ABOUT THE JOB

The Clinical Research Associate (CRA) is responsible for assisting the clinical team with the conduct of qualification, initiation, monitoring and close out visits at research sites in compliance with approved protocols to ensure protocol adherence, assuring timely enrollment of patients and retrieval of CRFs from study sites, processing CRFs including data cleanup and classification of data, and completion of study summary.

HOW YOU’LL MAKE AN IMPACT

• Assist the clinical team with conducting qualification, initiation, monitoring, and closeout visits at research sites in compliance with approved protocols.
• Establish and update various databases for clinical tracking.
• Communicate with medical site staff including coordinators, clinical research physicians and their staff.
• Create, update, track, and maintain study-specific trial management files.
• Maintain effective, professional, timely, and consistent communications with clinical sites.
• Support clinical research start-up activities (includes crate of study logs, work instructions, case report forms, and other study materials).
• Ensure delivery according to project timelines.
• Order, ship, and maintain clinical study supplies and in-house clinical inventory.
• Ship and track investigational materials to study sites.
• Prepare study binders for the clinical sites.
• Coordinate technical support for field monitors.
• Assist the clinical team with administrative activities as required (e.g. payments to investigators, travel planning, etc.).
• Assist with preparing, copying, and printing regulatory submission documents.
• Assist with coordinating and conducting testing in support of regulatory submissions.
• Other duties as assigned.

ON YOUR FIRST DAY WE’D LIKE YOU TO HAVE

• Bachelor’s Degree, preferably in a life science or health science discipline.
• Minimum 1-2 years of experience working in the healthcare industry or in a research function which involved clinical research and clinical operations.
• Start-up experience preferred.

IT’S GREAT IF YOU HAVE

• Strong computer software skills (MS Word, Excel, Outlook, PowerPoint, and Access experience).
• Strong communication and presentation skills.
• Strong attention to detail, self-motivation, and good time management & organizational skills.
• Ability to multi-task and ability to work both as part of a team and independently.
• Proactive approach, with high sense of urgency and results orientation.
• Progressive thinker, innovative and open-minded.
• High levels of integrity, intellectual honesty and maturity.
• Knowledge of FDA requirements for clinical validation and CLIA waiver.
• Knowledge of FDA, ICH, and GCP requirements.

UNIQUE ASPECTS OF THIS JOB (examples)

• Travel: Approximately 20-30% travel is required.
• Schedule: Hybrid position requiring to be onsite 3 days a week

SALARY RANGE:

• $70,000 - $80,000 (Minimum to maximum salary range for candidates based in San Jose, CA)
• Compensation for the role is based on geographical location.
• Compensation also depends on a number of factors including a candidate’s qualifications, skills, competencies and experience and may fall outside of the range shown.