CRA & CTA - Pharmaceutical Consultancy

Location: Cequelinos

Clinical Research & Technical Associate (CRA / CTA)

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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.

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