Site Activation Partner – Study Start-Up Associate

🔥 2 minutes ago

🇦🇺 Australia – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

🪙 Affiliate Manager

🚫👨‍🎓 No degree required

👻 Ghost score 10%

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Parexel

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1983

💼 Consulting

🏥 Healthcare

📦 Logistics

💰 Venture Round on 1990-01

Consulting • Healthcare • Logistics

Parexel is one of the world's largest clinical research organizations (CROs), providing comprehensive services for the clinical development process from Phase I to IV. The company specializes in portfolio management, clinical trial management, regulatory strategy, market access, and lifecycle management for biopharmaceuticals. Parexel aims to speed life-changing medicines to market by leveraging its clinical, regulatory, and therapeutic expertise. With a global team of over 21,000 professionals, Parexel works to integrate patient insights and innovative trial designs to develop treatments across therapeutic areas such as oncology, neuroscience, rare diseases, and more. It focuses on delivering patient-centric and efficient clinical trials.

📋 Description

• Initiate and coordinate clinical trial site activation activities and essential document management • Compile high-quality Investigator Initiation Packages leading to site initiation approval • Resolve or escalate site issues in a timely manner • Prepare, validate, and submit regulatory documents, including IIP, IRB approval forms, and FDA 1572/Attestation Forms • Coordinate supporting roles and activities to ensure timely site activation • Support central and local ethics committee packages, submissions, communications, and approvals • Support investigators with local IRB workflows from preparation through approval • Prepare, handle, and distribute clinical documentation and reports according to scope of work and SOPs • Support and implement activities in the Shared Investigator Platform • Manage site documentation and updates throughout study conduct, including protocol amendments, FDA 1572/Attestation revisions, and ethics committee annual approvals • Maintain IRB/Ethics and other committee activities as applicable • File documents to the Trial Master File and assist with periodic quality reviews • Update and maintain clinical trial systems tracking site compliance and performance • Support investigator sites and study teams during audits and inspections • Maintain communication with study teams and investigator sites and respond to requests • Provide country- and site-level functional updates and establish tools for efficient status reporting • Disseminate central and local ethics approvals to study teams and investigator sites • Conduct awareness sessions on client requirements and ongoing documentation compliance as needed • Identify and resolve site issues and coordinate corrective and preventative actions • Serve as a Site Activation Partner point of contact, subject matter expert, mentor, or representative on initiatives as assigned • Complete required training, timesheets, expense reports, and CV updates • Maintain compliance with Parexel processes, ICH-GCP, and applicable requirements

🎯 Requirements

• Knowledge of clinical research and development processes and key operational elements of a clinical trial • Understanding of quality expectations and emphasis on right first time • Compliance with applicable company, regulatory, and country requirements • Disciplined attention to detail • Ability to work independently and as a team member • Ability to organize tasks, time, and priorities and multitask • Basic medical terminology and GCP requirements • Proficient in computer operations and able to learn and use systems independently • Microsoft Suite • Clinical Trial Management Systems (CTMS) • Electronic Trial Master File and Electronic Investigator Site File systems, e.g. Florence • Document exchange portals • Shared Investigator Platform • Ethics, national networks, and governing bodies portals and platforms as needed • Flexibility for off-hours work in a global environment when applicable • Able to travel as needed, including possible international travel • Experience in the pharmaceutical industry or CRO in study site activation preferred • Knowledge of clinical trial methodologies, ICH/GCP, FDA, and global and local country regulations • Fluent in the local language and English • Multilanguage capability preferred • Effective verbal and written communication skills • Good technical skills and ability to learn and use multiple systems • School diploma or certificate with equivalent combination of education, training, and experience, or Bachelor of Science/Bachelor of Arts or equivalent • Minimum 2 years of relevant experience in clinical site management • Education in a life sciences discipline preferred

🏖️ Benefits

• No benefits, perks, or compensation extras are specified in the posting