Senior Clinical Research Associate - FREELANCE - 0.2 - 0.4 FTE

ProPharma; España; Remote; EUR 12,000 - 28,000; Part time

Job summary

A leading pharmaceutical company is looking for a Freelance Senior Clinical Research Associate to work 0.2–0.4 FTE in Spain. The role involves managing existing study sites and setting up new ones, conducting monitoring visits, and ensuring compliance with local regulations. Candidates should possess excellent interpersonal and organizational skills, with over 5 years of experience in clinical research. A Bachelor's degree or equivalent is required. This contract position offers the flexibility to work remotely.

Qualifications

• More than 5 years of experience as a Clinical Research Associate.
• Experience managing multiple clinical sites successfully.
• Strong capability in documentation and regulatory compliance.

Responsibilities

• Manage existing and new clinical study sites.
• Conduct monitoring visits and write reports.
• Support study start-up activities and manage supplies.
• Perform study start-up activities: site identification, feasibility, essential documents collection, 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 and integrity, and resolve data issues.
• Monitor site enrollment, termination updates, protocol deviations, SAEs, lab abnormalities, and other trial conduct activities.
• Oversee regulatory documentation for accuracy and completeness; address regulatory concerns.

Skills

Excellent verbal and written communication

Interpersonal skills

Presentation skills

Proficiency in Microsoft Office

Experience with EDC, CTMS, IVRS, eTMF

Knowledge of local regulations, ICH Guidelines, GCP

Task prioritization

Organizational skills

Attention to detail

Education

Bachelor’s degree or equivalent

Job description

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.