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Clinical Research Associate (Contractor)

Freenome

Brisbane, CARemoteFull-timeNo compensation foundPosted 5mo agoVerified open 3 days ago

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At a glance

Compensation
No compensation found
Location
Brisbane, CARemote
Schedule
Full-time
Work Authorization
Not specified

Requirements

Credentials this posting asks for.

Security clearanceBachelor's degree

Job overview

Freenome is hiring a Clinical Research Associate (Contractor). Freenome seeks a contract Clinical Research Associate to support its Clinical Development team, focusing on diagnostics clinical trial management. The remote role involves overseeing site monitoring, ensuring protocol compliance, and contributing to cancer early detection research, reporting to the Director of Clinical Operations.

Key focus areas include Ensure compliance with protocol, regulatory and ICH GCP obligations during site monitoring activities, Conduct on‑site and remote monitoring, including source document verification per the Clinical Monitoring Plan, and Write and submit investigational site findings reports and update tracking systems, escalating deficiencies as needed.

Successful candidates bring Bachelor's Degree In Life Science‑Related Field, Registered Nurse (RN) Certification, and 3+ Years Clinical Trials Research Experience. Important skills include Diagnostics Clinical Trial Management, Clinical Research, Attention To Detail, Good Clinical Practice, Regulatory Requirements, and ICH GCP Obligations. Preferred (not required): Cancer Early Detection, Cancer Early Detection Space, Well-Organized, and Excellent Communicator.

Skills & qualifications

RequiredNice to have

Skills

Diagnostics Clinical Trial ManagementClinical ResearchAttention to DetailGood Clinical PracticeRegulatory RequirementsICH GCP ObligationsMulti-TaskingShifting Priorities ManagementProactive Problem SolvingRisk ManagementInterpersonal SkillsCollaborationTime ManagementOrganizational SkillsVeeva VaultMedrioSpoken CommunicationCommunicationCancer Early DetectionShifting PrioritiesInterpersonalCollaborativeCancer Early Detection SpaceClinical Site MonitoringSite InitiationRoutine MonitoringMaintenance of Study FilesStudy Close OutRetrieval of Study MaterialsSource Document VerificationMulti-TaskDeal With Shifting PrioritiesProactively Solve ProblemsManage RisksStrong InterpersonalAccurateDetail-OrientedStrong Spoken CommunicationStrong Written CommunicationICH GCPWell-OrganizedExcellent CommunicatorClinical Trial MonitoringSite ManagementRegulatory ComplianceOn-Site MonitoringRemote MonitoringInvestigational Site Findings ReportingTracking Systems UpdatingProblem SolvingInterpersonal CommunicationCollaborative SkillsDetail OrientationCommunication SkillsInterpersonal AbilitiesRegulatory Requirements KnowledgeIn Vitro Diagnostics Study ExperienceIn Vitro DiagnosticsIn Vitro Diagnostics KnowledgeStrong Communication SkillsCollaborative AbilitiesSite MonitoringClinical Monitoring PlanSpoken and Written CommunicationRegulatory KnowledgeClinical Monitoring Plan KnowledgeReport WritingStrong Spoken and Written Communication

Qualifications

Bachelor's Degree in Life Sciences or Registered Nurse Certification or Equivalent3+ Years Clinical Trials Research ExperienceIn Vitro Diagnostics Study ExperienceCRA CertificationCancer Early Detection Experience

Full job description

About this opportunity:

At Freenome, we are seeking a Contract Clinical Research Associate to help grow the Freenome Clinical Development team. The ideal candidate is well-organized, an excellent communicator and experienced in diagnostics clinical trial management. This person is responsible for all things related to assigned aspects of clinical trial monitoring and site management. You are passionate about clinical research, attention to detail and Good Clinical Practice, and you will have a significant impact on the continued growth of an organization dedicated to changing the entire landscape of cancer.

The role reports to the Director of Clinical Operations, Dennis McHugh. This role will be a Remote role with occasional travel, as required, to our Brisbane, California headquarters.

What you’ll do:

  • Ensure compliance with standard protocol and regulatory and ICH GCP obligations in assigned aspects of clinical site monitoring, such as site initiation, routine monitoring, maintenance of study files, study close out, and retrieval of study materials.
  • Complete on-site and remote monitoring activities in compliance with the Clinical Monitoring Plan, including source document verification for accuracy and integrity, as required.
  • Write and submit reports of investigational site findings and update applicable tracking systems, as required; escalate observed deficiencies and issues as appropriate.

Must haves:

  • Minimum Bachelor’s degree in a life science-related field, a registered nurse (RN) certification, or equivalent.
  • 3+ years’ experience in a clinical trials research environment required, with specific in vitro diagnostics study experience.
  • General knowledge of regulatory requirements & GCP.
  • Ability to multi-task, deal with shifting priorities, and proactively solve problems/manage risks.
  • Strong interpersonal, collaborative, and time management abilities.
  • Excellent organizational skills; accurate and detail-oriented.
  • High proficiency in Veeva Vault and Medrio.
  • Strong spoken and written communication skills.

Nice to haves:

  • CRA certification by recognized professional organization is a plus, but not mandatory.
  • Previous experience in the cancer early detection space.

Additional information:

Contractors may be hired through a third-party provider and will be considered contingent workers. We invite you to check out our career page @ freenome.com/job-openings/ for additional company information.

Freenome is proud to be an equal opportunity employer and we value diversity. Freenome does not discriminate on the basis of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law.

Applicants have rights under Federal Employment Laws.

California applicants please review the CCPA Notice at Collection here:

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