Clinical Research Coordinator

Avispa MedOps; Palo Alto (CA); Hybrid; USD 45,000 - 65,000; Part time

Benefits offered by this job

Group Medical

Dental

Vision

Life Insurance

Retirement Savings Program

PSL

Job summary

A leading university seeks a Clinical Research Coordinator to coordinate clinical studies from start-up through closeout, including participant enrollment, data management, and regulatory compliance. The role is hybrid in Palo Alto, CA, with a 40/hr wage and a 6-month assignment that may extend.

Responsibilities include coordinating studies, managing data, ensuring protocol compliance, and assisting with regulatory submissions and budget monitoring. Experience with EPIC and EMR is preferred.

Qualifications

• Coordinate clinical studies from start-up through closeout.
• Assist in regulatory submissions and IRB renewals.
• Experience with data collection, management, and regulatory compliance.

Responsibilities

• Coordinate moderately complex aspects of one or more clinical studies from start-up through closeout under close direction of the PI.
• Determine participant eligibility and obtain consent per protocol; assist in recruitment strategies.
• Collect and manage patient/lab data; maintain study databases and case report forms.
• Ensure compliance with protocols; audit CRFs; prepare regulatory submissions and monitor visits.
• Assemble study kits, monitor scheduling, and assist in budget adherence with finance.

Skills

Regulatory compliance

Recruitment coordination

Clinical data management

Microsoft Office

Sponsor/IRB liaison

Education

Associate degree in related field

Bachelor's degree in related field

Equivalent combination of education and experience

Tools

EPIC

Electronic Medical Records (EMR)

Job description

Clinical Research Coordinator 1519284

• Hourly pay: $40/hr
• Worksite: Leading university (Palo Alto, CA 94304 - Hybrid)
• W2 Employment, Group Medical, Dental, Vision, Life, Retirement Savings Program, PSL
• 40 hours/week, 6 Month Assignment (With possibility of extension)

A leading university seeks a Clinical Research Coordinator to coordinate clinical studies from start-up through closeout, including participant enrollment, data management, and regulatory compliance.

Clinical Research Coordinator Responsibilities:

• Coordinate moderately complex aspects of one or more clinical studies from start-up through closeout under close direction of the principal investigator and/or study coordinator/supervisor, serving as primary contact with research participants, sponsors, and regulatory agencies, and interacting regularly with the principal investigator to ensure patient safety and proper study conduct.
• Determine participant eligibility and gather consent according to protocol, assist in developing recruitment strategies, and coordinate the collection and processing of study specimens.
• Collect and manage patient and laboratory data, manage research project databases, develop flow sheets and other study-related documents, complete case report forms, and ensure essential documentation and recording of patient and research data in appropriate files per institutional and regulatory requirements.
• Ensure compliance with research protocols, review and audit case report forms for completion and accuracy against source documents, prepare regulatory submissions, ensure Institutional Review Board renewals are completed, and participate in monitor visits and regulatory audits.
• Assemble study kits for study visits, monitor scheduling of procedures and charges, coordinate documents, and attend monitoring meetings with sponsors as primary contact. Monitor expenditures and adherence to study budgets, resolving billing issues in collaboration with finance and/or management staff.

Clinical Research Coordinator Qualifications:

• 2 years of related work experience and a two-year college degree; OR
• Bachelor's degree in a related field; OR
• Equivalent combination of related education and relevant experience.
• Society of Clinical Research Associates (SOCRA) or Association of Clinical Research Professionals (ACRP) certification is preferred.
• Clinical research assistant and data entry experience.
• Experience working with electronic medical records.
• Knowledge of medical terminology and proficiency with Microsoft Office.
• Experience with EPIC is preferred.
• Ability to pull objects up to 40 pounds.

Shift:

• Hybrid: onsite 3-4 days/week. Day Shift.