Buscar empleo: 10 ofertas de trabajo de Éducation en Massy (abril 2026)

Clinical Trial Associate

hace 3 días

Massy

About Corteria Pharmaceuticals Corteria Pharmaceuticals is a privately held company that develops first-in-class drugs in subpopulations of heart failure. Our strategy involves innovative stratification of patients and selection of our targets based human validation. We use state-of-the-art methods to stratify patients and identify those who will benefit most from our treatments. Our programs aim to treat well defined heart failure subpopulations (worsening heart failure, acute heart failure with hyponatremia, right heart failure) and obesity with co-morbidities. We develop several candidates around clinically validated targets CRF2 and vasopressin • CRF2 projects: endogenous CRF2 ligands (urocortin 2 or stresscopin) have been validated in heart failure patients but their very short half-life which makes them unsuitable for subchronic use. Our strategy is to develop potent, selective, long-acting CRF2 agonists suitable for subcutaneous administration for the treatment of worsening heart failure or obesity with comorbidities., • · Vasopressin project: therapeutic targeting of vasopressin requires the blockade of its 3 receptors (V1a, V1b, V2) which cannot be achieved today by a small molecule approach. To overcome this issue we are developing a neutralizing human monoclonal antibody directed against vasopressin. We are seeking a clinical trial associate to join our dynamic team. The candidate will be responsible for assisting and providing support to the members of the clinical operations project team (i.e. Clinical Operations Directors (COD), the Clinical Research Directors (CRDs)) and to the CMC team (CMC Project Leader), in order to facilitate the management of clinical trial processes. The Clinical Trial Associate (CTA) will assist in supporting the conduct of trials and may be responsible for managing specific study and operational tasks. The CTA will perform work within established processes and under general supervision. He/she will report to a COD with a dotted line to CMC Project Leader. Missions and Responsibilities: • Liaise with team to ensure Clintrials.gov is updated accordingly with current site statuses, • Participate in creation and distribution of sponsor specific study aides/materials and communications, • Collate documents required for the submissions, • Assist with initial review of study plans and documents, • Assist with initial review of site-specific budgets and ICFs with appropriate oversight by COD, • Perform eTMF and other study specific trainings as appropriate., • Liaise as needed with CTAs and other study members of the CROs for study set-up, • Assist on study set-up logistics and supplying activities, • Participate to internal and external study meetings as appropriate, • Study Maintenance, • Assist COD in tracking study related activities which are not outsourced, • Agenda distribution & minute taking for internal and external study team meetings, • Support blinded SUSAR distribution, • Maintain internal & external contacts lists, • Facilitate contract review and execution, • Assist on study logistics and supplies maintenance, • Perform regular eTMF oversight and resolve potential gaps. Assist with Audit/Inspections and ensure inspection readiness of the TMF., • Liaise with CRO study members as needed, • Maintain classification of essential study documents in the internal SharePoint updated, • Manage related task specific study vendor, • Create study or task related documents, • Assist with study management tasks such as co-monitoring visits, clinical documents, monitoring report reviews, ICF generation and/or review, review IP release package, etc., • Coordinate and review CRF queries with the COD., • Tracking and management of clinical events, • Shipping and storage Document checks: Confirm and document IP receipt at depot/clinical sites, IP storage conditions, including temperature logs., • Event Identification: Immediately flag and report any event (eg temperature excursions, breach in blinding…) in dedicated form and tracker for further internal evaluation., • Root Cause Analysis: Coordinate and assist in investigating the cause of the events., • Corrective Actions: Coordinate with CRO, sites and SME team to implement any needed CAPA., • Tracking and reporting: Ensure all event documentation and actions are archived. Prepare and maintain a tracking log of events eg “cumulative temperature excursion file” for each study, • Study Close Out, • Assist study team with preparation for audits/inspections, • Assist study team in close out, • Liaise with team to ensure Clintrials.gov and results are updated/distributed accordingly, • Collaborate with Corteria team for the archiving of clinical documentation., • Departmental Tasks:, • Act as team super user for study SharePoint, • Maintain up to date training, • Participate in inter-departmental workgroups to create or enhance processes, • Take on career developmental activities/tasks as necessary Key Skills, Abilities, and Competencies • Professional fluency and effective written and verbal communication skills of the English language., • Relevant experience in clinical research or related field, • Adequate Good Clinical Practice training, • General knowledge of regulatory requirements and guidelines governing clinical research, • Comfortable with technology and ability to learn new systems quickly, • Strong knowledge of MS Word, Excel, PowerPoint and Outlook, • Requires strong attention to detail in composing and proofing materials, establishing priorities, scheduling and meeting deadlines, • Must be able to professionally interact and communicate with visitors, vendors and individuals at all levels of the organization, • Must be able to work in a fast-paced environment with demonstrated ability to juggle multiple competing tasks and demands, • Ability to work successfully within a cross-functional team, • Understanding how their input and role coordinate more effective business practices for the program’s business overall and committing to the culture, vision and mission of Corteria, • Ability to present clinical information in a professional forum, • Ability to take ownership and manage tasks as well as communicate effectively, • Ability to work with minimal supervision and complete tasks to deadlines, • Demonstrate ability to lead cross functional workgroups Education and Experience Requirements • Bachelor's degree or equivalent and/or equivalent relative experience required, • Minimum 2-4 years’ experience in supporting or managing tasks within clinical trials, • Experience utilizing EDC, TMF, CTMS, and related software preferred., • Proficient in Microsoft suite of products; Microsoft Word, Excel, PowerPoint, Outlook, • Excellent communication, interpersonal skills and collaborate effectively across functions.

Trabajos Éducation en MassyCrear alertas

Búsquedas de empleo más populares en Massy