12 дней назад
Experienced CRA - Single Sponsor Dedicated
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Experienced CRA - Single Sponsor Dedicated (Clinical Research): Conducting site monitoring and managing clinical trial execution across investigative sites with an accent on GCP/ICH compliance, recruitment tracking, and study documentation. Focus on evaluating site quality, resolving data queries, maintaining TMF and ISF records, and coordinating regulatory and study-team activities.
Location: Reading, Berkshire, United Kingdom; regular travel to clinical trial sites required
Company
Global provider of 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 according to contracted scope, GCP, and ICH requirements.
- Support site recruitment plans, protocol training, ongoing communication, and project expectation management.
- Evaluate site practices, protocol compliance, and data quality, escalating issues when necessary.
- Track regulatory submissions, approvals, recruitment, enrollment, CRF completion, and data-query resolution.
- Maintain TMF documentation and verify that Investigator Site Files are complete and compliant.
- Prepare monitoring visit reports, follow-up letters, action plans, and other study documentation while collaborating with the study team.
Requirements
- At least six months of independent on-site monitoring experience.
- Experience managing multiple clinical trial protocols across diverse investigative sites.
- In-depth knowledge of Good Clinical Practice and International Conference on Harmonization guidelines.
- Degree in life sciences or equivalent industry experience.
- Flexibility to travel to clinical sites.
- UK visa sponsorship is not available for this role.
Culture & Benefits
- Career development opportunities within a global clinical research organization.
- Exposure to cutting-edge medicines and new medicines development.
- Access to significant data pools supporting site selection and recruitment performance.
- Work focused on improving patient outcomes and population health.
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