Clinical Research Coordinator

Description

Job Title: Clinical Research Coordinator

Location Address: Palo Alto, CA 94304 (Onsite 5 days per week)

Duration of project (start and end date): ASAP to 6 months (Tentative Start Date: 01-Jul-2026; Tentative End Date: 31-Dec-2026)

Shift timing/schedule: Day business hours

Will the resource be working with minors? No

How many years of experience are required? 2+

Will this role extend or possibly convert to an FTE? Yes

PR Range: $40/hr - $51/hr on W2

Top 3 requirements to hire? Oncology treatment trials, Phase I, EPIC and onsite at a health institution (not looking for CRO or Pharma CRA experience)

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 a study budget with the staff and principal investigator, identifying the standard of care versus study procedures. Track patient and study-specific milestones, and invoice sponsors according to the study contract.

Ensure regulatory compliance. Regularly inspect the study document to ensure ongoing regulatory compliance.

Work with the principal investigator to ensure Investigational New Drug applications are submitted to the FDA when applicable. Ensure Institutional Review Board renewals are completed.

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.

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.

Certifications and Licenses:

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

PHYSICAL REQUIREMENTS*:

Frequently stand, walk, twist, bend, stoop, squat, and use fine light/fine grasping.

Occasionally sit, reach above shoulders, perform desk-based computer tasks, use a telephone, and write by hand, lift, carry, push, and pull objects that weigh up to 40 pounds.

Rarely kneel, crawl, climb ladders, grasp forcefully, sort and file paperwork or parts, rarely lift, carry, push, and pull objects that weigh 40 pounds or more.

Ability to drive day or night, if applicable.