12 Π΄Π½Π΅ΠΉ Π½Π°Π·Π°Π΄
Sr. CRA 3 (Clinical Research)
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
Sr. CRA 3 (Clinical Research): Managing and monitoring clinical trial sites in Brazil across qualification, initiation, routine monitoring, and closeout visits with an accent on GCP, ICH, regulatory compliance, and site performance. Focus on reviewing source documentation, resolving data queries, supporting patient recruitment and retention, and addressing quality issues across multiple study phases.
Location: SΓ£o Paulo, Brazil
Company
IQVIA Biotech is a full-service clinical research organization serving biotech sponsors with therapeutically aligned clinical development solutions.
What you will do
- Independently manage and monitor clinical trial sites across multiple research phases.
- Conduct site qualification, initiation, routine monitoring, and closeout visits.
- Support patient recruitment and retention, and provide protocol and study-related training.
- Review source documentation, oversee site performance, track study milestones, and resolve data queries.
- Maintain regulatory and essential documents and prepare timely, accurate monitoring reports.
- Collaborate with cross-functional study teams and mentor junior CRAs through co-monitoring and training.
Requirements
- Bachelorβs degree in a scientific, healthcare, or related discipline, or equivalent education and experience.
- At least 4 years of on-site clinical monitoring experience.
- Strong knowledge of GCP, ICH guidelines, FDA regulations, and clinical trial processes.
- Experience conducting monitoring visits across multiple phases of clinical research.
- Strong organizational, communication, and problem-solving skills with the ability to manage multiple priorities.
- Proficiency with Microsoft Office applications and clinical trial systems.
Nice to have
- Strong therapeutic area knowledge and protocol management experience.
- Experience building relationships with investigative sites, sponsors, and internal study teams.
- Experience mentoring or supporting junior clinical research professionals.
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