Site Management Professional
hace 2 semanas
CDS Fortrea Inc. is seeking a highly skilled and experienced Clinical Research Associate to join our team. As a Clinical Research Associate, you will be responsible for all aspects of study site monitoring, including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits, and liaison with vendors.
Key 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 Labcorp 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 Labcorp 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.
- University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure).
- Thorough knowledge of ICH Guidelines and understanding of local regulatory requirements.
- Strong experience with Clinical Monitoring experience.
- Ability to monitor study sites independently according to protocol monitoring guidelines, SOP, and local regulatory Guidelines.
- Have a full 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.
- Ability to work with minimal supervision.
- Good communication and interpersonal skills.
- Good analytical and negotiation skills.
- Computer competency.
- Fluent in local office language and in English, both written and verbal.
- Works efficiently and effectively in a matrix environment.
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Cost Management Professional
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Senior Cost Management Professional
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Clinical Research Associate
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Ciudad de México, Ciudad de México MMATISS A tiempo completoKey Responsibilities:Manages clinical investigational sites, ensuring compliance with regulatory requirements and protocol guidelines.Key Accountabilities:Trains and directs investigators and site staff on clinical trial protocols and procedures.Reviews and verifies clinical documentation to ensure accuracy and completeness.Maintains drug accountability and...
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Senior Cost Management Professional
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Site Superintendent
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Site Activation Specialist
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Global Benefits Management Professional
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Senior Facilities Management Director
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Senior Cash Management Specialist
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Site Intelligence Specialist
hace 1 semana
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Risk Management and Actuarial Professional
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Lease Administration Professional
hace 2 días
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Clinical Data Management Team Lead
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Global Benefits Management Professional
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Global Benefits Management Professional
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Risk Management Professional
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