Clinical Research Associate I

This is a fully remote position, open to applicants in California, +1 more state.

📋 Description

• Provide support to clinical trial sites from the initiation phase through to the closeout phase.

• Ensure that studies adhere to protocols, regulatory standards, and company policies.

• Conduct visits for site qualification, initiation, monitoring, and closeout.

• Train and assist investigators, study coordinators, and site personnel.

• Oversee protocol compliance, data integrity, and adherence to Good Clinical Practice (GCP) standards.

• Examine source documents and validate clinical study data for accuracy and completeness.

• Guarantee that only eligible participants are enrolled in the studies.

• Manage and maintain all study-related and regulatory documentation.

• Supervise investigational product accountability and inventory management.

• Review adverse event reports to ensure accuracy and compliance.

• Evaluate site performance, focusing on patient recruitment and retention rates.

• Prepare monitoring reports and communicate findings, risks, and necessary corrective actions.

• Cultivate strong relationships with clinical research sites and internal stakeholders.

• Expand knowledge of relevant clinical research regulations and various study types.

• Collaborate with Clinical Project Teams and Operations leadership under the Clinical Manager's guidance.

⛳️ Requirements

• A Bachelor's degree in life sciences or clinical research is preferred, or a comparable combination of education and experience.

• A minimum of 1 year of experience in clinical research.

• Strong attention to detail and effective time management skills.

• Exceptional written and verbal communication, organizational, and presentation abilities.

• Capability to work collaboratively with others.

• Self-motivated and able to thrive in a fast-paced, ever-changing environment.

• Ability to multitask, prioritize tasks, and manage time efficiently.

• Proficient in computer applications, including Microsoft Office Suite (Word, Excel, Outlook, etc.).

• Willingness to travel; initially 40% travel with potential increase to 50% later.

• Ability to work with human blood, potentially infectious materials, and infectious organisms.

• Capacity to lift, carry, push, or pull more than 20 pounds (9 kilos) regularly or daily.

🏝️ Benefits

• Opportunities for career development within an international company.

• Complimentary medical coverage through the Health Investment Plan (HIP) PPO medical plan for qualifying employees.

• Retirement savings plan featuring a substantial employer contribution.

• Tuition reimbursement for further education.

• Freedom 2 Save program to assist with student debt.

• FreeU education benefit supporting pursuit of a bachelor’s degree.

• A variety of diverse career opportunities.

• Comprehensive health and wellness benefits.