Business Segment: Healthcare Technology & Medical Innovation
Location(s): United States; Wisconsin; Waukesha
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. GE offers a great work environment, professional development, challenging careers, and competitive compensation. GE is an Equal Opportunity Employer. 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.
Role Summary: The Project Coordinator supports the Clinical Affairs Project Manager (CAPM) in planning and co-ordination activities around the conduct of clinical trials, including all operational aspects of a clinical project. support the CAM and the cross-functional study team in the successful execution of assigned clinical trials from protocol concept through to clinical study report, in compliance with international GCP guidelines/regulations and GEHC policies and procedures.
Essential Responsibilities: •Collaborates closely with CAPM’s and Clinical Research Associates, cross-functional study teams and all Research partners, internal and external to GEHC •Supports the implementation and management of clinical research studies through file management and clinical project document control. At times may be asked to interact with clinical sites and will do so regularly over time •Assists the clinical project teams in project related activities, such as creating study binders, shipping study documents •Coordinates and participates in study team meetings and drafts meeting minutes and agendas •Reviews and tracks clinical trial site-related required documentation, regulatory documents and internal GEHC documents •Uploads and maintains study documents in tracking databases in a timely manner •Maintains study tracking tools, metrics, and study calendars •Assists in the planning and preparation for investigator meetings and monitoring visits •Coordinate travel arrangements, when necessary •Provide administrative support to the Clinical Affairs team as required •Some travel may be required
Qualifications/Requirements: 1. Associates degree (or internationally recognized equivalent.) 2. Minimum of one year’s administrative support experience. 3. Proficient in E-mail, Word, Excel, PowerPoint and Windows applications.
Desired Characteristics: 1.Bachelor’s degree (or internationally recognized equivalent) in a life sciences related field or R.N. 2.Advanced capabilities in E-mail, Word, Excel, PowerPoint and Windows applications. 3.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.) 4.Project management experience including the ability to prioritize, plan & evaluate deliverables; is well organized and structured, strong attention to detail. 5.Experience working across cultures/countries/sites. 6.Demonstrated experience prioritizing conflicting demands from multiple business entities in an extremely fast paced environment. 7.Demonstrated ability to work well independently & in a team setting. 8.Strong problem solving, influencing and negotiation skills. 9.Excellent verbal and written communication and presentation skills with the ability to communicate business issues in English in an easy to understand manner. 10.Prior GEHC experience
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