Bioxodes is a Belgian-based biotech start-up specialized in the development of novel therapeutics using molecules derived from nature to prevent thrombosis and inflammatory processes. The company’s initial focus is Ir-CPI, a unique antithrombotic molecule offering a remarkable and unprecedented balance between antithrombotic benefit and haemorrhagic side effect.
Bioxodes has an exciting career opportunity (full-time position) for a motivated individual as a Clinical Research Associate (M/F) to join a well-integrated and dynamic team.
Bioxodes is looking for an experienced Clinical Research Associate who will interact with CRO and vendors in collaboration with Bioxodes team in the framework of a Phase I clinical trial. The candidate must then be able to work both independently and in a team environment.
• Make sure that the conduct of the study is in compliance with the currently approved protocol/amendment(s), with ICH GCP, SOPs, regulatory guidelines and working practices.
• Author, input and/or review study specific documents such as Protocol, Monitoring Guidelines, CRF Completion Guidelines, Patient Information and Informed Consent Form, SOPs, standard forms and templates.
• Review of Trial Master File (TMF) and ensure that all documents are in order, logical, accurate, complete, up-to-date and ready for a study audit and/or inspection.
• Help the team in the preparation of documents for the submission to the Independent Ethics Committees and to Competent/Regulatory Authorities.
• Assists the team in CRO, vendors, labs and clinical site selection and management: Request for Proposal, discussion, meetings, phone contacts, contracts, budget negotiation, payments, etc.
• Conduct site qualification visits (pre-study visits), site initiation, site close out visits and regular oversight monitoring visits.
• Maintain close contact with the investigators on-site, the study center coordinator, the pharmacist and other involved parties.
• Proactively address risk-based management approach applied in clinical trial and associated procedures.
• Provide clinical project/study related specific training/mentoring to team members, notably according to regulatory documentation process.
• Have to manage and help team to deal with regulatory and mandatory documents related to Clinical Trial in accordance with the Good Clinical Practices, Regulatory Approval Processes, GDPR, ISO, Good Clinical Data Management Practices, etc.
• Participate in the validation of data management systems (eCRF), reporting (SAP, TFL specification, analysis set classifications and dataset specifications) and in the blinded review of data.
The required skills and experiences are:
• Required Minimum Education: BS degree in Life Sciences. MS degree or PhD being preferred. 5-10 years of monitoring experience in clinical research is mandatory (preferably Phase I).
• Knowledge of GCP, ICH guidelines and regulatory requirements for clinical trials.
• Native speaker: French with excellent verbal and written communication in English (Dutch is an asset).
• Basic principles of data management and statistics.
• Proactive approach, time management and organizational skills as well as excellent interpersonal skills and ability to handle team dynamics.
What we offer :
• Immediate start.
• Full-time position.
• Attractive salary conditions will be offered.
• This role will be mainly office-based (Gosselies) except for visit monitoring and external meetings.
• If you feel that you possess the relevant skills and working background please send a CV, contact information for 3 references and covering letter explaining your suitability for the position. Applications providing all of the requested information should be sent by e-mail to: [email protected].
• No UNSOLICITED PHONE CALLS OR E-MAILS PLEASE. Only those candidates who are deemed a close fit will be contacted, but all pertinent CVs will be maintained for a period of 6 months.