Clinical Research Associate

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well‑being of people around the world. We are leaders in plasma‑derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.

The Clinical Research Associate assists in the management of the clinical monitoring process to ensure site adherence to applicable regulatory requirements, ICH/GCP Guidelines, company SOPs, and study protocols. Ensures coordination of an accelerated study start‑up including pre‑study visits, initiation, interim, and closeout activities associated with clinical trials to ensure timelines and metrics are met and maintained throughout the study.

• Tracking study specific tasks and progress of the trial.
• Performing regulatory document review and approval for IP release.
• Assisting in the coordination and planning of meetings (e.g. Investigator Meetings, Kick‑off meetings).
• Conducting monitor training.
• Performing monitoring/co‑monitoring activities for site initiation visits, interim site monitoring, and closeout visits, in conformance to all relevant laws, regulations, guidelines and internal SOPs/policies.
• Understanding and implementing processes for distribution and tracking of SAE's, safety documentation, and pregnancies. Monitors compliance of these processes.
• Collaborating with data management to resolve queries.
• Facilitating investigator site payments, as applicable.
• Reviews/creates/tracks trial newsletters, memos, mass correspondence, or other appropriate trial‑related documentation.
• Assisting in evaluation of vendor performance during conduct of the study.
• Acquiring a basic knowledge of the therapeutic area and product.
• Obtaining a complete understanding of all trial‑related documents and operational procedures.
• Gaining exposure/participates in CRF development, IVRS set‑up, central lab set‑up, and other vendor selection processes.
• Maintaining clinical trial management system (CTMS) information pertaining to the study as applicable.
• Assisting with auditing of study files and retrieval of outstanding documents as needed (in‑house and on‑site document reconciliation).
• Reviewing and tracking study documents, including: project files both electronically and in the Trial Master File and Project Status Reports.
• Preparing accurate and complete meeting minutes for various meetings.
• Communicating and interacting with relevant study personnel, including: develops and maintains collaborative relationships to manage study issues and support milestone achievement; conveys project information; answers study questions in a timely manner while using discretion when to elevate to study manager; troubleshoots and follows up on study progress; and, reviews report data for completeness and accuracy.
• Assists with effective and timely audit/inspection responses.

• Identifies/screens/qualifies investigators through feasibility questionnaires and pre‑study visits.
• Assists with expedited identification, retrieval, and review of study documents particularly those required for site activation/study start‑up.
• Conducts/oversees completion of Pre‑Study Visits, Site Initiation Visits, Interim Monitoring Visits, and Close‑Out Visits, to determine protocol and regulatory compliance.
• Verifies study documents (e.g., case report forms, source documents, adverse events) are tracked and reviewed for completeness and accuracy to ensure data integrity.
• Reconciles clinical supplies and drug accountability records at study sites.
• Identifies and effectively documents site findings with an equal ability to re‑train, place corrective action in place with the site, and follow‑up as required.
• Reviews, clarifies, and obtains, data changes via query resolutions with site personnel.
• Prepares telephone contact reports, confirmation letters, site visit reports (PSV, SIV, IMV, and COV), and…