Clinical Trial Associate
W2 Contract
Salary Range: $124,800 - $145,600 per year
Location: South San Francisco, CA - Hybrid Role
Job Summary:
As a Clinical Trial Associate, you will support the Clinical Operations team on various programs. You will work closely with a cross-functional team to ensure that clinical trials are conducted on time and comply with SOPs, ICH/GCP/regulatory guidelines, company goals, and budgets.
Duties and Responsibilities:
- Track and maintain study information and report on study progress.
- Track and provide IRB/IEC submissions and other supplementary documentation as appropriate.
- Obtain, review, process, and track study-related documents (CVs, FDA 1572s, lab certifications, IRB approvals, contracts, protocols, etc.).
- Maintain and disseminate basic study tracking information, including but not limited to visit reports, regulatory documents, site contact lists, team contact lists, vendor lists, and budget disbursements.
- Manage the contract and CDA signature process; track and request signatures from signature authorities and upload documents to DocuSign.
- File all contracts and amendments in appropriate folders.
- Purchase order set-up and management in Coupa; set up for new contracts, amendments as needed, managing balances, and updating outsourcing tracker.
- Process invoice approvals for AP payments. Forward invoices to Study Leads for review and approval. Act as the liaison for all invoice inquiries.
- Support one or more study execution teams (SETs), including scheduling meetings and distributing agendas and meeting minutes.
- Document outstanding action items with expected completion dates and responsible individual(s). Follow-up on all SET action items.
- Independently maintain the internal Trial Master File (eTMF) per the TMF reference model and periodically review the TMF(s) being maintained by the Contract Research Organization (CRO) to ensure accuracy, completeness, and adherence to the DIA's reference model. Ensure that all documentation is audit-ready. Ensure that the eTMF is archived per applicable standards.
- Assist in preparing materials for investigator meetings and workshops.
- Create Purchase Orders, assist with processing vendor invoices, and work with Clinical Operations and Finance to resolve payment issues.
- Assist with vendor management and associated logistics as assigned.
- May assist with informed consent development and review.
Requirements and Qualifications:
- BS/BA in Life Sciences or related discipline
- 1-2+ years of related experience or a combination of experience and education/training
- Preferred knowledge and understanding of FDA and ICH Guidelines, Good Clinical Practices (GCP), medical terminology, and clinical trials
- Highly proficient in software applications such as Word, Excel, and PowerPoint
- Good written and verbal communication skills and proven ability to multitask
- Efficient time management and organizational skills
- Strong interpersonal skills with a reputation for collaboration with colleagues
- Attention to detail and accuracy in work
Desired Skills and Experience
CTA, clinical trial, FDA, ICH Guidelines, GCP, Word, Excel, PowerPoint. Coupa
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