Cra & cta - pharmaceutical consultancy (córdoba)

PbClinical Research Technical Associate (CRA / CTA) /b /ppbr/ppbPosition Overview /b /ppWe 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. /ppThe 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. /ppbr/ppbr/ppbKey Responsibilities /b /ppbr/ppbStudy Start-Up Regulatory Affairs /b /pulliPrepare, 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). /liliDraft, review, and track contracts, amendments, and informed consent forms. /liliCoordinate site initiation activities, including preparation of study start-up packages and Investigator Site Files (ISF). /liliLiaise with regulatory bodies to ensure timely approvals and ongoing compliance. /li /ulpbr/ppbDocument Management /b /pulliMaintain and organise Trial Master File (TMF) and Investigator Site Files (ISF) ensuring accurate filing, version control, and traceability. /liliManage electronic Trial Master File (eTMF) systems and perform periodic quality checks. /liliEnsure completeness of regulatory and study-specific documentation. /liliSupport document archiving at study close-out in line with retention policies. /li /ulpbr/ppbSite Monitoring Coordination /b /pulliMonitor study sites to ensure adherence to protocols, ICH-GCP guidelines, and local regulations. /liliConduct site initiation, monitoring, and close-out visits, including reporting and follow-up actions. /liliSupport participant screening via medical record review and coordination with healthcare professionals. /liliAct as a point of contact for site staff, sponsors, and vendors. /liliTrack enrolment and proactively manage recruitment or compliance issues. /li /ulpbr/ppbData Management /b /pulliReview and validate Case Report Forms (CRFs) ensuring consistency with source data. /liliAssist with data entry and resolution of queries in collaboration with data management teams. /liliEnsure timely and accurate data transfer and compliance with EDC systems. /liliSupport sites in meeting data quality and system requirements. /li /ulpbr/ppbCompliance Quality Assurance /b /pulliEnsure study activities comply with ICH-GCP, EU and Spanish regulations, and internal procedures. /liliSafeguard patient rights, safety, and wellbeing throughout study participation. /liliSupport audit and inspection readiness activities. /liliEnsure adherence to data protection regulations (GDPR). /li /ulpbr/ppbReporting Scientific Dissemination /b /pulliContribute to the preparation of clinical study reports and regulatory documentation. /liliSupport development of scientific publications, abstracts, and congress materials. /liliParticipate in feasibility assessments and proposal development. /li /ulpbr/ppbTeam Collaboration Support /b /pulliWork closely with cross-functional teams to meet project timelines and objectives. /liliProvide support and guidance to junior team members when required. /liliFoster a collaborative and knowledge-sharing environment. /li /ulpbr/ppbQualifications /b /pulliBachelor’s degree or higher in Life Sciences, Pharmacy, Medicine, Nursing, Biomedical Sciences, or a related field. /li /ulpbr/ppbExperience /b /pulli1–2 years of experience in a CRA, CTA, or Clinical Operations role within a CRO, pharmaceutical company, or consultancy. /liliExperience in observational studies (retrospective, prospective, cross-sectional, or real-world evidence studies). /liliExposure to regulatory submissions and study start-up activities is highly desirable. /li /ulpbr/ppbTechnical Skills /b /pulliProficiency in Microsoft Office (Excel, Word). /liliExperience with Electronic Data Capture (EDC) systems (e.g., REDCap, Medidata Rave). /liliFamiliarity with eTMF systems and document management platforms. /liliStrong knowledge of ICH-GCP guidelines and applicable regulations (including GDPR and Spanish regulatory framework). /li /ulpbr/ppbCompetencies /b /pulliStrong organisational skills with high attention to detail. /liliAbility to manage multiple tasks and study sites simultaneously. /liliExcellent communication and interpersonal skills. /liliProactive, problem-solving mindset with a customer-oriented approach. /liliAdvanced level of English (written and spoken). /liliNative or near-native Spanish proficiency. /li /ulpbr/ppbTu siguiente paso /b /ppSi estás interesado en esta oferta, haz click en \"aplicar ahora\" para enviar una copia actualizada de tu CV, o llámanos ahora. /ppSi esta oferta no se adapta a tu perfil pero estás buscando un actual puesto de trabajo, por favor contáctanos y lo comentamos. Te garantizamos la confidencialidad. /p