Clinical Research Associate

Job description

3059072
City

Beijing
Career Level

Experienced
Relocation Assistance

No
Business

GE Healthcare
Business Segment

Healthcare Technology & Medical Innovation
Function

Engineering/Technology
Country/Territory

China
U.S. State, China or Canada Provinces

BeiJing
Postal Code

100176
Essential Responsibilities

• 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 source documents, study images, 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 creation of and/or 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.
Qualifications/Requirements

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. Good collaborative oral and written communication skills, with ability to relay pertinent information to site personnel and study teams.
4. Strong team skills with ability to work effectively with GEHC and research site personnel.
5. Ability to travel up to 70% of time for job related responsibilities.
6. Computer literate; Proficient Microsoft Office skills including Word, Excel, and Outlook. Ability to adapt to multiple technology platforms/systems.
About Us

GE is the world's Digital Industrial Company, transforming industry with software-defined machines and solutions that are connected, responsive and predictive. Through our people, leadership development, services, technology and scale, GE delivers better outcomes for global customers by speaking the language of industry.