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SR CLINICAL RESEARCH ASSOCIATE

Job Posting Title: SR CLINICAL RESEARCH ASSOCIATE  
Job Code: 30005068    
Business Unit: MEDICAL (50126885)  
Building: Spain Virtual Location (903-ES)  
Band/Level: 5-2-C  
Hiring Manager: Susan Lynn Kennedy  
Recruiter: Nerea Rosa Barros  
Relocation: No  
Travel: 50% to 75%  
Employee Referral Amount:  
Education Experience: Bachelors Degree (High School +4 years)  
Employment Experience: 3-5 years  


At TE, you will unleash your potential working with people from diverse backgrounds and industries to create a safer, sustainable and more connected world. 
 

Job Overview

The Senior Clinical Research Associate (Sr. 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.  

Responsibilities

  • Implement and monitor clinical trials to ensure Sponsor and Investigator obligations are being met and are compliant with ICH/GCP guidelines and applicable local regulatory requirements 
  • Prospect and communicate with potential European investigative sites
  • Identify and negotiate contracts and budgets for clinical sites, as required 
  • Review vendor contracts and budgets, as required
  • Research and learn project indication, if applicable
  • Assist with generation of clinical study documents such as Protocols, ICFs, Source Documents, and Monitoring Plans, as required
  • 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 and facilitate query resolution, 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 Clinical Research OPs or other contractual obligations
  • Work closely with other clinical team members to facilitate timely resolution of trial and/or clinical issues
  • Ensure all required training is completed and documented
  • Perform essential document site file reconciliation
  • Assess IP accountability, dispensation, and compliance at the investigative sites
  • 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 be assigned additional tasks with Usability Testing
  • May serve as a resource for and interact with other functional areas to resolve site issues and facilitate trial timelines
  • Analyze process workflow; implement operational changes in coordination with Management Team
  • 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
  • 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 ICH/GCP guidelines and other international clinical regulatory requirements; EU Medical Device Research (MDR) and or In Vitro Diagnostic Regulation (IVDR) expertise preferred
  • Ability to travel up to 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
  • Must demonstrate strong work ethic and ability to deliver assignments on time
  • Must be bi-lingual, written and verbal (English and Spanish)

Competencies

Values: Integrity, Accountability, Teamwork, Innovation

About TE Connectivity
TE Connectivity is a $12 billion 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.

What TE Connectivity offers:

We offer competitive rewards & compensation. Our commitment to our employees includes offering benefit programs that are comprehensive, competitive and will meet the needs of our employees.
•    Competitive Salary Package
•    Performance-Based Bonus Plans
•    Health and Wellness Incentives
•    Employee Stock Purchase Program
•    Community Outreach Programs / Charity Events
•    Employee Resource Groups

Location: 

#Gipuzkoa, SS, ES, 20500

City:  #Gipuzkoa
State:  SS
Country/Region:  ES
Travel:  50% to 75%
Requisition ID:  94438
Alternative Locations:  #Barcelona #Valencia #Madrid
Function:  Engineering & Technology


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