Clinical Research Associate

ALOIS Solutions; Palo Alto (CA); On-site; USD 100,000 - 167,000; Full time

Job summary

ALOIS Solutions in Palo Alto, CA seeks an onsite Clinical Research Coordinator for a 6-month contract with potential extension. You will independently manage key aspects of oncology and treatment trials, ensuring data integrity and regulatory compliance.

Responsibilities include data management, protocol adherence, IRB coordination, and collaboration with principal investigators and sponsors. The role requires a Bachelor’s degree in a related field and two years of clinical research experience.

Qualifications

• Bachelor's degree in a related field and two years of experience in clinical research, or an equivalent combination of education and relevant experience.
• Experience with research protocols and regulatory or governing bodies, including HIPAA and FDA regulations, IRB requirements, and Good Clinical Practices.
• Knowledge of medical terminology.

Responsibilities

• Conduct clinical research and independently manage progressively complex projects or studies.
• Oversee data management: organize, collect, report, and monitor data collection; extract, analyze, and interpret data.
• Audit operations and laboratory procedures to ensure regulatory compliance; monitor IRB submissions and respond to requests.
• Collaborate with principal investigators and study sponsors; monitor and report serious adverse events, resolve study queries.

Skills

Medical terminology

Onsite coordination

Clinical research

Regulatory knowledge

Education

Bachelor's degree in a related field

Job description

Duration: 6 Months with a high possibility of extension

Job Description:

• 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.
• Oversee data management for research projects. Develop and manage systems to organize, collect, report, and monitor data collection. Extract, analyze, and interpret data.
• 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.
• 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.
• Bachelor's degree in a related field and two years of experience in clinical research, or an equivalent combination of education and relevant experience.
• Absolutely need onsite coordinator experience (not data, project manager, or regulatory), Oncology and treatment trials