SITE FEASIBILITY SPECIALIST II

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

The Site Feasibility Specialist II is a highly driven professional who will identify, contact, visit, build, and maintain strong relationships with high performing sites, investigators, and networks for the conduct of feasibility and potential study participation.


Responsibilities:

  • Identify, contact, and build relationships with study investigators/sites and networks in assigned areas (e.g., region, countries, or therapeutic area) for the conduct of feasibility and potential study participation
  • Build investigator database and feasibility management system (e.g., investigator profiles, country demographics)
  • Creates/Coordinate the development of the feasibility questionnaire for a study. Reviews the protocol, seeks expertise from applicable supporting functions (feasibility manger, PM, etc.), & finalizes draft for Sponsor review, as required. Works with PM to
obtain client approval of the study specific feasibility questionnaire, as needed.
  • Create and disseminate Confidential Disclosure Agreements (CDAs)/Questionnaires to sites and follow up accordingly to ascertain interest and to meet study timelines.
  • Adheres to study timelines, documents, and communicates updates to Project Managers.
  • Liaise with the project manager to understand studies’ budgets and negotiates and finalizes budgets with the investigational sites.
  • Responsible for transitioning sites from Site Feasibility to SSU (Study Start Up) representative.
  • Conduct site qualification visits (on-site and remotely)
  • Participate in project team meetings.
  • Leads in training and development of junior staff.
  • May be assigned additional Clinical Operations and Business Development tasks
  • Help create a fun, rewarding and collaborative environment.


KNOWLEDGE, SKILLS & ABILITIES:

  • Knowledge of clinical research process related to feasibility, study start-up and regulatory requirements.
  • Ability to interact effectively with investigators and cross-functional teams; in-vitro diagnostics experience is preferred.
  • Excellent organizational, time management and interpersonal skills with track record for attention to detail.
  • Thorough knowledge of GCP, ICH guidelines and other clinical regulatory requirements.
  • Strong work ethic and demonstrated ability to deliver assignments on time.
  • Strong written and verbal communication skills to express ideas to study personnel, internal and sponsor team members.
  • Ability to travel (up to 25%-50%) to clinical sites.
  • Ability to handle difficult situations professionally and maintain a professional and caring demeanor.
  • Must be able to work independently and within a team environment.
  • 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.

What your background should look like:

  • Bachelor’s degree (or equivalent) in science-related field preferred
  • 2-3 years relevant experience in clinical research, monitoring or study start up
  • Equivalent combination of education, training, and experience

Competencies

SET : Strategy, Execution, Talent (for managers)
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