Senior Clinical Research Associate

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

📋 Description

• Execute and coordinate activities related to clinical monitoring and site management.

• Conduct both remote and on-site visits to evaluate compliance with protocols and regulations.

• Oversee clinical trial documentation, procedures, and adherence to sponsor guidelines.

• Ensure that trials comply with approved protocols, ICH-GCP guidelines, regulations, and SOPs.

• Monitor investigator sites utilizing risk-based monitoring, including root cause analysis and corrective/preventive measures.

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

• Evaluate the inventory and records of investigational products.

• Document findings and escalate deficiencies until resolved.

• Maintain communication with investigative sites between monitoring visits.

• Carry out monitoring tasks in accordance with approved monitoring plans.

• Participate in the resolution of investigator payments and findings.

• Track the status of trials and provide progress updates to the Clinical Team Manager.

• Update and ensure quality checks for clinical trial management systems.

• Engage in investigator meetings and identify qualified investigators/sites.

• Initiate clinical trial sites and support compliance with regulatory and ICH-GCP standards.

• Close out trials and retrieve associated materials.

• Ensure all essential documents are complete and conduct both on-site and remote file reviews.

• Assist with project publications, tools, trip report reviews, newsletters, and CRA team meetings.

• Facilitate communication among investigative sites, clients, and the PPD project team.

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

• Complete expense reports and timesheets.

• Contribute to initiatives aimed at process improvement.

⛳️ Requirements

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

• A valid New Zealand driver's license and the ability to drive.

• Over 4 years of experience as a clinical research monitor or in a comparable role.

• Experience in monitoring phase-I healthy volunteer studies.

• Proficient clinical monitoring skills.

• Knowledge of medical/therapeutic areas and medical terminology.

• Understanding and application of ICH GCPs, relevant regulations, and procedural documents.

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

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

• Excellent oral and written communication skills.

• Ability to effectively communicate with medical professionals.

• Customer-oriented with strong listening skills, attention to detail, and the ability to identify underlying issues.

• Strong interpersonal, organizational, and time management skills.

• Flexibility and adaptability to changing circumstances.

• Ability to work independently as well as collaboratively in a team setting.

• Proficient in Microsoft Office and capable of learning relevant software.

• Strong English language and grammar skills.

• Competent presentation skills.

🏝️ Benefits

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

• Comprehensive Total Rewards package.

• Extensive health and wellbeing benefits.

• Wellness programs available.

• Employee Assistance Program.

• Flexible work arrangements.

• Generous leave policies.

• Option to purchase additional leave.

• Paid leave on birthdays.

• Company-paid parental leave.

• Paid time for volunteer activities.

• Access to Thermo Fisher Scientific University Plus online courses.

• Opportunities for LinkedIn Learning.

• Participation in workshops.

• Involvement in mentorship programs.