• 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.

• 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.

• 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.

• 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.

• 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).

• 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.

• 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.

• Bachelor’s degree or higher in Life Sciences, Pharmacy, Medicine, Nursing, Biomedical Sciences, or a related field.

• 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.

• 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).

• 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.

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