4 дня назад
Clinical Research Associate II / SCRA (Clinical Trials)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Clinical Research Associate II / SCRA (Clinical Trials): Conducting remote and onsite monitoring visits for clinical studies, maintaining trial documentation, and ensuring data integrity and patient safety with an accent on ICH GCP, ISO 14155, site communication, and monitoring quality. Focus on planning qualification, initiation, interim, and close-out visits, resolving site queries, maintaining TMF/eTMF records, and addressing trial issues across fast-paced projects.
Location: United Kingdom; travel required 70–85%, including onsite investigator-site visits.
Company
supports biotech, medtech, and specialty pharma companies in developing medicines, medical devices, and diagnostics.
What you will do
- Conduct qualification, study initiation, interim monitoring, close-out, and other required visits using remote, onsite, or approved monitoring methods.
- Review clinical data, source documentation, investigational product accountability, and site records to protect patient safety and data integrity.
- Prepare timely monitoring reports, maintain TMF/eTMF documentation, and manage site query resolution with Data Management.
- Plan site-monitoring activities, track subjects and sites, manage priorities, and escalate quality, timeline, scope, and budget issues.
- Collaborate with Clinical Leads, Project Managers, study teams, investigators, and sites; coach other CRAs and share best practices.
- Support feasibility, recruitment, investigator meetings, training, and additional country- or project-specific responsibilities when assigned.
Requirements
- Degree or equivalent work experience in a clinical, science, or health-related field; licensed healthcare professionals may also qualify.
- At least 2 years of clinical-trial experience, previous successful CRA experience, and completion of a CRA training program.
- Fluent English and fluency in the host-country language are required.
- Knowledge of ICH GCP, ISO 14155, relevant FDA, EU, and local regulations, clinical monitoring procedures, and drug or device development.
- Experience coaching or mentoring CRAs, strong communication and organizational skills, and the ability to manage changing priorities.
- Ability to travel 70–85%, lift up to 25 lbs, and hold a valid driver’s license and passport as required.
Culture & Benefits
- Flexible working practices designed to support professional growth and work-life balance.
- Collaborative environment where team members contribute ideas and influence ways of working.
- Access to internal and study-specific training to expand therapeutic and clinical expertise.
- Work on medical innovation intended to improve patient outcomes.
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