Senior Clinical Research Associate

4 weeks ago

Sydney, New South Wales, Australia Pharmiweb Full time
Job Summary

Pharmiweb is seeking a highly skilled Senior Clinical Research Associate to join our team. As a Senior Clinical Research Associate, you will be responsible for performing site qualification, site initiation, interim monitoring, site management and close-out visits, ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance.

Key Responsibilities

Performs site qualification, site initiation, interim monitoring, site management and close-out visits, ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance.
Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the project team and develops action plans.
Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes.
Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient as required/appropriate.
Demonstrates diligence in protecting the confidentiality of each subject/patient.
Assesses factors that might affect subject/patient's safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues.

Requirements

Bachelor's degree or RN in a related field or equivalent combination of education, training and experience.
Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements.
Must demonstrate good computer skills and be able to embrace new technologies.
Excellent communication, presentation and interpersonal skills.
Basic level of critical thinking skills expected.
Ability to manage required travel of up to 75% on a regular basis.

About Pharmiweb

Pharmiweb is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Pharmiweb easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE

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