Job Overview:

The Senior CRA I is responsible for site monitoring and site management. Responsibility for clinical studies according to Fortrea, and/or Sponsor, Standard Operating Procedures, and Regulatory Guidelines. The Senior CRA I assure the implementation of project plans, as assigned. Function as leader for projects of limited scope, as assigned. Assume line management responsibilities, as assigned. Act in the project role of a Local Project Coordinator or Lead CRA as assigned.

Summary of Responsibilities:

• Responsible for all aspects of study site monitoring including routine monitoring and closeout of clinical sites, maintenance of study files, conduct of pre-study and initiation visits
• Liaise with vendors
• And other duties, as assigned
• Responsible for all aspects of site management as prescribed in the project plans.

General On-Site Monitoring Responsibilities:

• Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study.
• Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements.
• Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review.
• Monitor data for missing or implausible data.
• Ensure the resources of the Sponsor and Fortrea are spent wisely by performing the required monitoring tasks in an efficient manner, according to SOPs and established guidelines, including managing travel expenses in an economical fashion according to Fortrea travel policy.
• Ensure audit readiness at the site level.
• Travel, including air travel, may be required and is an essential function of the job.
• Prepare accurate and timely trip reports.
• Manage small projects under the direction of a Project Manager/Director as assigned.
• Serve as lead monitor for a protocol or project and may assist in establishing monitoring plans and trip report review as assigned.
• Review progress of projects and initiate appropriate actions to achieve target objectives.
• Organize and make presentations at Investigator Meetings.
• Participate in the development of protocols and Case Report Forms as assigned.
• Participate in writing clinical trial reports as assigned.
• Interact with internal work groups to evaluate needs, resources, and timelines.
• Act as contact for clinical trial supplies and other suppliers (vendors) as assigned.
• Responsible for all aspects of registry management as prescribed in the project plans.
• Undertake feasibility work when requested.
• Conduct, report, and follow-up on Quality Control (QC) visits when requested.
• Recruitment of potential investigators, preparation of EC submissions, notifications to regulatory authorities, translation of study-related documentation, organization of meetings and other tasks as instructed by supervisor as assigned.
• Negotiate study budgets with potential investigators and assist the Fortrea legal department with statements of agreements as assigned.
• Track and follow-up on Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs.
• Independently perform CRF review; query generation and resolution against established data review guidelines on Fortrea or client data management systems as assigned by management.
• Assist with training, mentoring and development of new employees, e.g., co-monitoring.
• Coordinate designated clinical projects as a Local Project Coordinator (with supervision, if applicable), and may act as a local client contact as assigned 29) Perform other duties as assigned by management.
• All other duties as needed or assigned.

Qualifications (Minimum Required):

• University or college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution, nursing certification, medical or laboratory technology.
• In lieu of the above education requirement, candidates with a minimum of 3 years relevant clinical research experience in pharmaceutical or CRO industries will be considered.
• Thorough knowledge of regulatory requirements including a basic understanding of regulatory requirements in other countries.
• Thorough understanding of the drug development process.
• Fluent in local office language and in English, both written and verbal.
• Fortrea may consider relevant and equivalent experience in lieu of educational requirements.

Experience (Minimum Required):

• Three (3) years of Clinical Monitoring experience.
• Have a full understanding of Serious Adverse Event (SAE) reporting, process production on reports, narratives and follow up of SAEs.
• Advanced site monitoring skills.
• Advanced study site management skills.
• Advanced registry administration skills.
• Ability to work with minimal supervision.
• Good planning and organization skills.
• Good computer skills with good working knowledge of a range of computer packages.
• Advanced verbal and written communication skills.
• Ability to train and supervise junior staff.
• Ability to resolve project-related problems and prioritizes workload for self and team.
• Ability to work within a project team.
• Works efficiently and effectively in a matrix environment.
• Valid Driver's License.

Preferred Qualifications Include:

• One (1) or more year's additional experience in a related field (i.e. medical, clinical, pharmaceutical, laboratory, research, data analysis, data management or technical writing) is preferred.
• Local project coordination and/or project management experience.

Physical Demands/Work Environment:

Travel requirements: 60-80% overnight.

