Clinical Research Specialist
2 tygodni temu
Company Overview
Ryvu Therapeutics is a clinical-stage drug discovery and development company focused on novel small molecule therapies that address emerging targets in oncology. As a leading biotech organization, we constantly work on preclinical candidates and innovative treatments.
Job Description
- We are seeking a highly skilled Senior Clinical Research Associate to join our Clinical Operations team on the sponsor site.
- As a Senior CRA, you will monitor clinical trials in oncology and hematooncology indications, currently during early stages.
Key Responsibilities
- Monitor clinical trials, support investigators to ensure studies are conducted according to ICH GCP and regulatory requirements.
- Responsible for daily clinical site management and monitoring in accordance with a Monitoring Plan.
- Conduct source data verification, review study data in eCRF, provide questions and seek clarification on data discrepancies.
- Perform essential document collection, review, maintenance, and close-out activities, ensuring compliance with applicable local regulations, ICH/GCP guidelines, and SOPs.
- Assist in developing and reviewing key study documents and reports, e.g., study plans, manuals, guidelines, and study protocols.
- Perform pre-study, initiation, monitoring, and closing visits to study sites.
- Support other CRAs' activities to ensure compliance with study protocol and applicable regulations, integrity of source data, and completion of all applicable source documents.
- Facilitate cooperation with CRO, sites, third-party vendors, and Ryvu study team members.
- Actively participate in Investigators meetings and study team meetings.
- Monitor investigational product and supplies at clinical sites.
- Provide general support to the clinical team members to manage investigator sites and study data.
Required Skills and Qualifications
- Master's degree in life sciences, chemistry, or health-related fields.
- Minimum 5 years of experience in clinical research (pharma/biotech or CRO) in oncology/hematooncology therapeutic area; phase I experience is a plus.
- Certified knowledge of GCP principles.
- Fluency in English.
- Ability to travel to clinical sites (6-8 times/month within Poland).
- Communication, collaboration, and problem-solving skills.
Benefits
- Work in one of the most innovative companies in the region with a proven track record and high perspective of growth.
- Collaborative and supportive work culture.
- Training program enabling scientific development: Ryvu Academy, scientific lectures, participation in conferences.
- Package of benefits: Luxmed, Multisport, and many others.
- Onsite support for foreigners and help with relocation.
- Mindgram - wellbeing platform.
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