Contract Clinical Research Associate

Clinical Research Associate (CRA)

This position involves performing and coordinating all aspects of the clinical monitoring and site management process. The role requires conducting remote or on-site visits to assess protocol and regulatory compliance, managing required documentation, and ensuring that trials are conducted in accordance with approved protocols, ICH-GCP guidelines, and applicable regulations. The CRA will act as a site processes specialist, ensuring the rights and well-being of subjects and the reliability of data. The position also involves developing collaborative relationships with investigational sites and ensuring audit readiness.

Responsibilities include:

• Monitor investigator sites using a risk-based monitoring approach, applying root cause analysis, critical thinking, and problem-solving skills to identify and rectify site process failures.
• Ensure data accuracy through source data review, source document verification, and case report form review during on-site and remote monitoring activities.
• Assess investigational products through physical inventory and records review, documenting observations in reports and letters using approved business writing standards.
• Escalate observed deficiencies and issues to clinical management and ensure their resolution.
• Maintain regular contact with investigative sites to confirm protocol adherence and timely issue resolution.
• Conduct monitoring tasks in accordance with the approved monitoring plan and participate in the investigator payment process.
• Provide trial status tracking and progress update reports to the Clinical Team Manager.
• Ensure study systems are updated per agreed study conventions and perform quality control checks of reports generated from the Clinical Trial Management System.
• Participate in investigator meetings and identify potential investigators to ensure qualified investigative sites.
• Initiate clinical trial sites according to relevant procedures to ensure compliance with protocols and regulatory obligations.
• Ensure that required essential documents are complete and in place according to ICH-GCP and applicable regulations.
• Contribute to project team efforts by assisting in the preparation of project publications/tools and sharing ideas/suggestions.
• Facilitate effective communication between investigative sites, the client company, and the project team.
• Respond to company, client, and applicable regulatory requirements, audits, and inspections.
• Complete administrative tasks such as expense reports and timesheets promptly.
• Contribute to other project work and initiatives for process improvement as required.

Essential skills include:

• Bachelor's degree in a life sciences-related field or a Registered Nursing certification or equivalent formal academic qualification.
• Minimum of 2+ years of experience as a clinical research monitor.
• Valid driver's license where applicable.
• Effective clinical monitoring skills.
• Understanding of medical/therapeutic area knowledge and medical terminology.
• Strong grasp and application of ICH-GCPs, applicable regulations, and procedural documents.
• Well-developed critical thinking skills for in-depth investigation and root cause analysis.
• Ability to manage Risk Based Monitoring concepts and processes.
• Effective oral and written communication skills with medical personnel.
• Strong customer focus and attention to detail.
• Effective interpersonal skills and strong attention to detail.
• Good organizational and time management skills.
• Ability to work independently or within a team as required.
• Proficient computer skills, including knowledge of Microsoft Office and the ability to learn appropriate software.
• Good English language and grammar skills.

Additional skills and qualifications include:

• Experience in remote or on-site visits to assess protocol and regulatory compliance.
• Experience managing procedures and guidelines from different sponsors and monitoring environments.
• Experience developing collaborative relationships with investigational sites.
• Experience ensuring audit readiness.

Work environment is 100% home-based with 60-80% travel required.

This is a contract position based out of San Diego, CA, with a pay range of $70.00 - $95.00/hr. Benefits may include medical, dental & vision, critical illness, accident and hospital, 401(k) retirement plan, life insurance, short and long-term disability, health spending account (HSA), transportation benefits, employee assistance program, and time off/leave (PTO, vacation or sick leave).

Application deadline is anticipated to close on Oct 27, 2026. This is a fully remote position.