Senior Clinical Research Associate I

This is a fully remote position, open to applicants in California.

📋 Description

• Oversee and coordinate all facets of clinical monitoring and site management.

• Conduct both remote and on-site visits to evaluate adherence to protocols and regulatory standards.

• Manage essential clinical trial documentation and ensure preparedness for audits.

• Utilize a risk-based monitoring strategy to oversee investigator sites.

• Implement root cause analysis, critical thinking, and problem-solving techniques to pinpoint site process failures and devise corrective/preventive actions.

• Ensure data integrity through structured data review (SDR), source data verification (SDV), and case report form (CRF) assessments.

• Evaluate investigational products via inventory checks and records analysis.

• Record observations in comprehensive reports and correspondence.

• Report deficiencies and challenges to clinical management and ensure their resolution.

• Maintain consistent communication with investigative sites during intervals between monitoring visits.

• Execute monitoring responsibilities as outlined in the approved monitoring plan.

• Engage in investigator payment procedures and meetings.

• Provide trial status updates and progress reports to the Clinical Team Manager.

• Revise clinical trial management systems and conduct necessary quality checks on CTMS reports.

• Identify prospective investigators and initiate clinical trial sites.

• Ensure trial closeout, retrieval of trial materials, and completion of requisite documentation.

• Perform on-site file reviews.

• Contribute to project publications, tools, process enhancements, and various project initiatives.

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

• Address company, client, and regulatory demands, including audits and inspections.

• Complete administrative responsibilities, such as expense reporting and timesheet submissions.

⛳️ Requirements

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

• Prior experience of at least 3 years in a related role.

• Oncology experience is preferred.

• Strong critical thinking and problem-solving abilities.

• Exceptional skills in clinical trial monitoring, both remotely and on-site.

• Comprehension of ICH-GCP guidelines, relevant regulations, and standard operating procedures (SOPs).

• Proficient communication and collaboration skills.

• Capability to represent the client while fostering professional relationships.

• Advanced verbal and written communication abilities.

• Strong organizational aptitude and meticulous attention to detail.

• Proven experience with computer systems, including CTMS and other trial management platforms.

• Willingness to travel over 75% as necessitated for site monitoring tasks.

🏝️ Benefits

• Variable annual bonus based on performance outcomes at the company, team, and/or individual levels.

• National medical and dental insurance plans.

• National vision coverage, including health incentive programs.

• Employee assistance and family support services.

• Commuter benefits.

• Tuition reimbursement program.

• 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-term and long-term disability insurance.

• 401(k) retirement savings plan in the U.S.

• Employees’ Stock Purchase Plan (ESPP) offering the opportunity to buy company stock at a discount.