Descripción de la oferta
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 degree or equivalent combination of education and experience.
Experience
More than 5 years as a Clinical Research Associate.
Employment Type
Contract.
Location
Spain.
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