Experienced Clinical Research Associate – CRA II, SR CRA

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 compliance with protocols and regulations.

• Manage sponsor procedures and guidelines across various monitoring settings.

• Ensure that trials adhere to approved protocols, ICH-GCP guidelines, relevant regulations, and SOPs.

• Maintain audit readiness and foster collaborative relationships with investigational sites.

• Monitor investigator sites utilizing a risk-based monitoring strategy.

• Apply root cause analysis to detect site process failures and implement corrective and preventive measures.

• Guarantee data accuracy through the review of source documents, source data verification, and CRF review.

• Evaluate investigational products through physical inventory and record assessments.

• Document findings in reports and letters, and escalate deficiencies to clinical management.

• Stay in contact with investigative sites between monitoring visits and follow up on any issues.

• Engage in investigator payment processes and resolution of findings.

• Participate in investigator meetings.

• Identify prospective investigators and initiate clinical trial sites.

• Conduct trial closeouts and retrieve trial materials.

• Ensure that essential documents are complete and perform on-site file reviews.

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

• Update study systems like Clinical Trial Management Systems.

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

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

• Complete expense reports and timesheets.

• Assist with project publications and tools.

• Contribute to project work and process improvement initiatives.

⛳️ Requirements

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

• Previous experience that equips the knowledge, skills, and abilities to perform the role, comparable to 1 year as a clinical research monitor, or completion of the PPD Drug Development Fellowship.

• Equivalency combining appropriate education, training, and/or directly related experience may be considered.

• Valid driver's license where applicable.

• Demonstrated clinical monitoring skills.

• Understanding of medical/therapeutic area knowledge and medical terminology.

• Working knowledge of ICH GCPs, applicable regulations, and procedural documents.

• Strong critical thinking, root cause analysis, and problem-solving skills.

• Ability to manage Risk-Based Monitoring concepts and processes.

• Excellent oral and written communication abilities.

• Strong organizational and time management skills.

• Effective interpersonal skills and attention to detail.

• Flexibility and adaptability.

• Ability to work independently or as part of a team.

• Proficient knowledge of Microsoft Office and capability to learn relevant software.

• Strong English language and grammar skills.

• Good presentation skills.

• Willingness to travel frequently, generally 60–80%, with up to 75% regional travel and potential extended overnight stays.

• Capacity to work in office, laboratory, clinical, and/or home office environments.

• Ability to utilize necessary personal protective equipment.

🏝️ Benefits

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

• Selection of national medical and dental plans.

• National vision plan, which includes health incentive programs.

• Employee assistance and family support programs.

• Commuter benefits.

• Tuition reimbursement.

• Minimum of 120 hours 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.

• Short- and long-term disability coverage.

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

• Employees’ Stock Purchase Plan (ESPP), allowing eligible colleagues to purchase company stock at a discount.