Senior Clinical Research Associate – FSP

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

📋 Description

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

• Execute remote or on-site assessments to ensure adherence to protocols and regulatory standards.

• Administer necessary documentation as well as sponsor and monitoring environment procedures and guidelines.

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

• Maintain audit readiness and cultivate relationships with investigational sites.

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

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

• Validate data accuracy through SDR, SDV, and CRF reviews during both on-site and remote monitoring.

• Evaluate investigational products through physical inventory checks and records review.

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

• Raise deficiencies and issues to clinical management and ensure resolution.

• Maintain communication with investigative sites between monitoring visits.

• Execute monitoring tasks in alignment with the approved monitoring plan.

• Engage in the investigator payment process.

• Investigate and follow up on findings.

• Provide status tracking and progress updates regarding trials to the Clinical Team Manager.

• Update study systems, including CTMS, and carry out essential CTMS report quality-control checks.

• Participate in investigator meetings.

• Identify potential investigators for the client company.

• Initiate clinical trial sites and offer compliance recommendations.

• Ensure trial closeout and retrieval of trial materials.

• Confirm that essential documents are complete and properly filed; conduct on-site file reviews.

• Contribute to project publications, tools, and process-improvement initiatives.

• Undertake additional study tasks as assigned by the CTM.

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

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

• Complete expense reports and timesheets.

• Engage in frequent travel to site locations, typically 60–80% or more.

⛳️ Requirements

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

• Valid driver's license where applicable.

• A minimum of 3 years of experience as a clinical research monitor, or comparable experience that provides the necessary knowledge, skills, and abilities.

• Equivalency may be considered through a combination of relevant education, training, and/or directly related experience.

• Proficient clinical monitoring skills.

• Familiarity with medical/therapeutic area knowledge and medical terminology.

• Knowledge and practical application of ICH GCPs, applicable regulations, and procedural documents.

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

• Capability to manage Risk Based Monitoring concepts and processes.

• Effective oral and written communication skills with medical personnel.

• Customer-focused with good listening skills, attention to detail, and the ability to recognize underlying customer issues.

• Strong interpersonal skills.

• Excellent attention to detail.

• Ability to comply with specific sponsor/client/site requirements, including the disclosure of vaccination status or other personal information.

🏝️ Benefits

• Comprehensive health and wellness benefits.

• Wellness programs.

• Employee Assistance Program that offers confidential support for personal and work-related matters.

• Flexible work arrangements.

• Generous leave policies.

• Option to purchase additional leave days.

• Paid leave on your birthday.

• Company-paid parental leave.

• Paid time off for volunteering.

• Access to online courses through Thermo Fisher Scientific University Plus and LinkedIn Learning.

• Workshops and mentorship opportunities.

• Recognized by WGEA as an Employer of Choice for Gender Equality.