CERC has started to implement the Colibri Heart Valve CE mark trial. This balloon-expandable THV was designed with an original leaflet geometry and material enabling a reduction in the mass of cusps with the potential benefit of a larger effective orifice area even in out-of-round shapes of the frame. In combination with proprietary dry tissue preparation, this allows for a pre-mounted, pre-packaged, low profile (true 14F) delivery system. This company-sponsored trial will be conducted in ten centers in four European countries in order to enrol 60 patients with a 1-year primary endpoint and 5-year clinical and echographic follow-up. About the trial...
clinical research associate The European Center for Cardiovascular Research (CERC) is a CRO specialized in the design and management of international clinical trials dedicated to cardiovascular diseases. Chaired by four interventional cardiologists, actors of clinical research for over 20 years, the CERC conducted clinical studies directly in line with the issues of cardiologists practicing in private or public hospitals. CERC is currently supporting thirty studies for industrial promotions but also manages more than 10 “investigators initiated trials” whose purpose is the treatment of conditions / comorbidities for which there is no satisfactory therapeutic strategy. CERC is an Entreprise à Mission. CERC is currently looking for Clinical Research Associates to be involved in international clinical studies. Job description – Responsible for site management from initiation to close-out in accordance with study specific procedures, applicable SOPs, and ICH GCP guidelines – Remote monitoring via e-CRF – Training and information for investigators and the clinical study – Privileged contact with investigators centers – On site monitoring of patient safety (review of SAEs, AEs) – Generate visit reports in compliance with the monitoring plan – Update all relevant tracking systems on an ongoing basis – May assist the Clinical Project Leader in regulatory submissions. Qualifications Skills – Excellent interpersonal, verbal and written communication skills – Ability to prioritize multiple tasks and achieve project timelines – Ability to take initiative and work autonomously – Computer skills (Microsoft Office) Education – A Master or higher graduate degree within a science related field, with a CRA training – Significant experience in performing a Clinical Research Associate role at least 1 year minimum. Language Skills Competent in...
Clinical Project Leader Clinical Project Leader The European Center for Cardiovascular Research (CERC) is a CRO specialized in the design and management of international clinical trials dedicated to cardiovascular diseases. Chaired by four interventional cardiologists who have been key clinical research investigators for more than 20 years, the CERC conducts clinical studies specifically designed to address the issues faced by interventional cardiologists in both the public and private sectors. CERC is currently managing thirty studies sponsored by the industry, as well as more than 10 “investigator-initiated trials” set up to find treatments for conditions / comorbidities for which no satisfactory therapeutic strategies have yet been developed. CERC is an Entreprise à Mission. As the current expansion of our activities is generating new requirements for additional team resources, we are seeking to hire an experienced Clinical Project Leader: Job description Set-up, coordination and follow-up of domestic or international clinical trials in the medical device field Design/drafting of scientific documents (protocols, information to patients, case report forms) Preparation and submission of regulatory files Coordination of internal and external staff resources Supervision and follow-up of monitoring activities Compliance with timelines Exhaustive preparation of all required study documents Follow-up of study budgets Required qualifications and skills Scientific background (Master’s Degree or higher) Previous experience in the management of international clinical trial projects Proficiency in oral and written English (a third language would be appreciated) Interpersonal and organizational skills Working conditions Work from home: one day a week, and more in case of pandemy Flexible working hours 12 reasons for joining us👉 https://www.cerc-europe.org/12-reasons/ Nature of employment: permanent contract The position is available...
QUALITY POLICY The CERC offers to the Medical Device and Pharmaceutical Industries and academia, a scientific research organisation devoted to advanced and complex clinical developments, specifically in the cardiovascular diseases area in an international context. With offices providing services in about 40 countries, our team has a strong knowledge of local regulations, standards of care and customer’s culture to deliver the highest quality of work for studies we are entrusted. This Quality policy applies to all employees within CERC and CERC Asia as well as other third parties working on behalf of CERC. In order to provide our Clients with high-quality services, we have implemented a Quality and Process Management System able to: guarantee compliance with the applicable regulations, meets the Client’s expectations and requirements regarding the services provided, ensure the continuous improvement in our process and procedures We commit to: ensure compliance with applicable regulations, continuously improve the effectiveness of our system ensure compliance with the timelines defined with our clients, ensure continuous support to our clients and other interested parties, provide required services and go beyond our expectations enhance the competence of CERC staff strengthen the CERC knowledge by having the staff turnover as low as possible. The maintenance of CERC Quality and Process Management System is performed by CERC Quality Team. Meeting Client satisfaction and service requirements also resides in the implication of each individual within CERC. We, therefore, trust each staff member to actively participate in the setting forth of this quality policy and in the Quality Management System, for the benefit of Client satisfaction, for meeting the services objectives, and thus for the benefit...
Clinical TRIAL Assistant The European Center for Cardiovascular Research (CERC) is a CRO specialized in the design and management of international clinical trials dedicated to cardiovascular diseases. Chaired by four interventional cardiologists, actors of clinical research for over 20 years, the CERC conducted clinical studies directly in line with the issues of cardiologists practicing in private or public hospitals. CERC is currently supporting thirty studies for industrial promotions but also manages more than 10 “investigators initiated trials” whose purpose is the treatment of conditions / comorbidities for which there is no satisfactory therapeutic strategy. CERC is currently looking for an office-based clinical trial assistant. Job description Perform general administrative tasks related to studies, upon request from Clinical Project Leaders Set up appropriate tracking tools Follow-up and tracking of all essential study documentation Maintenance of clinical studies files in order to ensure an appropriate filing of all study documents Follow-up of Investigator’s, subcontractor’s and committees members fees, upon request from Clinical Project Leaders Organization of meetings, teleconferences and booking of hotels for Clinical project Leaders Order specific supplies for studies Skills Assistant Degree Fluent English Good computer skills The position is available immediately and is based in Massy, Essonne (91), France 12 reasons for joining us👉 https://www.cerc-europe.org/12-reasons/ INTERESTED ? RESUME COVER...
