidates for other inflammatory joint indications and oncology, each designed to improve on the activity and tolerability of currently approved drugs. For further details about Eupraxia, please visit the Company's website at: www.eupraxiapharma.com . Scope: As our Clinical Research Associate (CRA) you will be primarily responsible for the operational management and oversight of Eupraxia clinical study’s monitoring. Travel requirement: Must be willing to travel domestically and internationally (approximately 20-25%), as needed
Requirements
- BS/BA in life sciences or related discipline
- 5+ years pharma/biopharma industry experience, preferably in a sponsor-side role
- 1+ years of active, independent, on-site monitoring experience for all types of visits
- Strong working knowledge of FDA and ICH/GCP regulations and guidelines
- Thorough knowledge of clinical monitoring procedures
- Strong interpersonal, communication (written and verbal), and organizational skills
- Excellent analytical and assessment skills, judgment, and problem-solving skills
Responsibilities
- Assisting Clinical Trial Manager in ensuring trials are initiated efficiently, completed on time, within budget and conducted in compliance with SOPs, regulations, and ICH/GCP guidelines
- Assisting Clinical Trial Manager in managing CRO partners and other vendors
- Working closely with and providing training to CRO staff, study site staff, and field-based CRAs
- Overseeing, conducting, and/or co-monitoring site qualification, study initiation, interim monitoring, and close out visits and completing associated reports
- Developing and/or assisting in the development of trial materials (e.g., protocol, informed consent forms, case report forms (CRF), CRF completion guidelines, monitoring guidelines, site initiation visit materials, site tools and worksheets, product administration guidelines)
- Reviewing monitoring reports and monitoring visit letters written by CRO CRAs
- Driving CRO and trial sites with study startup activities, including IRB/IEC submissions and ensuring collection and review of required essential documents
- Creating, monitoring, and sharing key performance metrics with study teams
- Reviewing completed CRFs and data listings for accuracy, overseeing data discrepancy management, and performing associated training/retraining to site staff and CRAs as needed
- Developing strong and effective working relationships within Clinical Operations and other functional departments and CROs
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
1-10 employees
