Senior Clinical Research Associate

🔥 0 minutes ago

🇦🇺 Australia – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

👻 Ghost score 22%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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Precision Medicine Group

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 2012

💼 Consulting

🏥 Healthcare

📦 Logistics

💰 $35.2M Venture Round on 2021-03

Consulting • Healthcare • Logistics

Precision Medicine Group is a global team of experts that specializes in precision medicine, which combines advanced lab sciences, translational informatics, regulatory affairs, payer insights, and marketing communications. The company focuses on overcoming product development and commercialization challenges for pharmaceutical and life sciences clients. Their services include biomarker-driven research and development, as well as commercialization support for life science organizations from launch to product maturity. Precision Medicine Group operates through two main arms: Precision for Medicine and Precision AQ, specializing in clinical and commercial solutions respectively.

📋 Description

• Provide overall support to study sites and clinical project teams engaged in clinical research studies • Adhere to applicable protocols, SOPs, ICH-GCP, GPP, and country/region-specific regulations • Act as point of contact for study sites • Execute core responsibilities independently across several studies, including complex activities • Oversee study site management to protect patient safety and ensure high-quality data • Provide guidance on audit readiness and support audit preparation and follow-up actions • Update and maintain trial management tools, systems, and status reports • Manage site start-up procedures when required, including feasibility, investigator recruitment, EC/IRB submissions, regulatory documents, informed consents, notifications, translations, and meetings • Assist with study budget negotiations and investigator contracts when required • Verify informed consent processes and assess patient safety and data integrity risks • Conduct pre-study, qualification, initiation, routine monitoring, and close-out site visits, both on-site and remotely • Prepare accurate and timely monitoring reports • Document site activities and maintain tracking systems and action items • Support patient recruitment, retention, and awareness strategies • Review Investigator Site Files and reconcile them with Trial Master Files • Communicate protocol issues, deviations, and required actions to site and project teams • Maintain relationships with investigators and study staff • Manage investigational product inventory, reconciliation, storage, dispensing, labeling, import, and return processes • Perform EDC CRF and patient profile reviews, resolve queries, and assist with data discrepancies • Identify and process Serious Adverse Events • Identify and escalate site risks and own timely resolution • Attend investigator, sponsor, clinical monitoring, project, and training meetings • Travel as necessary according to project needs • Perform other duties assigned by management

🎯 Requirements

• Bachelor's degree / international equivalent or equivalent combination of education and experience ideally in a business, scientific or healthcare discipline • Minimum of 3 years of on-site monitoring experience • High proficiency in Microsoft Office (Outlook, Word, Excel, and PowerPoint) • Customer service demeanour; flexibility and teamwork • Ability to focus on detail for extended periods and high attention to accuracy • Fluency in English communication, verbally and in writing • Working knowledge of the drug development process • Travelling required (60-70%) • Good knowledge and utilization of ICH-GCP, Precision SOPs, and regulatory guidance • Solid interpersonal, written, verbal communication, and presentation skills • Ability to work and plan independently as well as in a team environment • Ability to deliver on commitments • Commitment to performing professionally consistent with Precision Principles • Two years of oncology and Phase I experience preferred • Solid experience in clinical research or related experience preferred • Excellent organizational skills preferred • Ability to work efficiently in a remote work environment preferred

🏖️ Benefits

• Employees are appreciated for their contributions • Employee input and ideas are valued and nurtured • Equal Opportunity Employer • Reasonable accommodations available for applicants with disabilities