Innovaderm Research Inc. — дерматологияға маманданған келісімшарттық зерттеу ұйымы (CRO). Компания I фазадан IV фазаға дейінгі клиникалық әзірлеу үдерістерін қолдайды. 2000 жылдан бері ол Солтүстік Америка мен Еуропадағы фармацевтикалық және денсаулық сақтау ұйымдарымен жұмыс істеп, дерматологиялық зерттеулер үшін зерттеу дизайны, реттеуші кеңес беру, жобаларды басқару, пациенттерді тарту және деректерді басқару қызметтерін ұсынады.
Freelance Clinical Research Associate – Dermatology and Rheumatology | Poland Hybrid
Contract Clinical Research Associate supporting dermatology and rheumatology trials for Indero, a global CRO. Responsibilities include site monitoring, source data verification, and regulatory compliance activities across Poland.
Сипаттама
- Track clinical study progress at investigative sites and through remote monitoring.
- Verify that trials are conducted, documented, and reported in line with protocols, SOPs, ICH-GCP, and applicable regulations.
- Carry out site qualification, initiation, monitoring, and close-out visits in accordance with monitoring plans and relevant standards.
- Attend investigator meetings.
- Draft site visit reports and follow-up correspondence for investigators.
- Develop effective working relationships with investigators and site personnel to support study objectives and patient recruitment goals.
- Conduct source data verification.
- Confirm appropriate on-site storage, dispensing, and accountability of study medication.
- Maintain complete data collection and regulatory documentation.
- Take on other duties for which you are qualified or appropriately trained.
- Complete a recruitment process that includes interviews with Indero team members.
Талаптар
- Bachelor of Science in a clinically relevant field, a nursing degree, or equivalent experience.
- Three years of experience conducting on-site clinical monitoring in biotechnology, pharmaceutical, or contract research organization environments.
- At least one year of dermatology experience.
- Working knowledge of ICH-GCP standards and applicable regulatory requirements.
- Strong spoken and written English communication skills.
- Ability to manage competing assignments, work under pressure, maintain accuracy, and meet deadlines.
- Sound judgment and strong problem-solving ability.
- Willingness to travel to research sites approximately 65% of the time.
- Advanced proficiency with Microsoft Office, including Word, Excel, and PowerPoint.
- Legal authorization to work in Poland.
Артықшылықтар
- Stimulating professional environment.
- Opportunities for career advancement.
- Upon request, accommodations during recruitment and selection are available for applicants with disabilities.