Senior Clinical Trial Associate

Responsibilities:
- Support study start-up activities including site feasibility, site selection documentation, and site activation deliverables (regulatory packets, essential documents, training records).
- Coordinate collection, review, and filing of site regulatory documents (e.g., CVs, medical licenses, FDA 1572/financial disclosures, delegation logs).
- Track site start-up progress, action items, and timelines; escalate risks or delays to the Clinical Operations Manager.
- Maintain study tracking tools for operational activities (site activation, enrollment, monitoring visit status, IRB/EC approvals, safety letter distribution).
- Coordinate study communications and meetings (agendas, minutes, follow-up actions) and distribute study materials to sites, CROs, and vendors.
- Support site maintenance and closeout activities (outstanding documents, reconciliation of logs, site/vendor queries).
- Participate in data cleaning activities as directed by the Clinical Operations Manager.
- Partner with CROs and vendors to ensure timely exchange and filing of essential study documents; support access/permissions/troubleshooting for study systems.
- Maintain accurate study information in clinical systems (eTMF, CTMS, eISF portals) with timely updates, quality checks, and completeness.
- Participate in system UAT as needed.
- Manage eTMF for assigned studies (document processing, metadata quality, periodic QC, completeness checks).
- Support development/review/distribution of study documents (study plans, trackers, templates, site communication packages).
- Assist with audit/inspection readiness (TMF remediation, file reconciliation, review preparation).
- Collaborate with Regulatory, Clinical Supplies, Data Management, Safety, and Quality to align on timelines and deliverables.
- Ensure activities follow Immunome SOPs, GCP, and applicable regulations; identify and communicate compliance risks and mitigations.
- Contribute to process improvements by refining trackers, templates, and SOPs; share best practices.

Qualifications:
- Bachelor’s in Life Sciences, Nursing, or related field (or equivalent education/experience).
- 2–3+ years biotech/pharmaceutical Clinical Research experience with increasing responsibility.
- Working knowledge of ICH-GCP and relevant regulatory requirements; audit/inspection support experience is a plus.
- Hands-on experience managing trial documentation and TMF/eTMF processes; familiarity with systems (e.g., Veeva Vault eTMF/CTMS or similar) preferred.
- Experience supporting study start-up, including site regulatory document collection and IRB/EC submission support, strongly preferred.
- Experience working with CROs, vendors, and investigative sites; ability to coordinate deliverables across stakeholders.
- Oncology clinical trial experience and/or biotech environment experience strongly preferred.

Knowledge & Skills (required/preferred):
- Strong understanding of clinical trial documentation standards and TMF structure/purpose.
- Excellent organizational skills and attention to detail; maintain trackers and competing deadlines.
- Professional communication with internal and external partners (sites, CROs, vendors).
- Proficiency in Microsoft Office (Word, Excel, PowerPoint); ability to learn new clinical systems/processes. Smartsheet proficiency preferred.
- Proactive issue identification, follow-through on action items, and appropriate escalation.
- Ability to work independently and thrive in cross-functional teams.
- Strong problem-solving and continuous-improvement mindset.
- Commitment to quality and compliance; ownership of inspection-ready documentation.

Benefits/Pay Range:
- Washington State pay range: $95,000 - $135,000 USD.