2 Π΄Π½Ρ Π½Π°Π·Π°Π΄
Senior Clinical Research Associate (Dermatology)
ΠΡΡΡ & Π‘ΠΎΠΏΡΠΎΠ²ΠΎΠ΄
ΠΠ»Ρ ΠΌΡΡΡΠ° Ρ ΡΡΠΎΠΉ Π²Π°ΠΊΠ°Π½ΡΠΈΠ΅ΠΉ Π½ΡΠΆΠ΅Π½ Plus
ΠΠΏΠΈΡΠ°Π½ΠΈΠ΅ Π²Π°ΠΊΠ°Π½ΡΠΈΠΈ
Π’Π΅ΠΊΡΡ:
TL;DR
Senior Clinical Research Associate (Dermatology): Monitoring clinical trials across investigator sites in Spain, preparing monitoring reports, maintaining trial master files, and verifying site documentation with an accent on data integrity, patient safety, and dermatology studies. Focus on planning and conducting qualification, initiation, interim monitoring, and close-out visits across clinical trial phases IβIV, with country-wide monitoring averaging six onsite days per month.
Location: Spain; the role can be fully remote, hybrid, or office based, with country-wide monitoring and an average of 6 onsite days per month.
Company
supports biotech, medtech, and specialty pharma companies in developing medicines, medical devices, and diagnostics.
What you will do
- Conduct remote, onsite, and other approved monitoring activities in line with clinical monitoring plans, country regulations, data integrity, and patient safety requirements.
- Prepare for and conduct site qualification, study initiation, interim monitoring, and close-out visits at investigator sites.
- Deliver accurate and timely monitoring reports for sponsor approval.
- Plan daily monitoring activities, set site priorities, and manage related expenses according to company guidelines.
- Maintain the Trial Master File and electronic Trial Master File in accordance with filing processes and ICH/GCP Section 8 requirements.
- Review site documents to ensure they are accurate, complete, current, and properly updated.
Requirements
- Undergraduate degree or international equivalent in a clinical, science, or health-related field, a licensed healthcare qualification such as registered nursing, or equivalent work experience.
- Previous clinical research experience and at least 4 years of experience in clinical trials and independent monitoring.
- Essential experience in dermatology.
- Experience across clinical trial phases IβIV is preferred; candidates with phase II and III experience will also be considered.
- Country-wide monitoring in Spain is required, averaging 6 onsite days per month.
Culture & Benefits
- Flexible choice of fully remote, hybrid, or office-based work.
- Support for professional growth through skills development and career opportunities.
- Emphasis on work-life balance and flexibility.
- Opportunities to contribute ideas and influence ways of working.
ΠΡΠ΄ΡΡΠ΅ ΠΎΡΡΠΎΡΠΎΠΆΠ½Ρ: Π΅ΡΠ»ΠΈ ΡΠ°Π±ΠΎΡΠΎΠ΄Π°ΡΠ΅Π»Ρ ΠΏΡΠΎΡΠΈΡ Π²ΠΎΠΉΡΠΈ Π² ΠΈΡ ΡΠΈΡΡΠ΅ΠΌΡ, ΠΈΡΠΏΠΎΠ»ΡΠ·ΡΡ iCloud/Google, ΠΏΡΠΈΡΠ»Π°ΡΡ ΠΊΠΎΠ΄/ΠΏΠ°ΡΠΎΠ»Ρ, Π·Π°ΠΏΡΡΡΠΈΡΡ ΠΊΠΎΠ΄/ΠΠ, Π½Π΅ Π΄Π΅Π»Π°ΠΉΡΠ΅ ΡΡΠΎΠ³ΠΎ - ΡΡΠΎ ΠΌΠΎΡΠ΅Π½Π½ΠΈΠΊΠΈ. ΠΠ±ΡΠ·Π°ΡΠ΅Π»ΡΠ½ΠΎ ΠΆΠΌΠΈΡΠ΅ "ΠΠΎΠΆΠ°Π»ΠΎΠ²Π°ΡΡΡΡ" ΠΈΠ»ΠΈ ΠΏΠΈΡΠΈΡΠ΅ Π² ΠΏΠΎΠ΄Π΄Π΅ΡΠΆΠΊΡ. ΠΠΎΠ΄ΡΠΎΠ±Π½Π΅Π΅ Π² Π³Π°ΠΉΠ΄Π΅ β