In House Clinical Research Associate (CRA)

Job Description Summary
This role is to provide in house (limited travel) support relating to study set-up, monitoring and close-out activities to ensure the compliant and efficient conduct of GE HealthCare clinical studies.

GE HealthCare is a leading global medical technology and digital solutions innovator. Our mission is to improve lives in the moments that matter. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world.

Job Description

Responsibilities

• Perform initial contact and participate in the assessment and selection of qualified investigators for inclusion in clinical programs.
• Serve as the primary in-house contact for sites and investigators participating in studies.
• Work with on-site monitors, to ensure compliant and efficient study conduct at site.
• Support the conduct of Pre-Selection (feasibility), Initiation, Monitoring, and Closeout site visits. Attending (co-monitoring) as required (minimal travel expected for this in house role).
• Support with reviews of monitoring visit reports as required.
• 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.
• Assist with the tracking of subject enrollment at each trial site, and provide management with detailed reports of clinical activities, as requested.
• Ensure that clinical sites have adequate supplies (IMP and Non-IMP) to perform the study.
• Actively attend study team meetings, including follow-up on assigned action items.
• Develop a thorough knowledge of the diagnostic/therapeutic field and clinical programme(s) for the studie(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

• PhD, MSc or BSc in a scientific / medical discipline with at least 3 years Clinical Research (preferably monitoring) or equivalent experience
• Thorough understanding of the processes that are part of the day-to-day work of Clinical Research
• Demonstrable team-work, communication, interpersonal, and problem-solving skills
• A good understanding of the relevant Regulatory 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 computerised system applications (e.g. eTMF, EDC, CTMS)
• Experience with Veeva or other document/information management systems desired
• Ability to work independently

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 #J-18808-Ljbffr