Clinical Trial Specialist

San Rafael, CA 94901

Posted: 10/25/2018 Employment Type: Contract Industry: Research Job Number: 5023

Duties: We are currently looking for the best and brightest talents to join our team. The ideal candidate would be a clinical research professional passionate about operations with a minimum of 2 years’ experience in Clinical Operations, focused on working to ensure delivery of quality data, and committed to helping our patients. A proactive problem solver who shows flexibility and an ability to communicate at all levels of an organization.

The Clinical Trial Specialist (CTS), is a critical team member in Clinical Operations. As a CTS, you will have a unique opportunity to participate in a wide range of operational activities related to clinical trial execution. Expect also to contribute to or lead tasks related to study and site management during start-up, conduct and close-out. Other key responsibilities cover vendor management and oversight. Altogether, this position provides you with an exceptional foundation for your career and professional growth.

The Clinical Trial Specialist can be partly or fully responsible for the following areas depending on his/her level of proficiency. Responsibilities may include, but are not limited to:

 

Quality:

Ensure TMF filing and maintenance is routinely doneTimelines:

Contribute to the development of vendor specific timelines ensuring alignment with study level timelines

Contracts & Budgets:

Review and approve invoices for assigned vendors Review investigator payment: site setup, pass-through processing, visit payment processing and funding processing.

Clinical Operations Managed Vendors:  

May participate in vendor selection

Escalate vendor performance and quality issues

Protocol & Informed Consent Form (ICF) Development Process:

 

Create and maintain tracker for future amendment changes Actively contribute to the review of any changes to the ICF Master Ensure alignment of country/site specific ICFs with ICF Master

Study startup, conduct and close-out:

A diverse set of operational responsibilities related to the startup, the conduct and the close-out of clinical trials.

 

Insurance:

 
  • Ensure an insurance policy is in place for the country and, if applicable, the individual clinical trial sites associated with the protocol and protocol amendments Ensure the required information/documents needed to obtain insurance are made available to CTA
  • Oversee extensions of expiring policies and processing of certificates, as appropriate

 

Skills:

  • The Clinical Trial Specialist is expected to be in the process of developing foundational competence in critical areas required for long term success in Clinical Operations across Communication and Collaboration, Proactivity and Adaptability, Strategic Thinking, Planning and Analysis, and Problem solving and Decision Making. For example:
    • Responds promptly with clear, organized written and oral communication Seeks out, and understands the value of, opportunities to interact with peers and stakeholders; builds a network of internal and external peers Takes ownership and accountability for completing assigned tasks and perseveres through obstacles Embraces new challenges or changed priorities and adjusts plans and priorities accordingly
    • The Clinical Trial Specialist is also in the process of developing foundational technical competence in Study Management and Execution, Compliance and Quality, Drug Development and Study Design, and Product and Therapeutic Area Knowledge.

 

Education:

  • BA/BS or higher in nursing, life or health sciences is preferred. Industry or relevant experience in lieu of education is considered.
  • 2+ years pharmaceutical industry experience
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