Senior Clinical Research Associate
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 Senior Clinical Research Associate (CRA) will manage and 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.
- Analyze process workflow; implement operational changes in coordination with Director Perform the management of 1-2 Clinical Studies at a time.
- Serve as the main contact and liaison for project specific client and communicates with investigative sites
- 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
- Research and learn project indication.
- Participate in team meetings with clients and keep project team members informed of study progress, issues and potential timeline delays by preparing weekly updates.
- Identify and negotiate contract and budget of clinical sites for the project.
- Generate clinical study documents such as Protocols, ICFs, Source Documents, and Monitoring Plans
- Complete monitoring activity documents as required by Toolbox SOPs or other contractual obligations
- Review vendor contracts and budgets
- Develop and manage study timelines.
- Complete, maintain and close IRB submissions.
- Ensure CRAs assigned to project are scheduled appropriately for SIVs, IMVs and SCVs.
- Identify study-related issues, confirms resolution, and ensures proper documentation through Toolbox Event system.
- Assist Clinical Trial Assistant with generating and ordering Study supplies
- Assist Clinical Trial Assistant with generating contents list of Enrollment Kits
- Ensure the maintenance of essential documents in TMF.
- Review CRA reports.
- Transfer of TMF and all study supplies to client.
- 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
- Perform essential document site file reconciliation. Perform source document verification and query resolution
- Assess IP accountability, dispensation, and compliance at the investigative sites.
- Ensure all required training is completed and documented
- May serve as a resource for and interact with other functional areas to resolve site issues and facilitate trial timelines
- May be assigned additional Clinical Operations tasks
- Help create a fun, rewarding and collaborative environment
What your background should look like:
- Bachelor’s degree in the Life Sciences or related field required; advanced degree (Master’s or above) preferred
- Pursuing a certification as a CCRP or CCRA
- Extensive experience (5+ years) as a CRA including the ability to interact effectively with investigators and cross-functional teams; in vitro diagnostics experience is preferred
- Thorough knowledge of GCP, GLP, ICH guidelines and other U.S. and international clinical regulatory requirements
- Strong work ethic and demonstrated ability to deliver assignments on time
- Ability to travel (up to 50-75%)
- 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: $90 – 130K (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