Clinical Research Coordinator – Hybrid

VIVA USA INC; Palo Alto (CA); Hybrid; USD 70,000 - 95,000; Full time

Job summary

VIVA USA INC seeks a Clinical Research Coordinator to conduct and oversee clinical research projects with a hybrid work model in the US. The role emphasizes recruitment, data management, regulatory compliance, and collaboration with investigators and sponsors.

The ideal candidate has a bachelor’s degree with clinical research experience, knowledge of IRB/GCP, and experience with EPIC and oncology trials. Hybrid schedule and cross-functional collaboration are key.

Qualifications

• Bachelor’s degree in a related field and clinical research experience or equivalent combination.
• Experience with regulatory requirements and GCP/IRB processes.
• Strong data management and documentation skills.

Responsibilities

• Oversee subject recruitment and enrollment goals with strategies for retention in trials.
• Manage data collection, reporting, and data quality across studies.
• Develop project schedules, targets, and accountabilities; lead meetings and document actions.
• Supervise and mentor staff, including performance evaluations.
• Audit operations and regulatory compliance; monitor IRB submissions and responses.
• Collaborate with investigators and sponsors; monitor adverse events and resolve queries.
• Contribute to policy improvements and standard operating procedures.
• Develop study budgets, track milestones, and invoice sponsors per contract.
• Ensure regulatory compliance and prepare regulatory submissions as needed.
• Work with investigators on IND filings with FDA when applicable.

Skills

Recruiting

Data management

Data collection

Audit operations

Study sponsors

IRB requirements

Good Clinical Practices

Medical terminology

Clinical research

Microsoft Office

Database applications

Research protocols

Research regulatory

Governing bodies

Education

Bachelor’s degree in a related field

Tools

Microsoft Office

EPIC

Job description

Clinical Research Coordinator – Hybrid

MANDATORY SKILLS:

• recruiting research
• data management
• data collection
• Audit operations
• study sponsors
• Institutional Review Board requirements
• Good Clinical Practices
• medical terminology
• Audit operations
• Drug applications
• Oncology
• clinical research
• Microsoft Office
• database applications
• research protocols
• research regulatory
• governing bodies

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

VIVA USA is an equal opportunity employer and is committed to maintaining a professional working environment that is free from discrimination and unlawful harassment. The Management, contractors, and staff of VIVA USA shall respect others without regard to race, sex, religion, age, color, creed, national or ethnic origin, physical, mental or sensory disability, marital status, sexual orientation, or status as a Vietnam‑era, recently separated veteran, Active war time or campaign badge veteran, Armed forces service medal veteran, or disabled veteran. Please contact us at for any complaints, comments and suggestions.

CONTACT DETAILS:

Account co-ordinator: Ramadas Kumaresan

VIVA USA INC.

3601 Algonquin Road, Suite 425

Rolling Meadows, IL 60008