Clinical Trial Associate

This is a fully remote position, open to applicants in California.

📋 Description

• Assist Clinical Research Associates (CRAs) and study teams throughout Karius clinical trials.

• Gather, perform quality control, and assure the quality of study and trial-associated regulatory documents.

• Establish and uphold Trial Master Files (TMFs) in accordance with sponsor Standard Operating Procedures (SOPs), the TMF Reference Model, ICH-GCP, and relevant regulatory standards.

• Evaluate, organize, and maintain regulatory documents accurately and swiftly within the TMF.

• Identify gaps in the TMF and monitor the resolution of missing or outstanding documents.

• Liaise with clinical sites and study teams to request and follow up on pending documents.

• Maintain Investigator Site Files (ISFs).

• Create and manage study templates, trackers, forms, and other essential study tools.

• Organize study materials using Google Sheets, Docs, and Drive.

• Prepare TMF and ISF documentation for audits and inspections.

• Assist in the planning, coordination, logistics, and follow-up of investigator meetings.

• Maintain communication and distribution lists for the study.

• Aid in the collection and tracking of study start-up documentation.

• Monitor study milestones, deliverables, and action items.

• Coordinate study meetings, including scheduling, agendas, materials, meeting notes, and action items.

• Assist with document archiving and study closeout activities.

• Provide administrative and operational support to clinical study teams.

⛳️ Requirements

• A Bachelor's degree in life sciences, health sciences, clinical research, or a related discipline, or equivalent education and experience.

• 1-3 years of experience in clinical research, clinical operations, regulatory documentation, or a similar environment.

• Basic comprehension of clinical research processes and compliant execution of clinical trials.

• Familiarity with Trial Master Files (TMFs), Investigator Site Files (ISFs), or other clinical study documentation systems, or the capability to quickly learn relevant processes and standards.

• Basic knowledge of, or a willingness to learn, ICH-GCP, FDA regulations, and other pertinent clinical research requirements.

• Familiarity with medical and clinical research terminology, or the ability to rapidly acquire technical terminology.

• Strong attention to detail with the capacity to review documentation for completeness, accuracy, consistency, and proper filing.

• Excellent organizational and time management skills; ability to handle multiple tasks, maintain trackers, follow up on pending items, and meet deadlines.

• Excellent written and verbal communication abilities.

• Capability to adhere to established procedures, integrate feedback, and work effectively under guidance.

• Proven accountability, reliability, and follow-through.

• Proficiency in Microsoft Office Suite and Google Workspace.

• Ability to learn clinical research systems and document management platforms.

• Ability to thrive in a collaborative, fast-paced environment while upholding accuracy, confidentiality, and attention to detail.

🏝️ Benefits

• Travel required up to 10-20%.

• Equal employment opportunities and a commitment to workplace diversity and inclusion.

• Accommodation for qualified individuals with disabilities.