Clinical Research Associate II - FSP

Fortrea Australia Pty Ltd; Kuala Lumpur; On-site; MYR 120,000 - 180,000; Full time

Job summary

Fortrea Australia Pty Ltd seeks a Lead Clinical Research Associate to manage site operations and monitoring of clinical studies in line with Fortrea SOPs, ICH GCP guidelines and Sponsor requirements.

Responsibilities include pre-study planning, initiation visits, routine monitoring, data verification, regulatory documents, IP tracking, and staff training. Travel up to 60% is required; based in Kuala Lumpur or Selangor and fluent in English and the local language.

Qualifications

• University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure).
• Minimum of 2 years of independent clinical monitoring experience.
• Experience supporting study sites from initiation to close-out.
• Thorough understanding of ICH GCP Guidelines and understanding of local regulatory requirements.
• Thorough knowledge of monitoring procedures.
• Fluent in local office language and in English, both written and verbal.
• Must be based in either Kuala Lumpur or Selangor.

Responsibilities

• Oversee site management and monitoring of clinical studies per Fortrea SOPs and ICH GCP.
• Conduct Pre-study, Site Initiation, Process Monitoring, Routine Monitoring, and Close-out Visits.
• Ensure informed consent and protocol adherence; regulatory compliance.
• Verify source data, manage data quality and query resolution.
• Maintain site regulatory documents and eTMF/Sponsor documents.
• Track Investigational Product inventory and site materials.
• Ensure audit readiness and support CRA performance metrics.
• Travel 60% to study sites as required.

Skills

Clinical Monitoring

ICH GCP Knowledge

SOP Adherence

Data Review & eCRF

Travel Readiness

Training & Mentoring

Education

Health profession degree

Job description

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.

Experience (Minimum Required):

University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure).

Minimum of 2 years of independent clinical monitoring experience.

Experience supporting study sites from initiation to close-out.

Thorough understanding of ICH GCP Guidelines and understanding of local regulatory requirements.

Thorough knowledge of monitoring procedures.

Fluent in local office language and in English, both written and verbal.

Must be based in either Kuala Lumpur or Selangor.

Preferred Qualifications Include:

Oncology therapeutic experience

Experience working under an FSP model or within an FSP team

Physical Demands/Work Environment:

Must be able to sit at a computer for long periods of time.

Must be able to use hands to finger, handle or touch objects, tools or controls, including a computer keyboard, for up to 8 hours per day.

Standard office and/or home working environment.

Clinical Research Unit and hospital environment (administrative only).

Risk of eye strain.

Will involve outside of normal office hours as required by the role.

Travel Requirement is 60% of the time (traveling to study sites).