We bring breakthrough pioneering therapies to patient with life threatening diseases
Celyad is a biopharmaceutical clinical-stage company, specialized in the development and engineering of cell-based therapies. Our ambition is to develop a unique immunotherapeutic approach to offer new treatment options to cancer patients. Our team is currently focusing on the development of a new T-cell therapy that has the potential to target and destroy 80% of cancer types.
Celyad unites passionate people who keep on pushing the boundaries of innovation, leveraging unique scientific know-how from Research & Development to Phase III clinical trials, as well as a strong expertise in cell manufacturing and logistics.
Based in Europe and in the U.S., Celyad offers a nice working environment as well as the opportunity to interact with colleagues and stakeholders involved at each step of the product development. Our Company surrounds itself with the best industrial and academic partners (Mayo Clinic, Dartmouth College, ONO Pharmaceutical, Institute Curie) to explore the full potential of its technological platform.
At Celyad, we know that every second counts for the patients and their families, and that is what drives us in our work every single day. Ready to take up this challenge?
Great! Celyad is looking for an enthusiastic:
Senior Clinical Research Associate (M/F)
The successful candidate will be based on the East Coast (USA).
Role & Responsibilities
- Clinical Site Start up
- Support identification of clinical sites, feasibility research, tracking of clinical site activities
- Perform operational feasibility
- Prepare and submit packages for Institutional Review Board (IRB)/Scientific Review Committee (SRC)/Institutional Biosafety Committee (IBC)
- Organize, prepare, perform, and follow-up of Site Qualification visits (SQV), Site Initiation visits (SIVs), plus maintain appropriate documentation.
- Clinical Site Management
- Conduct monitoring and close-out visits, plus maintain appropriate documentation
- Establish regular lines of communication plus administer protocol and related study training to assigned sites
- Evaluate the quality and integrity of site practices and – escalate quality issues as appropriate
- Manage clinical site progress by tracking regulatory submissions, recruitment, case report form (CRF) completion, and data query resolution
- Act as the direct contact with assigned clinical sites, and use judgment to assess and ensure overall integrity of study implementation, as well as adherence to study protocol
- Manage clinical monitoring activities, including:
- Arrange on-site visits and logistics
- Establish of a site recruitment plan in collaboration with site staff during SQV
- Monitor completeness and quality of Regulatory Documentation
- Perform site documentation verification
- Collect data and drug accountability in accordance with ICH GCP guidelines
- Monitor participant safety on-site and address any violations in a timely manner
- Support clinical supply chain
- Prepare for and attend audits; implement of corrective actions
Qualifications & Experience
- Bachelor or Master degree in a (para-) medical or scientific field or equivalent combined education and experience
- Minimum 2 years of independent monitoring experience in the US
- Experience in oncology trials both solid and hematological indications
- Experience in cell therapy trials is an advantage
- Strong working knowledge of applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP), International Conference on Harmonization (ICH) Guidelines, and FDA regulations
- ACRP/CCRA or equivalent certification/credentials preferred
Skills & Competencies
- Very strong attention to details
- Work precisely as per procedures, rules and regulations
- Affinity to administration
- Objective and analytical
- Planning & Organizing skills
- Team spirit
- Strong communication skills
- Hands-on attitude
- National travel is required regularly, international travel might be required occasionally
- Remote based position