GE is an equal opportunity employer, offering a great work environment, challenging career opportunities, professional training and competitive compensation.
The Clinical Research Associate (CRA) supports the Clinical Affairs Project Managers (CAPMs) and other team members as required through monitoring and coordinating of clinical research studies to ensure research is compliant with Good Clinical Practices and other applicable regulations and company procedures.
• Partners with CAPMs and project team members to perform initial contact with potential investigators and participates in the assessment and selection of qualified investigators for inclusion in research.
• Performs Qualification, Initiation, Monitoring, and Closeout site visits, or coordinate with contractors in their performance of these activities. Tracks required documentation from study site.
• Works with research site personnel to ensure all research activities are run compliantly and according to protocol.
• Perform comprehensive site management activities. Provide high-level consultative services to site personnel by coordinating and disseminating all pertinent data regarding study protocols, Case Report Forms, and GCP/applicable regulatory guidelines. Help to define quality standards within the project team.
• Reviews study documentation such as protocols, informed consents, amendments, case report forms and study reports.
• Reviews ethics committee reports.
• Ensures compliant recording and reporting of any adverse events occurring during research.
• Produce timely and comprehensive visit and status reports. Serve as Subject Matter Expert in the completion of thorough and accurate trip reports.
• Interfaces with Regulatory Agencies as required.
• Ensures overall regulatory compliance of investigational sites with applicable regulations.
• Reviews clinical history file for completeness throughout research process.
• May be involved with Research process improvement activities/projects as well as Corrective and/or Preventive actions tied to Research process.
• Depending on country/region location, assist with the collection of high quality documents required for study start and completion of ethics committee and regulatory submissions as applicable.
• Perform office-based project tasks as needed, including but not limited to: reviewing and evaluating regulatory/project documentation, contacting study site staff, providing project progress updates, developing tracking tools for deliverables, assisting other functional departments with project-specific tasks, etc.
Quality Specific Goals:
1. Aware of and comply with Good Clinical Practice guidelines, the GEHC Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/position
2. Complete all planned Quality & Compliance training within the defined deadlines
3. Identify and report any quality or compliance concerns and take immediate corrective action as required
4. Ensure Research is executed in compliance with Good Clinical Practices and other applicable regulations and company procedures.
5. Assist with continuous improvement activities by driving the implementation of process improvement initiatives
1. Bachelor’s degree (or internationally recognized equivalent) in a life sciences related field or R.N. with a minimum of 2 years experience with clinical research, OR minimum of 6 years progressive experience with clinical research.
2. Clinical Research experience such as: study site research coordination or management; sponsor-level clinical research project team experience. Other experience may include investigator qualifications; study monitoring; Clinical QA Auditing and/or Clinical Data Management within the pharmaceutical or medical device industry. (Medical Device research preferred.)
3. Ability to travel up to 70% of time for job related responsibilities.
Additional Eligibility Qualifications
GE will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a background investigation and drug screen.
1. Experience leading/supervising clinical research projects, including managing teams and the ability to prioritize, plan, delegate & evaluate deliverables; is well organized and structured, strong attention to detail.
2. Clinical trial professional certification, e.g. CCRP, CCRA or CCRN.
3. Experience interfacing with Regulatory Agencies such as FDA, European competent authorities & notified bodies, Health Canada, SFDA, KFDA, MHLW, etc.
4. Regulatory Affairs Certification (RAPS).
5. Knowledge of Quality Management Systems (QMS).
6. Experience working across cultures/countries/sites.
7. Demonstrated experience prioritizing conflicting demands from multiple business entities in an extremely fast paced environment.
8. Demonstrated ability to work well independently & in a team setting.
9. Strong problem solving, influencing and negotiation skills.
10. Excellent verbal and written communication and presentation skills with the ability to communicate business issues in English in an easy to understand manner.
11. Prior GEHC experience
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