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Clinical Research Associate II
hace 2 semanas
Summary Of Responsibilities
- Site management for clinical studies is conducted in accordance with Fortrea's Standard Operating Procedures, ICH GCP Guidelines, applicable project plans, and sponsor requirements. This includes verifying that study training records are complete and accurate.
- Site monitoring responsibilities cover all phases of a clinical trial—Pre-study, Site Initiation, Process Monitoring, Routine Monitoring, and Close-out Visits—ensuring compliance with regulatory and protocol standards.
- Project plans related to clinical monitoring are prepared and implemented to align with study timelines and deliverables.
- Subject protection is ensured through eligibility reviews and verification that informed consent procedures and protocol requirements are followed in accordance with regulatory expectations.
- Data integrity is safeguarded through thorough source document review, source data verification, query generation and resolution, all performed using Fortrea or sponsor data management systems.
- Site regulatory documentation and eTMF/Sponsor files are maintained to be complete and current throughout the trial duration, ensuring audit readiness.
- Investigational Product inventory and accountability are confirmed to be accurate, with secure storage and handling per protocol. Additional responsibilities include supporting CRA performance metrics, acting as Lead CRA when assigned, and collaborating with study teams to meet project goals.
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.
- 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
- A minimum of 2 years of Clinical Monitoring experience.
- Ability to monitor study sites independently according to monitoring plan, project requirements, SOPs, and ICH GCP guidelines.
- Therapeutic area' expertise required: expertise in oncology and hematology, and expertise in CAR-T is a plus.
Preferred Qualifications Include
- Good understanding of the principles of ICH GCP, ISO if applicable) and local regulatory requirements.
- Good analytical and negotiation skills.
- Experience using e-clinical systems [e.g., clinical trial management system (CTMS)].
Physical Demands/Work Environment
- 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.
