Clinical Research Associate II
hace 1 semana
As a Clinical Research Associate II at Pharmiweb, you will play a critical role in the success of our pharmaceutical trials. We are seeking a highly skilled and experienced professional to join our team as a Site Management Expert.
Key Responsibilities
- Conduct site monitoring responsibilities for clinical trials according to our Standard Operating Procedures (SOPs), ICH guidelines, and GCP.
- Prepare and implement project plans related to Clinical Monitoring responsibilities.
- Ensure the protection of subjects by verifying that informed consent procedures and protocol requirements are adhered to alongside applicable regulatory requirements.
- Safeguard data integrity by careful source document review, source document verification, query generation, and resolution against established data review guidelines on our or client data management systems.
- Confirm Site Regulatory documents and applicable eTMF/Sponsor Documents are complete and current throughout the duration of the trial.
- Guarantee that the study Investigational Product inventory and accountability is accurate and that study materials are stored securely and per protocol requirements.
- Ensure adherence to global quality control and CRA performance metrics.
- Ensure audit readiness at the site level.
- Act 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 Pharmiweb 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 our travel policy.
Requirements
- Travel, including air travel, may be required and is an essential function of the job.
- Prepare and submit accurate and timely trip reports.
About Us
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. With over 19,000 staff conducting operations in more than 90 countries, we are transforming drug and device development for partners and patients across the globe.
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