ABOUT THE JOB

The Clinical Research Associate II is an integral part of the Clinical Affairs team who supports clinical trials for Visby. The ideal candidate is highly detail-orientated, self-motivated team player who demonstrates individual initiative and problem-solving capabilities in a collaborative team environment. Due to the nature of this role and interactions with key site team members, the individual will have a high level of professionalism and discretion. You will be responsible for conducting in vitro diagnostics clinical studies in a fast-paced environment located in San Jose, California. This role will report to the Director, Clinical Affairs or appropriate designee.

HOW YOU’LL MAKE AN IMPACT

• Create monitoring plans, case report forms, informed consent forms, and other required documents for clinical studies.
• Develop and write clinical protocols with guidance.
• Serves as a lead CRA conducting site qualification, selection, initiation, monitoring, and closeout visits in compliance with GCP and approved protocols; write site visit reports timely.
• Approves data management plan.
• Establish and update various databases for clinical study monitoring and tracking.
• Collaborate with Data Manager and/or Clinical Affairs management to define data management plan and design CRFs.
• Negotiate budgets and prepare contract agreements with study sites, vendors and CROs, as applicable.
• Provide training to study sites; review study site documents (e.g., regulatory documents, investigational product accountability logs and source documents).
• Maintain effective, professional, timely, and consistent communications with clinical site PIs, coordinators and other site personnel.
• Identify and report issues, problems or any protocol deviations that could affect the studyresults and completion timeline; propose solutions to the Director.
• Create, update, and maintain study TMFs for completeness, compliance and accuracy.
• Ensure timely completion of the clinical deliverables according to project timelines.
• Review and submit invoices received from sites and maintains accurate accruals.
• Ensure studies are conducted in accordance with GCP, US FDA regulations and OUS IVD regulations (as applicable).
• Prepare clinical study reports and relevant sections of regulatory submissions with guidance.
• Perform specialized functions within the clinical affair departments, such as management of clinical research assistants, lead TMF audit, mentor team member, provide training, and/or write SOPs as appropriate.
• Actively participate in optimization of department practices to ensure compliance and drive efficiency.
• Perform other duties and projects as assigned.

ON YOUR FIRST DAY WE’D LIKE YOU TO HAVE

• Minimum Bachelor’s Degree, preferably in a life science or health science discipline.
• Minimum 3 years of related experience, preferably including clinical research and clinical operations experience.
• Experience working in IVD clinical studies highly preferred.
• Computer software skills (e.g., MS Word, Excel, PowerPoint and Google products experience).
• Strong attention to detail, self-motivation, and good 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 ICH GCP.

MORE ABOUT THE TEAM

Our Clinical Affairs team is dedicated to support the clearances/approvals for Visby’s innovative IVD products.

UNIQUE ASPECTS OF THIS JOB (examples)

• Travel:  Approximately 20-30% travel is required.
• Physical aspects: Comfortable performing repetitive tasks and/or motions.  Must be able to lift a minimum of 10 lbs.

SALARY RANGE:

• $95,000 - $125,000 (Minimum to maximum salary range for candidates based in San Jose, CA)
• $80,000 - $110,000 (Minimum to maximum salary range for candidates regionally)
• 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.