Senior Clinical Research Associate

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

📋 Description

• Oversee and coordinate all facets of clinical monitoring and site management for a designated client.

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

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

• Ensure data integrity through SDR, SDV, and CRF evaluations during both on-site and remote monitoring.

• Review the investigational product by conducting physical inventory and records assessments.

• Record observations in reports and letters adhering to established business writing standards.

• Raise deficiencies and issues to clinical management and ensure follow-through until resolution.

• Maintain consistent communication with investigative sites between monitoring visits.

• Execute monitoring activities in accordance with the approved monitoring plan.

• Engage in investigator payments and participate in investigator meetings.

• Monitor trial status and deliver progress updates to the Clinical Trial Manager.

• Update study systems, including CTMS, and perform necessary quality checks on CTMS reports.

• Identify potential investigators and initiate clinical trial sites.

• Ensure trial closeout, recovery of materials, and completion of essential documentation.

• Conduct on-site file reviews.

• Contribute to project publications, tools, process enhancements, and other designated study responsibilities.

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

• Address company, client, and regulatory requirements, along with audits and inspections.

• Fulfill administrative duties such as submitting expense reports and completing timesheets.

⛳️ Requirements

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

• More than 3 years of relevant experience.

• Oncology experience is preferred.

• Strong critical thinking and problem-solving capabilities.

• Excellent skills in remote and on-site clinical trial monitoring.

• Familiarity with ICH-GCP guidelines, applicable regulations, and SOPs.

• Proficient in evaluating data and addressing various issues.

• Good judgment in selecting appropriate methods and techniques for solutions.

• Strong communication and collaboration abilities.

• Capacity to interact effectively with investigative sites, clients, and internal teams.

• Ability to represent the client while fostering professional relationships.

• Advanced skills in both written and oral communication.

• Strong organizational capabilities and attention to detail.

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

• Willingness to travel over 75% for site monitoring activities.

🏝️ Benefits

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

• Options for national medical and dental insurance plans.

• National vision plan, inclusive of health incentive programs.

• Employee assistance and family support programs.

• 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.

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

• Employees’ Stock Purchase Plan (ESPP) offering the chance to acquire company stock at a discounted rate.