Clinical Research Associate II

4 weeks ago

Melbourne, Victoria, Australia Pharmiweb Full time
Job Summary

We are seeking a highly skilled Clinical Research Associate II to join our team at Pharmiweb. As a Clinical Research Associate II, you will be responsible for performing site qualification, site initiation, interim monitoring, site management activities, and close-out visits to ensure regulatory, ICH-GCP, and protocol compliance.

Key Responsibilities

• Perform site qualification, site initiation, interim monitoring, site management activities, and close-out visits to ensure regulatory, ICH-GCP, and protocol compliance.
• Verify the process of obtaining informed consent has been adequately performed and documented for each subject/patient.
• Assess factors that might affect subject/patient's safety and clinical data integrity at an investigator/physician site.
• Conduct Source Document Review of appropriate site source documents and medical records.
• Verify required clinical data entered in the case report form (CRF) is accurate and complete.

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.
• Excellent communication, presentation, and interpersonal skills.
• Ability to manage required travel of up to 75% on a regular basis.

About Us

Pharmiweb is a leading 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 make us easier to work with and for.

Why Work with Us

We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. We are continuously building the company we all want to work for and our customers want to work with. When we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong.

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