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Clinical Research Associate I (NON-TRAVELLING)

TE Connectivity

Location: Carlsbad, California

Job Type: Full time

Posted



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

In-House Clinical Research Associate

The In-House Clinical Research Associate will monitor the progress of clinical studies remotely, provide administrative support to other CRAs, as needed, 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:

  • Assist with remote monitoring, including source document verification and ICF review, as applicable, and complete associated monitoring report
  • Support Study Start Up activities, including but not limited to Debarment Checks, Qualification Waivers, etc.
  • Communicate with sites to ensure adequate study supplies are on hand during enrollment
  • Facilitate resolution of data queries/requests from Clinical Data Management
  • Address protocol questions from sites, in consultation with CPM and study team members, if needed
  • When requested by responsible CRA, communicate directly with sites to handle questions/issues
  • Review and identify issues that sites need to address from the regulatory documents collected from Lead CRA
  • Assist with closure of pending action items, including requesting/collecting regulatory documents
  • Provide CRAs with a list of missing documents to help prepare for upcoming monitoring visits
  • Delegate TMF action items to lead CTA
  • Conduct and monitor analytical studies (e.g., Reproducibility, LOD), as requested (local travel may be involved in this instance)
  • Review study data on a periodic basis to identify potential trends
  • Review Reference Lab data for completeness and accuracy (e.g., TriCore)
  • Review QC Logs in real time to look for gaps/failures in QC testing that may impact study testing/results
  • May be assigned additional Clinical Operations tasks

What your background should look like:

  • Bachelor’s degree, in a medical-related or science field highly preferred, or equivalent
  • Minimum of 1 year of experience in a Clinical Research environment preferred
  • 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
  • Demonstrate meticulous attention to detail and data evaluation skills
  • Excellent verbal and written communication skills required
  • Proven ability to collaborate in a team environment
  • Must be responsible, dependable, and punctual and be able to work independently
  • Must be flexible in adapting to change, with effective time management and organizational skills and ability to manage multiple tasks in a multi-disciplinary, fast-paced work environment
  • Proficient in MS Office Suite applications
  • Travel can range from 0 to 10%

Works Closely With:
Regional CRA Supervisors, CRAs, CTAs, Director of Clinical Monitoring and Data Management, Senior Manager of Clinical Operations, Director of Clinical Programs

Competencies

SET : Strategy, Execution, Talent (for managers)

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 more than 85,000 employees, including over 8,000 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 total rewards compensation. Our commitment to our associates includes offering benefit programs that are comprehensive, competitive and will meet the needs of our associates.

  • Generous 401(k) Plan
  • Tuition Reimbursement
  • Benefits start on day one
  • Charity Donation Matching Program
  • Competitive Paid Time Off
  • Employee Resource Groups
  • Employee Stock Purchase Program
  • Healthcare for Associates and Families
  • Health and Wellness Incentives
  • Life Insurance and Disability Protection

Throughout our Global reach and various Business Units, we take a balanced approach to the benefits we provide. Many benefits are company-paid, while others are available through associate contribution. Specific benefit offerings can vary by location.

EOE, Including Disability/Vets