Clinical Research Coordinator

ALOIS Solutions; Palo Alto (CA); On-site; USD 62,000 - 103,000; Full time

Job summary

ALOIS Solutions is seeking a dedicated onsite coordinator to conduct clinical research and independently manage progressively complex projects. You will oversee data management, develop data collection systems, and extract and interpret results to support study decisions.

The role requires knowledge of HIPAA, FDA regulations, IRB requirements, and Good Clinical Practices, with a strong emphasis on onsite coordination and regulatory compliance.

Qualifications

• Experience with regulatory or governing bodies (HIPAA, FDA) and IRB requirements.
• Strong proficiency with Microsoft Office and database applications.
• Knowledge of medical terminology.
• Onsite coordinator experience required (not data/project manager/regulatory).

Responsibilities

• Conduct clinical research and work independently on progressively more complex projects/assignments.
• 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.
• Lead team meetings and prepare/approve minutes.
• Audit operations, including laboratory procedures, for compliance; lead corrective actions.
• Collaborate with principal investigators and study sponsors; monitor and report serious adverse events.
• Develop study budget with staff and PI, distinguishing standard of care from study procedures.
• Track milestones and invoice sponsors per contract.

Skills

MS Office & databases

Regulatory/IRB knowledge

Medical terminology

Onsite coordinator experience

Job description

Duration: 6 Months (High Possibility of Extension)

Responsibilities:

• Conduct clinical research and work independently on progressively more complex projects/assignments.
• 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.
• Audit operations, including laboratory procedures, to ensure compliance with applicable regulations; provide leadership in identifying and implementing corrective actions/processes.
• Collaborate with principal investigators and study sponsors, monitor and report serious adverse events, and resolve study queries.
• 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.

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.
• Absolutely need onsite coordinator experience (not data, project manager, or regulatory)