9 дней назад
Snr CRA (Oncology)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Snr CRA (Oncology) (Clinical Research): Monitoring and managing oncology clinical trial sites to ensure protocol compliance, reliable study data, and regulatory adherence with an accent on GCP, ICH guidelines, recruitment tracking, and site documentation. Focus on conducting monitoring visits, resolving quality and data issues, maintaining TMF and ISF records, and mentoring clinical staff.
Location: Stockholm, Sweden
Company
provides clinical research services, commercial insights, and healthcare intelligence for the life sciences and healthcare industries.
What you will do
- Conduct site selection, initiation, monitoring, and close-out visits for oncology trials.
- Track recruitment, enrollment, regulatory submissions, CRF completion, and data query resolution.
- Train assigned sites on study protocols and maintain communication about project expectations and issues.
- Evaluate site quality, protocol compliance, and adherence to GCP, ICH, and local regulatory requirements.
- Maintain monitoring reports, follow-up letters, action plans, TMF documentation, and ISF compliance.
- Mentor clinical staff and collaborate with study team members on project execution.
Requirements
- Bachelor’s degree in a scientific or healthcare discipline, or equivalent education, training, and experience.
- At least 4 years of on-site monitoring experience.
- In-depth knowledge of GCP, ICH guidelines, and applicable clinical research regulations.
- Strong therapeutic and protocol knowledge, organizational, problem-solving, time-management, and financial-management skills.
- Good command of English and strong written and verbal communication skills.
- Proficiency with Microsoft Word, Excel, PowerPoint, laptops, and mobile devices.
Culture & Benefits
- Work as part of a multi-sponsor clinical research team.
- Collaborate with coworkers, managers, clients, sites, and study team members.
- Support clinical staff development through co-monitoring and training visits.
- Employment is full time.
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