Senior Clinical Research Associate (España)

Senior Clinical Research Associate (España)

30 jul
|
Propharma
|
España

30 jul

Propharma

España

Senior Clinical Research Associate - FREELANCE - 0.2 - 0.4 FTE
Join ProPharma as a Freelance Senior Clinical Research Associate (SCAR) working 0.2–0.4 FTE in Spain.
Responsibilities
- Manage one existing site and set up/monitor three new sites for a study.
- Conduct all types of monitoring: site initiation, interim, close‑out, co‑monitoring visits both in person and remote.
- Write and complete monitoring reports within SOP and local regulatory parameters.
- Perform study start‑up activities: site identification, feasibility, collection of essential documents, Ethics Committee submissions, and other site setup activities.
- Support development of study‑specific monitoring documentation (trackers, guidelines, plans, templates, tools).
- Review source documents and case report forms for accuracy, completeness and integrity, and resolve data issues.
- Manage investigational supplies: preparation, dispatch, return, inventory, and reconciliation.
- Monitor site enrollment, termination updates, protocol deviations, serious adverse events, lab abnormalities,



and other activities contributing to trial conduct.
- Oversee regulatory documentation for accuracy and completeness; address regulatory concerns.
- Communicate with sites, investigators, client personnel and cross‑functional teams regarding monitoring and site‑management needs.
- Participate in meetings and conference calls with internal teams, sponsor teams, and external partners.
- Other duties as assigned.

Required Qualifications
- Excellent verbal, written, interpersonal and presentation skills.
- Proficient in Microsoft Office (Outlook, Word, Excel, PowerPoint).
- Experience with EDC, CTMS, IVRS, and eTMF.
- Knowledge of local regulations, ICH Guidelines, and GCP.
- Ability to prioritize tasks, plan proactively, and accomplish goals with minimal supervision.
- Capable of providing solutions when obstacles arise and training as needed.
- Strong organizational skills and attention to detail.

Education
Bachelor’s

📌 Senior Clinical Research Associate (España)
🏢 Propharma
📍 España

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