CRA & CTA - Pharmaceutical Consultancy - tarragona
hace 10 días
Tarragona
Clinical Research & Technical Associate (CRA / CTA) Position Overview 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. 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. Key Responsibilities Study Start-Up & Regulatory Affairs • 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)., • Draft, review, and track contracts, amendments, and informed consent forms., • Coordinate site initiation activities, including preparation of study start-up packages and Investigator Site Files (ISF)., • Liaise with regulatory bodies to ensure timely approvals and ongoing compliance. Document Management • Maintain and organise Trial Master File (TMF) and Investigator Site Files (ISF) ensuring accurate filing, version control, and traceability., • Manage electronic Trial Master File (eTMF) systems and perform periodic quality checks., • Ensure completeness of regulatory and study-specific documentation., • Support document archiving at study close-out in line with retention policies. Site Monitoring & Coordination • Monitor study sites to ensure adherence to protocols, ICH-GCP guidelines, and local regulations., • Conduct site initiation, monitoring, and close-out visits, including reporting and follow-up actions., • Support participant screening via medical record review and coordination with healthcare professionals., • Act as a point of contact for site staff, sponsors, and vendors., • Track enrolment and proactively manage recruitment or compliance issues. Data Management • Review and validate Case Report Forms (CRFs) ensuring consistency with source data., • Assist with data entry and resolution of queries in collaboration with data management teams., • Ensure timely and accurate data transfer and compliance with EDC systems., • Support sites in meeting data quality and system requirements. Compliance & Quality Assurance • Ensure study activities comply with ICH-GCP, EU and Spanish regulations, and internal procedures., • Safeguard patient rights, safety, and wellbeing throughout study participation., • Support audit and inspection readiness activities., • Ensure adherence to data protection regulations (GDPR). Reporting & Scientific Dissemination • Contribute to the preparation of clinical study reports and regulatory documentation., • Support development of scientific publications, abstracts, and congress materials., • Participate in feasibility assessments and proposal development. Team Collaboration & Support • Work closely with cross-functional teams to meet project timelines and objectives., • Provide support and guidance to junior team members when required., • Foster a collaborative and knowledge-sharing environment. Qualifications • Bachelor’s degree or higher in Life Sciences, Pharmacy, Medicine, Nursing, Biomedical Sciences, or a related field. Experience • 1–2 years of experience in a CRA, CTA, or Clinical Operations role within a CRO, pharmaceutical company, or consultancy., • Experience in observational studies (retrospective, prospective, cross-sectional, or real-world evidence studies)., • Exposure to regulatory submissions and study start-up activities is highly desirable. Technical Skills • Proficiency in Microsoft Office (Excel, Word)., • Experience with Electronic Data Capture (EDC) systems (e.g., REDCap, Medidata Rave)., • Familiarity with eTMF systems and document management platforms., • Strong knowledge of ICH-GCP guidelines and applicable regulations (including GDPR and Spanish regulatory framework). Competencies • Strong organisational skills with high attention to detail., • Ability to manage multiple tasks and study sites simultaneously., • Excellent communication and interpersonal skills., • Proactive, problem-solving mindset with a customer-oriented approach., • Advanced level of English (written and spoken)., • Native or near-native Spanish proficiency. Tu siguiente paso Si estás interesado en esta oferta, haz click en "aplicar ahora" para enviar una copia actualizada de tu CV, o llámanos ahora. 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.
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