Clinical Research Associate I

This is a fully remote position, open to applicants in California, +3 more states.

📋 Description

• Oversee investigator sites utilizing a risk-based monitoring strategy, which includes root cause analysis, problem-solving, site data review (SDR), source data verification (SDV), case report form (CRF) examination, investigational product evaluation, and implementing corrective and preventive measures.

• Record findings in reports and correspondence, escalate deficiencies, and ensure issues are resolved.

• Maintain ongoing communication with investigative sites between monitoring visits to verify adherence to protocols, resolve issues, and ensure timely data entry.

• Execute monitoring activities in accordance with the approved monitoring plan and engage in investigator payment processes.

• Participate in investigator meetings and assist in identifying qualified investigators and suitable investigative sites.

• Initiate clinical trial sites, perform trial closures, and retrieve trial materials.

• Ensure that essential documents are complete and compliant with ICH-GCP and relevant regulations.

• Conduct on-site file reviews per project specifications.

• Monitor trial status and provide updates on progress; maintain accurate and comprehensive study systems such as the Clinical Trial Management System.

• Facilitate communication among investigative sites, the client company, and internal project teams.

• Address company, client, and regulatory requirements, as well as audits and inspections.

• Complete expense reports and timesheets.

• Support project publications and tools, offer suggestions, and contribute to initiatives aimed at process improvement.

⛳️ Requirements

• Bachelor’s degree in a life sciences field, or Registered Nursing certification, or another equivalent relevant academic/vocational qualification.

• A minimum of clinical monitoring experience equivalent to 2 years in a clinical setting involving clinical trials, medical terminology, medical research, clinical research, or healthcare.

• Alternatively, experience in a health sciences discipline with formal training in medical terminology and anatomy may be accepted.

• Valid driver’s license where necessary.

• Must be legally authorized to work in the United States without the need for sponsorship.

• Must successfully complete a comprehensive background check, including drug screening.

• Candidates are preferred to reside within 60 miles of a major airport hub.

• Basic knowledge of medical/therapeutic areas and medical terminology.

• Ability to acquire and maintain a working knowledge of ICH GCPs, relevant regulations, and procedural documents.

• Strong verbal and written communication skills with the capacity to effectively interact with medical personnel.

• Good interpersonal, organizational, and time-management abilities.

• Skills in critical thinking, root cause analysis, and problem-solving.

• Capacity to manage risk-based monitoring concepts and processes.

• Ability to work independently or collaboratively in a team environment.

• Proficient in Microsoft Office and willing to learn necessary software.

• Solid English language proficiency and grammar skills.

• Willingness to travel frequently, typically 60–80%, including potential extended overnight stays.

• Ability to work in environments with possible exposure to biological fluids and infectious agents, utilizing required personal protective equipment.

🏝️ Benefits

• Variable annual bonus based on individual, team, and/or company performance results.

• Selection of national medical and dental plans.

• National vision plan, inclusive of health incentive programs.

• Employee assistance and family support initiatives.

• Commuter benefits.

• Tuition reimbursement.

• A minimum of 120 hours of paid time off (PTO).

• 10 paid holidays each year.

• Paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave).

• Accident and life insurance coverage.

• Short- and long-term disability benefits in line with company policy.

• Competitive 401(k) U.S. retirement savings plan.

• Employees' Stock Purchase Plan (ESPP), allowing eligible colleagues to buy company stock at a discounted rate.