Bayside Solutions is seeking a Clinical Trial Specialist to be part of our client’ s team in Novato. This is an opportunity to work with the largest privately held pharmaceutical corporation in the world and ranks among the world' s 20 leading pharmaceutical corporations.
Our Client’ s culture is highly collaborative, offers an environment that encourages employees to expand their knowledge in order to make a profound impact on patients’ lives. This could explain why their company has been recognized as one of the “ Top Twenty Employers” in biotechnology and pharmaceuticals by Science Careers.
Our Company Bio: Bayside Solutions was founded in 2001, Bayside was recognized as one of the fastest growing professional staffing companies in Northern California. The numbers tell the story: We have close to a 100% client retention rate, 700% growth in four plus years and over 95% repeat business. Our dedication to building partnership relationships with both our clients and our recruits is the key to our phenomenal success.
You can find additional information on our company website at www.baysidesolutions.com.
Clinical Trial Specialist
- An opportunity to join a patient-focused organization that is driven to develop, manufacture and commercialize medicines to treat life threatening conditions.
- Work for a company that is local to the bay area and recognized as a leader of innovation.
- Competitive compensation commensurate with experience.
- This position is eligible for medical, vision, dental benefits, paid sick time, and 401K.
Summary of Responsibilities:
- The Clinical Trial Specialist performs essential responsibilities for successful trial execution.
- 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.
- Assist with study coordination activities
- Conduct study tracking support (e.g., CTMS tracking, start-up tracking, milestone tracking, close-out tracking) and study updates Assist with inspection readiness activities File, track and maintain TMF Maintain internal/external contact list Conduct electronic documentation and records management.
- Perform document tracking and signature/approval follow-up, where applicable, including Confidential Disclosure Agreements (CDAs), contracts, proposals, payments, invoices, and other study documentation
- Execute meeting logistics (e.g., meeting minutes, expense reports, and travel coordination)
- Ensure timely study entry and updates to ClinicalTrials.gov Prepare investigator meeting materials Design and prepare study related materials for the training of internal and external staff.
- Assist or lead in study conduct activities.
- Facilitate CDA and contract execution.
- Assist with regulatory package review.
- Request and distribute insurance certificates for sites – as delegated by, and under the oversight of, Study Lead Contact and identification of investigators for participation in clinical studies Provide administrative assistance with internal and external meetings including investigator meeting(s).
- Assisting in the management of CRO deliverables (from meeting minutes to finalized ICF) Ensure accurate study entry and updates to ClinicalTrials.gov throughout life of study.
- Issues identification, resolution, and escalation Track site payments and vendor invoices Track patient status.
- Review of study ICFs and other study documents Assist with samples reconciliation and query resolution.
- Conduct MVR review and appropriate escalation of identified issues Assist with MVR tracking and filing of sponsor comments Identify issues, with potential resolution, and escalate when appropriate.
- Conduct study closure activities (sites, reconciliation activities, filing & archiving) Track, collate clinical trial documentation related to CSR appendices Cross-functional Representation
- Assist with cross-functional meeting coordination and minutes Assist study supplies management.
- Lead TMF close-out activities, including document review, uploading and reconciliation.
Summary of Qualifications:
- Education: BA/BS or higher in nursing, life or health sciences is preferred. Industry or relevant experience in lieu of education is considered.
- 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.
- 2+ years pharmaceutical industry experience.
- A proactive problem solver who shows flexibility and an ability to communicate at all levels of an organization.
- The Clinical Trial Specialist is expected to be in the process of developing foundational competence in critical areas required for 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.