R&D/PRODUCT DVL ENGINEER II
Location: #, CA, US, _
Job Type: Full time
At TE, you will unleash your potential working with people from diverse backgrounds and industries to create a safer, sustainable and more connected world.
The Clinical Research Associate II (CRA) will monitor the progress of clinical studies at investigative sites or remotely, and ensure clinical trials are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), ICH/GCP, and all applicable regulatory requirements.
- Implement and monitor clinical trials to ensure sponsor and investigator obligations are being met and are compliant with applicable local regulatory requirements and ICH/GCP guidelines
- Assess the qualification of potential investigative sites, initiate clinical trials at investigative sites, instruct site personnel on the proper conduct of clinical trials, and close clinical trials at investigative sites
- Record site visit activities, including but not limited to, assessments of qualification initiation activities, observations of clinical conduct, instructions/training given to sites, and action items to be completed
- Review and verify accuracy of clinical trial data collected, either onsite or remotely. Provide regular site status information to team members, trial management, and update trial management tools
- Complete monitoring activity documents as required by Toolbox OPs or other contractual obligations
- Work closely with other clinical team members to facilitate timely resolution of trial and/or clinical issues
- Perform essential document site file reconciliation. Perform source document verification and query resolution
- Assess IP accountability, dispensation, and compliance at the investigative sites.
- Communicate with investigative sites
- Ensure all required training is completed and documented
- Facilitate supply management and ensure clinical sites have the necessary supplies to conduct studies according to applicable protocols
- May be assigned additional Clinical Operations tasks
- May serve as a resource for and interact with other functional areas to resolve site issues and facilitate trial timelines
- Help create a fun, rewarding and collaborative environment
What your background should look like:
- Bachelor’s degree required, preferably in a Science discipline
- Minimum of 2 to 3 years of Clinical Research experience (IVD preferred)
- Ability to travel up to 50-75% of the time
- Ability to instill trust in our customers through a dedicated effort to achieve their goals with quality, speed and efficiency
- Ability to handle difficult situations professionally and maintain a professional and caring demeanor
- Proven ability to collaborate in a team environment and work independently
- Must be a team-player, punctual and reliable, dependable and flexible in adapting to change in a multi-disciplinary, fast-paced work environment
- Must be responsible, creative and highly motivated
ABOUT TE CONNECTIVITY
TE Connectivity is a global industrial technology leader creating a safer, sustainable, productive and connected future. Our broad range of connectivity and sensor solutions, proven in the harshest environments, enable advancements in transportation, industrial applications, medical technology, energy, data communications and the home. With approximately 80,000 employees, including more than 7,500 engineers, working alongside customers in approximately 140 countries, TE ensures that EVERY CONNECTION COUNTS. Learn more at www.te.com and on LinkedIn, Facebook, WeChat and Twitter.
- Competitive base salary commensurate with experience: $85 – 105 (subject to change dependent on physical location)
- Posted salary ranges are made in good faith. TE Connectivity reserves the right to adjust ranges depending on the experience/qualification of the selected candidate as well as internal and external equity.
- Total Compensation = Base Salary + Incentive(s) + Benefits
- A comprehensive benefits package including health insurance, 401(k), disability, life insurance, employee stock purchase plan, paid time off and voluntary benefits.
EOE, Including Disability/Vets