Location: Villeneuve d’Ascq - France
Requested experience: at least 5 years as clinical coordinator
Hemerion Therapeutics is a clinical stage company specialized in Biotech. Hemerion results of over 10 years of leading academic and clinical researches on innovative approaches to treat Glioblastoma. These new technologies have been evaluated to treat brain cancer through a first-in-human clinical trial. Hemerion owns a unique and disruptive technology, already evaluated in frontline approach to treat patients harboring brain cancer.
Today, to support its development, Hemerion looks for his/her clinical trial coordinator.
We are looking for a Clinical Research Coordinator to follow, support and develop our clinical strategy according to good clinical practice (GCP).
Position and responsibilities
Under the supervision of the CEO you will be in charge of structuring our clinical department. You will be responsible for supporting study implementation and ensuring each study is in compliance with the protocol, good clinical practice, regulatory requirements, and Hemerion standard operating procedures. You will own administrative day-to-day project activities that support one or more clinical trials, including the budget follow-up and update as well as the data protection policy.
As a Clinical Research Coordinator, you will embody the link between principal investigators of our clinical studies and Hemerion’s team. In collaboration with our regulatory affairs, biostatistics and CRO partners, your missions are the following:
- To oversee and ensuring that clinical investigations are performed in accordance with the MDR 2017/745 and ISO 14155 standard and be able to respond to any audit
- To manage, follow-up and closeout all clinical projects during their progression and validate all steps previously defined
- To define appropriate budget in collaboration with our regulatory strategy
- To set-up and maintain up-to-date all documents of the QMS
- To contribute and maintain awareness of relevant clinical regulatory legislation and assess the impact of new standards and participate in the implementation of actions in the QMS
- To participate to set-up the ISO 14971
- To manage day-to-day clinical project activities, including monitoring and updating the budget and data protection policy
- Excellent knowledge of ISO 14155, Good Clinical Practice and US regulations for clinical trials
- Fluent in English and French for daily contacts with local and international partners
- Excellent organizational, communication and interpersonal skills
- Ability to work well within a team
PhD, engineer or equivalent degree, you have at least 5 years of experience in clinical investigations as trial coordinator. You must be experienced in conducting clinical research to obtain MA supporting Hemerion’s regulatory strategy. A good knowledge of both European and American regulations would be appreciated.
- Dynamic environment with opportunities for advancement within the company
- International and growing company
- Flexible working environment
- Health insurance