job summary: Clinical Trial Specialist Job Summary
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.
location: San Rafael, California
job type: Contract
salary: $24.52 - 28.85 per hour
work hours: 9 to 5
responsibilities: Job Responsibilities
- 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.
- 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
qualifications: Education & Qualifications
- 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
- 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.
- Medical, Dental, and Vision Insurance
- 401K Plan with Company Match
- Life and AD&D Insurance
skills: Clinical Study Design, Study Planning, ICH Regulations, TMF
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance.
We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.