12 дней назад
Clinical Research Associate 1 or 2 (M/W/D), Single Sponsor
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Clinical Research Associate 1 or 2 (M/W/D), Single Sponsor (Clinical Research): Conducting site selection, initiation, monitoring, and close-out visits for clinical studies across Germany with an accent on GCP/ICH compliance, recruitment planning, and regulatory tracking. Focus on evaluating site quality, resolving data queries, coordinating with study sites and sponsors, and supporting remote monitoring and study start-up activities.
Location: Home-based throughout Germany; the role requires travel for up to 40–60% of working time.
Company
provides clinical research services, commercial insights, and healthcare intelligence for the life sciences and healthcare industries.
What you will do
- Perform site selection, initiation, monitoring, and close-out visits.
- Support subject recruitment planning and track recruitment progress.
- Evaluate site quality and data integrity against regulatory requirements, GCP, and ICH guidelines.
- Track regulatory submissions, case report form completion, and data query resolution.
- Collaborate with study-site experts and client representatives.
- Support remote monitoring, study start-up, therapeutic-area specialization, and mentoring depending on the client model.
Requirements
- University degree in life science or another scientific discipline, or healthcare apprenticeship.
- At least 12 months of on-site monitoring experience.
- Knowledge of clinical research regulations, GCP, and ICH guidelines.
- Strong written and verbal communication skills, attention to detail, and the ability to work in a fast-paced environment.
- Fluency in German at C1 level or higher and a good command of English.
- Class B driver’s license and flexibility to travel up to 40–60% of working time.
Culture & Benefits
- Permanent employment contract.
- Home-office arrangement and flexible working schedules.
- Competitive salary, company car or car allowance, accident insurance, and pension benefits.
- Training, mentoring, and resources supporting career development.
- Exposure to different therapeutic areas and dynamic clinical research environments.
Hiring process
- Submit an English CV, motivation letter, education certificates, and employment reference letters.
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