Clinical Research Associate
3 weeks ago
Job Description Summary
The Clinical Research Associate (CRA) will be responsible for the setup, monitoring, and management of clinical trials. This role involves ensuring compliance with regulatory requirements, maintaining study documentation, and collaborating with study sites to ensure the successful execution of GE HealthCare clinical studies. This role is to support a clinical study in Karolinska, Sweden, with expected duration of 18 months.
GE HealthCare is a leading global medical technology and digital solutions innovator with over 100 years of healthcare industry experience and around 50,000 employees globally. We enable clinicians to make faster, more informed decisions through intelligent devices, data analytics, applications and services, supported by our Edison intelligence platform. We operate at the center of an ecosystem working toward precision health - digitizing healthcare, helping drive productivity and improving outcomes for patients, providers, health systems and researchers around the world.
Job Description
Main areas of responsibility & tasks
- Study Setup:
- Assist in the development and review of study protocols, informed consent forms, and other essential documents, including EDC.
- Coordinate with study sites to ensure proper site selection, initiation, and training.
- Assist in the development of study specific plans.
- Prepare and distribute study materials, including investigator brochures, case report forms, and study manuals.
- Support CTIS Submission and associated document creation.
- Assist site with CTIS Submission activities.
- Ensure all regulatory and ethical approvals are obtained before study initiation.
- Negotiate and track site/trial budget according to financial agreement with each site and facilitation of site contract execution.
- Review study systems prior to site initiation.
- Monitoring:
- Perform training to site personnel, vendor and internal study personnel, as required.
- Conduct regular site visits to monitor study progress, ensure protocol adherence, and verify data accuracy.
- Perform source data verification (SDV) to ensure data integrity and compliance with Good Clinical Practice (GCP) guidelines.
- Identify and resolve any issues or discrepancies at study sites, providing guidance and support to site staff.
- Maintain accurate and up-to-date study documentation, including monitoring visit reports, correspondence, and regulatory files.
- Facilitate the collection and processing (upload to eTMF) of essential documents and correspondence.
- Ensure that clinical sites have adequate supplies (IMP and Non-IMP) to perform the study.
- CTIS Submission:
- Prepare and submit clinical trial applications and related documents to the Clinical Trials Information System (CTIS).
- Ensure all submissions comply with regulatory requirements and timelines.
- Monitor the status of submissions and address any queries or requests from regulatory authorities.
- Communication and Collaboration:
- Serve as the primary point of contact for study sites, providing ongoing support and addressing any queries or concerns.
- Collaborate with cross-functional teams, including project managers, data managers, and regulatory affairs, to ensure smooth study execution.
- Participate in investigator meetings, site initiation visits, and other study-related meetings as required.
- Compliance and Quality Assurance:
- Ensure all study activities are conducted in accordance with applicable regulations, guidelines, and company SOPs.
- Assist in the preparation and conduct of audits and inspections by regulatory authorities.
- Contribute to continuous improvement initiatives to enhance study processes and quality.
Personal Specification / Desirable Qualifications
- PhD, MSc or BSc in a scientific / medical discipline with at least 3 years Clinical Research including monitoring.
- Communication in local language with the sites.
Skills/Attributes
Thorough understanding of the processes that are part of the day-to-day work of Clinical Research. Strong knowledge of GCP, ICH guidelines, and regulatory requirements. Experience with CTIS submissions is highly desirable. Demonstrable teamwork, communication, interpersonal, and problem-solving skills. A good understanding of the relevant Health Authority regulations, guidance and the drug development process. The ability to manage multiple priorities and work well under pressure and time constraints. Strong process improvement mindset, passion for quality. Technical aptitude (i.e. able to read and comprehend technical documentation, ability to comprehend and execute procedures, demonstrated understanding of system documentation). Strong organizational skills with high attention to detail. Familiarity with industry standard computerized system applications.
Experience With Veeva Or Other Document/information Management Systems Desired
Why Join Us?
At GE Healthcare, you'll drive innovation in RF and power electronics, contributing to medical technologies with a global impact. Join a supportive team where your skills make a difference.
Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you'd expect from an organization with global strength and scale, and you'll be surrounded by career opportunities in a culture that fosters care, collaboration and support.
We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership – always with unyielding integrity.
GE HealthCare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or, age, disability, protected veteran status or other characteristics protected by law.
Additional Information
Relocation Assistance Provided: No
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