Clinical Research Coordinator

VIVA USA Inc; Palo Alto (CA); Hybrid; USD 75,000 - 110,000; Full time

Job summary

VIVA USA Inc in Palo Alto seeks an experienced Clinical Research Coordinator to manage complex studies, oversee recruitment, data management, and regulatory compliance. The role involves independent handling of tasks and mentoring junior staff.

Hybrid work includes four days on-site during training, then 3-4 days per week on-site with flexibility. You will collaborate with investigators, monitor safety, ensure IRB submissions, and assist budgeting and sponsor invoicing.

Qualifications

• Bachelor's degree in a related field with 2 years in clinical research.
• Experience with study regulatory requirements (HIPAA, FDA, IRB).
• Strong data management and quality control skills.

Responsibilities

• Oversee subject recruitment and enrollment goals for clinical trials.
• Develop and manage data collection, reporting, and monitoring systems.
• Create study schedules, lead meetings, and document minutes.
• Mentor staff and trainees; participate in hiring and evaluations.
• Audit operations for regulatory compliance and implement improvements.
• Collaborate with investigators and sponsors; report adverse events.
• Assist with budgeting, milestone tracking, and sponsor invoicing.
• Ensure IND submissions and IRB renewals are completed when applicable.

Skills

Interpersonal skills

MS Office

Regulatory knowledge

Medical terminology

Education

Bachelor's degree in related field

Tools

EPIC

Job description

Hybrid and onsite 4 days/wk during training then 3-4 per week

JOB PURPOSE:

Conduct clinical research and work independently on progressively more complex projects/assignments. Independently manage significant and key aspects of a large study or all aspects of one or more small research studies.

CORE DUTIES:

• Oversee subject recruitment and study enrollment goals. Determine effective strategies for promoting/recruiting research participants and retaining participants in long‑term clinical trials.
• Oversee data management for research projects. Develop and manage systems to organize, collect, report, and monitor data collection. Extract, analyze, and interpret data.
• Develop project schedules, targets, measurements, and accountabilities, as assigned. Lead team meetings and prepare/approve minutes.
• Formally supervise, train, and/or mentor new staff or students, as assigned, potentially including hiring, preparing or assisting with the preparation of performance evaluations, and performing related duties, in addition to instruction on project work.
• Audit operations, including laboratory procedures, to ensure compliance with applicable regulations; provide leadership in identifying and implementing corrective actions/processes. Monitor Institutional Review Board submissions, and respond to requests and questions.
• Collaborate with principal investigators and study sponsors, monitor and report serious adverse events, and resolve study queries.
• Provide leadership in determining, recommending, and implementing improvements to policies/processes; define best practices.
• Develop study budget with staff and principal investigator, identifying standard of care versus study procedures. Track patient and study specific milestones, and invoice sponsors according to study contract.
• Ensure regulatory compliance. Regularly inspect study document to ensure ongoing regulatory compliance.
• Work with principal investigator to ensure Investigational New Drug applications are submitted to the FDA when applicable. Ensure Institutional Review Board renewals are completed.

Knowledge, Skills and Abilities:

• Strong interpersonal skills.
• Proficiency in Microsoft Office and database applications.
• Experience with research protocols and regulatory or governing bodies, which include HIPAA and FDA regulations, Institutional Review Board requirements, and Good Clinical Practices.
• Knowledge of medical terminology.

Requirements:

MINIMUM REQUIREMENTS:

Education & Experience:

Bachelor's degree in a related field and two years of experience in clinical research, or an equivalent combination of education and relevant experience.

Certifications and Licenses:

Society of Clinical Research Associates or Association of Clinical Research Professionals certification is preferred.

Top 3 requirements to hire

Absolutely need onsite coordinator experience (not data, project manager, or regulatory), EPIC experience, Oncology and treatment trials

Notes:

• Number of hours per week: 40
• Hybrid and onsite 4 days/wk during training then 3-4 per week

VIVA is an equal opportunity employer. All qualified applicants have an equal opportunity for placement, and all employees have an equal opportunity to develop on the job. This means that VIVA will not discriminate against any employee or qualified applicant on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status