Senior Clinical Research Associate
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- 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. #J-18808-Ljbffr
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