Clinical Research Associate II
hace 4 semanas
Job Summary
As a Clinical Research Associate II at Pharmiweb, you will be responsible for site management and monitoring of clinical studies. You will ensure the protection of subjects, safeguard data integrity, and confirm site regulatory documents are complete and current.
Key Responsibilities
- Conduct site monitoring responsibilities for clinical trials, including pre-study, site initiation, process monitoring, routine monitoring, and close-out visits.
- Prepare and implement project plans related to clinical monitoring responsibilities.
- Ensure the protection of subjects by verifying informed consent procedures and protocol requirements.
- Safeguard data integrity by careful source document review and verification.
- Confirm site regulatory documents and applicable eTMF/Sponsor Documents are complete and current.
- Guarantee that the study Investigational Product inventory and accountability is accurate.
- Ensure adherence to global quality control and CRA performance metrics.
- Ensure audit readiness at site level.
- Act in the project role of a Lead CRA as assigned.
- Ensure study staff have received the proper materials and instructions.
- Ensure the integrity of the source data reported.
- Monitor data for missing or implausible data.
- Ensure study data completeness, accuracy, consistency, and compliance.
- Perform required monitoring tasks efficiently, including managing travel expenses.
- Prepare and submit accurate and timely trip reports.
- Independently perform eCRF review and source data verification.
- Assist with the administration of clinical research projects.
- Update and maintain trial management tools/e-Clinical systems.
- Track IP shipments and supplies.
- Track and follow-up on serious adverse events.
- Work closely with the study team to ensure study deliverables are met.
- Prepare and implement study-specific monitoring plans.
- Attend investigators' meetings and project team meetings.
- Present training content for site initiation.
- Assist with training of new employees.
- Perform other duties as assigned by management.
Qualifications
- University or college degree, or certification in a related allied health profession from an appropriately accredited institution.
- Thorough understanding of ICH GCP Guidelines and 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.
- A minimum of 2 years of Clinical Monitoring experience.
About Pharmiweb
Pharmiweb is a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience. We provide pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas.
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