Founded in 2009, CryoTherapeutics is an early stage European innovative company that is now establishing its operations in Awans (Liège). The company is in the process of developing a novel catheter system to treat atherosclerotic plaque that causes heart attacks by delivering cryoenergy to the coronary arteries.
CryoTherapeutics recently raised 7M€ in its latest round of financing and will use these funds to continue the development of this technology with the aim of starting additional clinical studies later this year. For additional information about the company, please visit http://www.cryotherapeutics.com/
In order to support the expansion of the team in Awans, we are looking:
Clinical Project Coordinator
Reporting to and working closely with the Director of Regulatory and Clinical Affairs, as Clinical Project Coordinator, you are responsible for the operational management and the oversight of clinical trials according to the clinical strategy.
Your main responsibilities are :
- Support clinical trials, including set-up of clinical documentation (protocol, investigator’s brochure, clinical QMS), site selection and qualification of investigators, EC/CA submission and regulatory reporting.
- Facilitate and support staff for trial initiation, patient enrollment, compliance to the study protocol and use of the electronic database.
- Ensure that physicians and staff are well trained and educated , and assist in clinical cases.
- Ensure site monitoring, including scheduled visits, events reporting and documented interactions with clinical sites.
- Compile required clinical documentation for regulatory submissions.
- Work closely with the research team to ensure that all study procedures and visits occur as required in the protocol and timely entry of the data in the electronic database.
- Represent the company in all regulatory and third party audits for clinical activities.
- Deal with product-related site request and solve issues.
- Engage with physicians and clinical staff, build relations and credibility.
- Report results and work evolution on a regular basis to your line manager.
- Master’s degree in Biomedical Sciences, Bioengineering or any related field.
- 3-7 years as Clinical Research Assistant or Clinical Project Leader at country or European level.
- CRA/GCP training, preferably Medical Device GCP (ISO14155), and knowledgeable about regulatory requirements of medical device studies.
- Experience in clinical trials for cardiovascular medical devices and/or ability to manage cases in cath lab is an asset.
- Keen interest in scientific and technical issues related to clinical study.
- Ability to work and collaborate effectively with internal and external actors.
- Flexible, roll-up-sleeves attitude, self-directed and willing to travel when needed.
- Excellent oral and written communication skills in English. Any other language is a plus.
- Up to 30% travel may be required.
- A challenging position with a high potential innovative medical device company.
- To work in a human-sized, collaborative and respectful environment
- A variety of interesting contacts with international exposure.
- An attractive compensation package in line with the position’s responsibilities and your experience.