At Fortrea, we're all about turning the "impossible" into "I'm possible." Together, we break barriers to deliver exceptional service to our patients, fueled by a shared commitment to teamwork and excellence. Regardless of your role, we're all family, working together to achieve extraordinary results. At Fortrea, your career isn't just a job - it's a journey of making the exceptional possible, every day.

Fortrea Australia Pty Ltd is seeking a Senior CRA I to oversee site monitoring and site management across clinical studies. You will implement project plans, lead projects of limited scope, and may assume Local Project Coordinator responsibilities as assigned.

You will monitor study sites, liaise with vendors, and ensure regulatory and data integrity requirements are met. Travel 60-80% may be required in this role.

Fortrea Australia Pty Ltd in Sydney seeks an experienced Lead CRA to manage clinical site monitoring in line with ICH GCP and Fortrea SOPs. You will oversee Pre-study, Site Initiation, and monitoring visits, ensuring patient safety and data integrity.

The role requires a university degree or nursing licensure, strong English proficiency, independence, and travel up to 60%. Collaboration with sponsors and staff training support are part of the duties.

We're excited to announce a new opportunity to join our growing team in Australia! We are currently seeking a Clinical Research Associate II (CRA2) who is passionate about advancing clinical research and making a meaningful impact in healthcare. As a CRA2, you will play a key role in managing and monitoring clinical trials, ensuring compliance with regulatory requirements, and fostering strong relationships with investigative sites. This is a fantastic opportunity for professionals looking to grow their career in a dynamic and collaborative environment.

Summary of Responsibilities

Site management responsibility for clinical studies according to Fortrea's Standard Operating Procedures, ICH GCP Guidelines, applicable project plans and Sponsor requirements, including verification of study training records. Conducts site monitoring responsibilities for clinical trials according to Fortrea's Standard Operating Procedures (SOPs), ICH guidelines and GCP; including Pre-study, Site Initiation, Process Monitoring, Routine Monitoring, and Close-out Visits. Prepares and implements project plans related to Clinical Monitoring responsibilities. Ensures the protection of subjects by verifying that informed consent procedures and protocol requirements are adhered to alongside applicable regulatory requirements. Safeguards data integrity by careful source document review, source document verification, query generation, and resolution against established data review guidelines on Fortrea or client data management systems. Confirms Site Regulatory documents and applicable eTMF/Sponsor Documents are complete and current throughout the duration of the trial. Guarantees that the study Investigational Product inventory and accountability is accurate and that study materials are stored securely and per protocol requirements. Ensures adherence to global quality control and CRA performance metrics. Ensures audit readiness at site level. Acts in the project role of a Lead CRA as assigned.

General On-Site Monitoring Responsibilities

Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter subjects/patients into the study. Ensure the protection of study subjects or patients by performing eligibility review, verifying that screening, informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements. Ensure the integrity of the source data reported by careful source document review. Monitor data for missing or implausible data. Ensure study data completeness, accuracy, consistency, and compliance; identify deficiencies, deviations and discrepancies, and initiate corrective action as required. Ensure the resources of the Sponsor and Fortrea are spent wisely by performing the required monitoring tasks in an efficient manner, according to SOPs and established guidelines, including managing travel expenses in an economical fashion according to Fortrea travel policy. Travel, including air travel, may be required and is an essential function of the job. Prepare and submit accurate and timely trip reports. Independently perform eCRF review, 100% source data verification, query generation and resolution against established data review guideline with or without direct supervision, on Fortrea or client data management systems, as assigned by management. Assist with the administration of clinical research projects, recruiting investigators (if applicable), collecting investigator documentation and site management. Update, navigate, and maintain Fortrea or study/Sponsor-specific trial management tools/eClinical systems. Track IP shipments and supplies, as needed. Track and follow-up on serious adverse events as assigned. Work closely with the study team, align monitoring to critical study timelines ensuring study deliverables are met. Prepare and implement study-specific monitoring plans and site Initiation slides, as assigned. Attend investigators' meetings (if applicable), project team meetings and teleconferences, and others as needed. Present training content for site initiation. Assist with training of new employees (e.g., co-monitoring). All other duties as needed or assigned.

Qualifications (Minimum Required)

University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure). An equivalent amount of experience can be substituted as appropriate. Thorough understanding of ICH GCP Guidelines and understanding of local regulatory requirements. Thorough knowledge of monitoring procedures. Basic understanding of the clinical trial process. Fluent in local office language and in English, both written and verbal. Fortrea may consider relevant and equivalent experience in lieu of educational requirements.

