Clinical Trial Assistant (Temporary)
Location: Emeryville, CA
Department: Clinical Development - MDS
Headquartered in Emeryville, CA, Zogenix is a biopharmaceutical company committed to developing and commercializing transformative therapies to improve the lives of patients and their families living with rare diseases. We are currently looking to hire an Clinical Trial Assistant (CTA). This is an exciting opportunity to join the Clinical Operations team at Zogenix and support global clinical trials. The role will be based in our Emeryville office.
The Clinical Trial Assistant provides support to cross-functional teams in the coordination, execution and maintenance of clinical studies supporting the planning, start-up, maintenance and closeout of study activities conducted within the Clinical Operations Department, in compliance with the protocol, Good Clinical Practice (GCP) and applicable regulations and in accordance with Zogenix Standard Operating Procedures. This role requires substantial understanding of the job to apply knowledge and skills to a wide range of tasks. This role supports new and ongoing clinical research and ensures adherence to timelines while maintaining high quality and integrity in their execution.
Responsibilities and Duties
- Conducts study tracking support (eg. CTMS, study start up metrics and milestones, patient enrolment, drug shipments etc)
- Assists with in-house reconciliation of IWRS queries to ensure compliance with case report forms (EDC), protocol, pharmacy manual and Standard Operating Procedures (SOPs).
- Assists in identifying sites for oversight visits based on pre-specified criteria (i.e., repeat major deviations, failure to perform drug accountability appropriately, etc.
- Manages the collection, review, and approval of regulatory and essential documents from clinical sites
- May have some responsibility for ordering and shipping supplies in coordination with all phases of the clinical studies, maintains files and inventories of chemicals, supplies and equipment.
- Assists with the submission of protocols, amendments, subject facing documents to Independent Ethics Committees/Institutional Review Boards (IRBs) and coordinates responses to queries, as required
- Performs document tracking and signature/approval follow-up where applicable eg Confidential Disclosure Agreements, contracts, payments, invoices and other study documentation
- May be responsible for timely study entry and updates to CT.Gov and other competent authority platforms
- Manages and maintains the TMF and assists the Study Lead in QC- related activities
- Interfaces with site coordinators, field clinical staff, CROs and other company representatives
- May assist in the performance of study feasibility assessments
- In collaboration with Clinical Supply, Regulatory, coordinates investigational product release activities across clinical sites ensuring proper drug shipments and returns and assisting where necessary with in-house reconciliation
- Assists in the meeting coordination and facilitation as well as the preparation of Investigator and Study Coordinator Meetings
- Maintains clinical operations files, databases and tracking systems and reports study metrics to support the clinical trial programs
- Participates in and presents status updates in project team meetings
- Assists in User Acceptance Testing for various clinical systems
- Other duties as required
Qualifications and Skills
- 2+ years of experience in a similar role in the life science industry preferred
- Substantial understanding of the role and able to apply this knowledge and skills to a wide range of tasks
- Has an understanding of FDA and EU regulations, ICH Guidelines and GCP requirements governing the conduct of clinical trials.
- Able to work on assignments requiring judgement to resolve issues or to make recommendations as needed
- Good written and verbal communication skills
- Ability to with little instruction and multitask under pressure
- Effective organizational skills with the ability to prioritize as needed and with strong attention to detail
- Understands and can work with budgetary information
- Able to apply problem-solving and analytical skills to day to day tasks
- Proficient in software applications such as Word, Excel and PowerPoint
- Models our core values: Compassion, Courage, Collaboration and Excellence