In-house Clinical Research Associate I

In-house Clinical Research Associate I (IHCRA) - Sydney or Melbourne

Fortrea is seeking an In-house Clinical Research Associate I (IHCRA I) to join a Clinical Project Team. The IHCRA I will contribute to the execution of a Clinical Research Project, with responsibilities reflecting their experience and contribution level. Work involves Clinical Operations activities in office or home-based settings for designated projects, with some travel for site visits or meetings. The IHCRA I will assist with ensuring data quality and integrity and other study-related activities in compliance with Company or Sponsor SOPs, regulatory standards, and applicable guidelines. The role includes completing the Fortrea Monitoring Excellence Academy (MEA) training program.

Summary of Responsibilities

• Serve as the contact for the project team and investigative sites; conduct site contacts and document contacts per study guidelines, including creating contact reports for each site interaction.
• Monitor site performance and implement action plans for sites not meeting expectations, in collaboration with the CRA.
• Assist CRAs with site visit readiness (e.g., running reports, QC of files, resolving action items from previous visits).
• Perform Case Report Form review, generate and resolve queries against data review guidelines on Fortrea or client data management systems, as assigned.
• Coordinate study visits and shipment of drug, ancillary supplies, and laboratory kits/samples.
• Manage sites to ensure subjects comply with the protocol, visits, and timelines.
• Distribute and track clinical trial supplies (e.g., CRFs, study medication, lab kits) to ensure sites have sufficient supplies to continue recruitment.
• liaise with Study Start-up and maintain activities after Site Activation (e.g., revisions of FDA Form 1572, medical license expiration, CVs, laboratory certificates, Protocol Signature Page, IRB submissions/renewals, PI changes).
• Work with sites and project teams to complete maintenance activities (amendments, revised documents) as applicable in the region.
• Demonstrate understanding of CTMS usage and enter weekly details as required.
• Collaborate with the CTA to assist the Project Team in producing Status Reports.
• Perform tasks within the study budget timeline under guidance of the Clinical Team Leader (CTL) and Project Manager.
• Assist with submissions and notifications to Ethics Committees and Regulatory Authorities as applicable in the region.

On-site vs Remote

• On-site: Support on-site activities with various CRA roles, review of Case Report Forms, Site Regulatory File, and drug accountability as required by training goals.
• Remote: Conduct remote visits (Phone PSVs, Phone SIVs, remote RMVs, remote COVs) as required by the monitoring plan; assist with document translation as needed; handle recruitment tracking and site document preparation; participate in client-facing activities as assigned; attend meetings and present as required; perform other project-related duties.

Qualifications (Minimum Required)

• University/college degree (life science preferred) or certification in a related allied health profession from an accredited institution (e.g., nursing certification, medical or laboratory technology).
• Alternatively, 2-3 years or more of relevant clinical research experience in pharmaceutical or CRO industries may be considered.

Experience (Minimum Required)

• At least one year of experience in a related field (e.g., medical, clinical, pharmaceutical, laboratory research, data analysis, data management, or technical writing); one year of clinical research experience is preferred.
• Basic understanding of biology and biological processes; ability to monitor study sites according to protocol monitoring guidelines, SOPs, ICH Guidelines, and GCP.
• Good organizational, time management, and communication skills (oral and written).
• Proficiency in general computer literacy; ability to work effectively in a matrix environment; fluency in the local official language and English (written and verbal).

Physical Demands / Work Environment

• General office environment with some travel required.

This role is for upcoming future opportunities that may arise at Fortrea. Learn more about our EEO & Accommodations request here.

Seniority level

• Entry level

Employment type

• Full-time

Job function

• Research, Analyst, and Information Technology

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