CLINICAL RESEARCH ASSOCIATE
hace 3 días
Barcelona
Clinical Research Associate (CRA) About the Role We are seeking a motivated and detail-oriented Clinical Research Associate (CRA) to join our team. The selected candidate will support the planning, monitoring, and execution of clinical studies, ensuring compliance with Good Clinical Practice (GCP), regulatory requirements, and internal quality standards. This is an excellent opportunity for growth, with on-the-job training and mentorship provided. Key Responsibilities • Act as the main point of contact and support for the assigned investigational sites., • Prepare, conduct, and report remote and onsite monitoring visits in accordance with the Monitoring Plan and applicable SOPs., • Assess investigational site performance and ensure compliance with study protocol, GCP, and regulatory requirements., • Perform all required activities during monitoring visits according to internal and/or sponsor procedures., • Document and track the management of issues and deviations identified during and between site visits., • Support investigational site staff in the resolution of issues/deviations and the development of Corrective and Preventive Action (CAPA) plans., • Collaborate with Biometry, Regulatory Affairs, and Safety departments to obtain necessary site documentation. Key Interfaces • All departments within the Operations area. Education • University degree in Medicine, Biology, Biochemistry, Pharmacy, Nursing, Psychology, Chemistry, or other life science fields., • Master’s degree in Clinical Study Monitoring or an equivalent qualification. Training Requirements • Solid understanding of Good Clinical Practice (GCP)., • Knowledge of the regulatory framework governing clinical studies., • Understanding of data protection regulations applicable to clinical research. Experience • Minimum 1 year of experience as a CRA., • Candidates with strong interest in clinical trials will also be considered; training and mentorship will be provided., • Desirable experience in clinical investigations with medical devices., • Desirable experience using electronic platforms, including eCTMS and eTMF. Languages • Spanish, • Advanced English level (spoken and written). Other Requirements • Knowledge of established quality standards and ability to follow internal instructions., • Proactive attitude with a willingness to contribute to continuous improvement., • Familiarity with cloud-based IT platforms and digital tools., • Strong communication, reporting, and interpersonal skills., • Comfortable working within multidisciplinary teams., • Excellent organizational skills, independence, and strong time-management abilities., • Effective active listening and negotiation capabilities., • Rigorous, detail-oriented, and problem-solving oriented., • Sound decision-making and ability to manage complex situations. Working conditions • Full time position, • Offices located in Barcelona, • Hybrid work, • Competitive salary, • Exclusive employee discount club, giving you special benefits and discounts across a wide range of products and services.
124 Carrer de Roger de Llúria, Eixample, 08037, Barcelona
