Clinical Research Associate

Role overview

This part-time Clinical Research Associate opportunity is a 12-month contract with the possibility of extension. The position is based in Irvine, CA, and can be performed fully remotely from anywhere in the United States. The schedule starts at about 30 to 35 hours per week for the first 4 to 5 months and then settles to roughly 25 hours per week. Some domestic travel is required for 1 to 2 site visits per month.

Purpose of the role

The main objective of this position is to make sure clinical studies are run and documented in line with all relevant regulatory standards.

Key responsibilities

• Provide operational support across the study lifecycle by reviewing data and document gaps, then helping improve processes so similar issues do not repeat during study conduct or closeout.
• Coordinate study start-up tasks, including monitoring site readiness, handling essential document collection, and keeping sites informed about planning and logistics for Site Qualification Visits (SQVs) and Site Initiation Visits (SIVs).
• Carry out remote monitoring activities for qualification, initiation, interim, and close-out visits, and prepare visit reports according to the monitoring plan.
• Work closely with site teams, IRBs/ECs, vendors, contractors, and internal cross-functional partners.
• Develop and sustain effective working relationships with internal groups such as Clinical Operations, Regulatory Affairs, Quality, and R&D, as well as site staff including investigators, CRCs, and research nurses, to support enrollment, data quality, and site performance.
• Support site remediation efforts when needed.
• Complete all required global Medical and Clinical Affairs, business-unit-specific, and study-specific training and keep it current.
• Identify ways to improve efficiency and suggest practical solutions within related functional areas.

Required background

• A bachelor’s degree or equivalent in Life Sciences or Nursing is required.
• At least 3 to 4 years of experience in clinical research as either a CRC or CRA, including quality assurance/control and regulatory compliance experience in the healthcare sector.
• Hands-on experience with electronic data capture systems.

Preferred qualifications

• Clinical research certification such as ACRP or SoCRA, or certification as a clinical coordinator/CRA, is preferred.

Additional details

This role references experience with Viva or a similar platform. The position also includes domestic travel for 1 to 2 site visits each month.

EEO statement

Mindlance is an equal opportunity employer and does not discriminate in employment based on minority status, gender, disability, religion, LGBTQI status, age, or veteran status.