Senior Clinical Research Associate

Hace 3 días

España ProPharma Trabajo remoto Jornada completa 12.000 € - 28.000 €/año

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.