job summary: As the world's largest staffing and recruitment agency in the world, we can commit to find you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. Internationally known for creating cutting-edge biopharmaceuticals for patients who live with rare genetic diseases, our partner strives to develop critical therapies for the small population - mostly children - that suffer from near unheard of conditions. If you're looking for an exciting opportunity to make a difference with an established company, this is the position for you!
location: San Rafael, California
job type: Contract
salary: $42.50 - 50.00 per hour
work hours: 9 to 5
The Clinical Trial Specialist performs essential responsibilities for successful trial execution at BioMarin. The Clinical Trial Specialist takes on the key role of Study Specialist, contributing to tasks related to site management and/or study management and oversight activities as delegated by SETL, Study Operations Lead (SOL), or Regional Operations Lead (ROL). This may include contributing to and/or supporting study matters that impact study timelines, quality and budget.
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 done routinely by Clinical Trial Assistant (CTA)
Contracts & Budgets:
- Contribute to the development of vendor specific timelines ensuring alignment with study level timelines
Study Start Up:
- Review and approve invoices for assigned vendors
- Review investigator payment: site setup, pass-through processing, visit payment processing and funding processing in collaboration with DrugDev
- Clinical Operations Managed Vendors & CRO:
- May participate in vendor selection
- Escalate vendor performance and quality issues to the SOL
- 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 Conduct And Close-out:
- Manage activities related to Startup as delegated by the SOL
- Develop study specific documentation as delegated by the SOL
- Confirm that all site level documents have been collected to support site initiation
- Contribute to the IP release process
- Ensure timely study entry and updates to ClinicalTrials.gov
- Provide vendor status updates to the Study Operations Lead
- Identify and escalate issues relating to study delivery, timelines and site budget to Study Operations Lead
- Support study close-out activities (sites, reconciliation activities, filing & archiving)
- Participate in data listing reviews
- Facilitate timely delivery of clinical documents for the CSR and appendices
Drug or Investigational Product (IP):
- 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
- Support SOL to ensure timely delivery of IP to the sites in collaboration with Clinical Supply Chain (CSC) representative
- Ensure that CRO/sites are clear on how IP is to be handled according to pharmacy manual
- Clinical Governance / Team Membership and Leadership:
- Attend internal Clinical Operations team meetings, attend vendor meetings as appropriate, based on assignments from SOL
- Ad hoc attendance at SET Meetings
- 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.
- 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
skills: Clinical Data Management
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.