Innovaderm Research Inc. este o organizație de cercetare contractuală (CRO) axată pe dermatologie, care sprijină dezvoltarea clinică din faza I până în faza IV. Din 2000, compania colaborează cu organizații farmaceutice și din domeniul sănătății din America de Nord și Europa, oferind servicii de proiectare a studiilor, consultanță de reglementare, management de proiect, recrutarea pacienților și gestionarea datelor pentru cercetarea dermatologică.
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.
Descriere
- 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.
Cerințe
- 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.
Beneficii
- Stimulating professional environment.
- Opportunities for career advancement.
- Upon request, accommodations during recruitment and selection are available for applicants with disabilities.