Senior CRA

Ryvu Therapeutics

Krakow, Poland

As a Senior CRA you will be part of the Clinical Operations team on the sponsor site, and you will monitor clinical trials in oncology and hematooncology indications, currently during early stages. As biotech organization we constantly work on preclinical candidates as well, therefore while working at Ryvu you will have a chance to broaden monitor responsibilities in the future and see the molecules development.

KEY RESPONSIBILITIES

Monitors clinical trials, supports and supervises investigators to ensure the studies are conducted in accordance with the study protocols.
Responsible for the daily clinical site activities; assists with resolution of investigational site/data issues and queries
Reviews study data in eCRF, provides questions and seeks clarification on data and data discrepancies
Performs essential document collection, review, maintenance and close-out activities, ensuring that study obligations are being met and are in compliance with applicable local regulatory requirements, ICH/GCP guidelines and SOPs
Assists in the development and/or review of the key study documents and reports, e.g. study plans, manuals, guidelines, study protocol
Performs pre-study, initiation, monitoring and closing visits to study sites performed
Supports other CRAs activities to ensure compliance with the study protocol and applicable regulations, integrity of the source data and completion of all applicable source documents.
Facilitates cooperation with CRO, sites, 3rd party vendors and Ryvu study team members
Organizes and participates in Investigators meetings and study team meetings
Monitors the amount of investigational product and supplies at clinical sites
Provides general support to the clinical team members in order to manage the investigator sites and study data

YOUR BACKGROUND

Master's degree in the life sciences, chemistry or health related fields
Minimum 5 year experience in clinical research (pharma/biotech or CRO) in oncology/hematoncology therapeutic area, phase I experience would be 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

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