Experience (Minimum Required)

University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure). AND Typically 2 years of onsite clinical site monitoring experience (SIV - Close out). Ability to monitor study sites independently according to monitoring plan, project requirements, SOPs, and ICH GCP guidelines. Ability to work with minimal supervision. Have an understanding of the Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs. Good planning, organization, and problem-solving abilities. Works efficiently and effectively in a matrix environment.

Physical Demands/Work Environment

Location: Incumbent of the role needs to be based in Sydney hand happy to work 3 days from the office if not travelling Will involve outside of normal office hours as required by the role. Travel Requirement is 60% of the time (traveling to study sites). Learn more about our EEO & Accommodations request here.

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At Fortrea, we're all about turning the "impossible" into "I'm possible." Together, we break barriers to deliver exceptional service to our patients, fueled by a shared commitment to teamwork and excellence. Regardless of your role, we're all family, working together to achieve extraordinary results. At Fortrea, your career isn't just a job - it's a journey of making the exceptional possible, every day.

Fortrea Australia Pty Ltd is seeking a Clinical Research Associate II to manage and monitor clinical trials, ensuring regulatory compliance and robust site engagement. The role is based in Sydney with travel to study sites up to 60% of the time.

You will lead monitoring visits, verify source data, manage IP inventory, and maintain essential regulatory documents while collaborating with the study team to meet timelines and quality standards.

Fortrea Australia Pty Ltd is seeking a Senior Clinical Research Associate I to lead and monitor clinical trial sites across Australia. You will oversee initiation, visits, and closeout activities while ensuring patient safety and data integrity in accordance with regulatory standards.

You will review source documents, generate monitoring reports, and mentor junior staff. The role requires strong communication, organizational skills, and the ability to travel 60-80% to sites nationwide.

At Fortrea, we are redefining the clinical research landscape through innovation, collaboration, and a commitment to improving health worldwide. Join a global team where your expertise drives meaningful impact, and your career growth is supported every step of the way.

About the Role

As a Senior Clinical Research Associate I, you will play a pivotal role in ensuring the success of clinical trials by managing and monitoring study sites. You'll work closely with investigators and sponsors to uphold regulatory standards and deliver high-quality data that advances medical breakthroughs.

Key Responsibilities

• Monitor and manage clinical study sites, including initiation, routine visits, and closeout activities.
• Ensure patient safety and compliance with informed consent and protocol requirements.
• Review source documents and verify data integrity on Case Report Forms (CRFs).
• Prepare accurate and timely monitoring reports and maintain study files.
• Serve as lead monitor for assigned protocols and assist in developing monitoring plans.
• Coordinate with vendors and internal teams to meet project timelines and objectives.
• Support feasibility assessments, budget negotiations, and regulatory submissions.
• Mentor and train junior team members through co-monitoring and guidance.
• Travel extensively (60-80%) to support site activities and maintain audit readiness.

Qualifications

• Bachelor's degree in life sciences or related field, or equivalent clinical research experience.
• Typically a minimum of 3 years clinical onsite monitoring experience in pharmaceutical or CRO settings.
• Strong knowledge of regulatory requirements and drug development processes.
• Advanced site management skills.
• Excellent communication, organizational, and problem-solving abilities.
• Proficiency in relevant computer applications and systems.
• Valid driver's license and ability to travel extensively.
• Have the rights to work in Australia.
• Sorry, no visa sponsorship support offered at this time.

Why Join Fortrea?

• Global Impact: Contribute to groundbreaking research that improves lives worldwide.
• Career Development: Access robust training, mentorship, and advancement opportunities.
• Flexibility & Support: Thrive in a collaborative, inclusive environment that values work-life balance.
• Innovation: Be part of a forward-thinking organization shaping the future of clinical trials.

Fortrea is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

Learn more about our EEO & Accommodations request here.

At Fortrea, we're all about turning the "impossible" into "I'm possible." Together, we break barriers to deliver exceptional service to our patients, fueled by a shared commitment to teamwork and excellence.

Regardless of your role, we're all family, working together to achieve extraordinary results.

At Fortrea, your career isn't just a job - it's a journey of making the exceptional possible, every day.