<p></p><p><b> Clinical Research & Technical Associate (CRA / CTA)</b></p><p></p><p><b> Position Overview </b></p><p> We are seeking a Clinical Research & Technical Associate (CRA/CTA) to join a dynamic, science-driven consulting environment. This role combines on-site monitoring responsibilities with essential administrative and documentation support across the full lifecycle of observational studies. </p><p> The successful candidate will play a key role in ensuring quality, regulatory compliance, and data integrity, acting as a central point of coordination between investigators, sponsors, project managers, and ethics committees. </p><p></p><p></p><p><b> Key Responsibilities </b></p><p></p><p><b> Study Start-Up & Regulatory Affairs </b></p><ul><li> Prepare, compile, and submit study documentation to Ethics Committees (CEIm) and relevant regulatory authorities in accordance with applicable legislation (e.g., Royal Decree 957/2020, GDPR). </li><li> Draft, review, and track contracts, amendments, and informed consent forms. </li><li> Coordinate site initiation activities, including preparation of study start-up packages and Investigator Site Files (ISF). </li><li> Liaise with regulatory bodies to ensure timely approvals and ongoing compliance. </li></ul><p></p><p><b> Document Management </b></p><ul><li> Maintain and organise Trial Master File (TMF) and Investigator Site Files (ISF) ensuring accurate filing, version control, and traceability. </li><li> Manage electronic Trial Master File (eTMF) systems and perform periodic quality checks. </li><li> Ensure completeness of regulatory and study-specific documentation. </li><li> Support document archiving at study close-out in line with retention policies. </li></ul><p></p><p><b> Site Monitoring & Coordination </b></p><ul><li> Monitor study sites to ensure adherence to protocols, ICH-GCP guidelines, and local regulations. </li><li> Conduct site initiation, monitoring, and close-out visits, including reporting and follow-up actions. </li><li> Support participant screening via medical record review and coordination with healthcare professionals. </li><li> Act as a point of contact for site staff, sponsors, and vendors. </li><li> Track enrolment and proactively manage recruitment or compliance issues. </li></ul><p></p><p><b> Data Management </b></p><ul><li> Review and validate Case Report Forms (CRFs) ensuring consistency with source data. </li><li> Assist with data entry and resolution of queries in collaboration with data management teams. </li><li> Ensure timely and accurate data transfer and compliance with EDC systems. </li><li> Support sites in meeting data quality and system requirements. </li></ul><p></p><p><b> Compliance & Quality Assurance </b></p><ul><li> Ensure study activities comply with ICH-GCP, EU and Spanish regulations, and internal procedures. </li><li> Safeguard patient rights, safety, and wellbeing throughout study participation. </li><li> Support audit and inspection readiness activities. </li><li> Ensure adherence to data protection regulations (GDPR). </li></ul><p></p><p><b> Reporting & Scientific Dissemination </b></p><ul><li> Contribute to the preparation of clinical study reports and regulatory documentation. </li><li> Support development of scientific publications, abstracts, and congress materials. </li><li> Participate in feasibility assessments and proposal development. </li></ul><p></p><p><b> Team Collaboration & Support </b></p><ul><li> Work closely with cross-functional teams to meet project timelines and objectives. </li><li> Provide support and guidance to junior team members when required. </li><li> Foster a collaborative and knowledge-sharing environment. </li></ul><p></p><p><b> Qualifications </b></p><ul><li> Bachelor’s degree or higher in Life Sciences, Pharmacy, Medicine, Nursing, Biomedical Sciences, or a related field. </li></ul><p></p><p><b> Experience </b></p><ul><li>1–2 years of experience in a CRA, CTA, or Clinical Operations role within a CRO, pharmaceutical company, or consultancy. </li><li> Experience in observational studies (retrospective, prospective, cross-sectional, or real-world evidence studies). </li><li> Exposure to regulatory submissions and study start-up activities is highly desirable. </li></ul><p></p><p><b> Technical Skills </b></p><ul><li> Proficiency in Microsoft Office (Excel, Word). </li><li> Experience with Electronic Data Capture (EDC) systems (e.g., REDCap, Medidata Rave). </li><li> Familiarity with eTMF systems and document management platforms. </li><li> Strong knowledge of ICH-GCP guidelines and applicable regulations (including GDPR and Spanish regulatory framework). </li></ul><p></p><p><b> Competencies </b></p><ul><li> Strong organisational skills with high attention to detail. </li><li> Ability to manage multiple tasks and study sites simultaneously. </li><li> Excellent communication and interpersonal skills. </li><li> Proactive, problem-solving mindset with a customer-oriented approach. </li><li> Advanced level of English (written and spoken). </li><li> Native or near-native Spanish proficiency. </li></ul><p></p><p><b> Tu siguiente paso </b></p><p> Si estás interesado en esta oferta, haz click en "aplicar ahora" para enviar una copia actualizada de tu CV, o llámanos ahora. </p><p> Si esta oferta no se adapta a tu perfil pero estás buscando un nuevo puesto de trabajo, por favor contáctanos y lo comentamos. Te garantizamos la confidencialidad. </p>