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In House Clinical Research Associate
3 months ago
Job Description Summary:
To provide in-house support relating to study set-up, monitoring and close-out activities to ensure the compliant and efficient conduct of GE HealthCare clinical studies.
This role is unique compared to typical CRA roles since it only requires very limited travel
Our Pharmaceutical Diagnostics (PDx) business is the number one global supplier of contrast media and molecular imaging agents used to enhance medical imaging exams.
Used throughout all major disease area diagnostic and treatment pathways, PDx products support three patients every second around the world.
Essential Responsibilities:
- (Perform initial contact and participate in the assessment and selection of qualified investigators for inclusion in clinical programs.
- Serve as the primary inhouse contact for sites and investigators participating in studies.
- Work with onsite monitors, to ensure compliant and efficient study conduct at site.
- Support the conduct of Pre-Selection, Initiation, Monitoring, and Closeout site visits. Attending (comonitoring) as required (mínimal travel expected for this in house role).
- Provide input to the preparation of study documentation such as protocols, amendments, Case Report Forms, and study reports.
- Facilitate and support the preparation of regulatory and IEC/IRB submissions
- Facilitate the collection and processing (upload to eTMF) of essential documents and correspondence.
- Ensure that the files for the site (TMF and working files) for which the job holder is responsible are up to date, accurate and include all essential documents as detailed in ICH-GCP.
- Assist in the conduct of internal and external Trial Master File Audits, in accordance with applicable SOPs and regulations/guidelines.
- Negotiate and track site/trial budget according to financial agreement with each site and facilitation of site contract execution.
- Develop and/or review Patient information and Informed Consent Forms and other patient facing materials as required.
- Ensure that clinical sites have adequate supplies (IMP and Non-IMP) to perform the study.
- Actively attend study team meetings, including followup on assigned action items.
- Develop a thorough knowledge of the diagnostic/therapeutic filed and clinical programme(s) for the studiy(s) to which the job holder is assigned.
- Support oversight of vendor(s), e.g. Central Laboratory, as needed.
- Participate in the development and review of Standard Operating Procedures, guidelines, forms and checklists.
- Assist in the coordination of investigator meetings.
- Perform training to site personnel, vendor and internal study personnel, as required.
- Actively identify and communicate areas for improvement within the global clinical research infrastructure at GE HealthCare.
Qualifications/Requirements*:
- Bachelors in a scientific/medical discipline with at least 3 years Clinical Research or equivalent experience.
Desired qualifications:
- Masters degree or PhD
- Monitoring experience
Inclusion and Diversity:
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 expression, age, disability, protected veteran status or other characteristics protected by law.
Behaviours:
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.
Total Rewards:
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.
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Additional Information:
Relocation Assistance Provided:
No
