Site Activation Partner – Study Start-Up Associate

This is a fully remote position, open to applicants in Australia.

📋 Description

• Initiate and oversee clinical trial site activation tasks along with essential document management.

• Assemble high-quality Investigator Initiation Packages that lead to site initiation approval.

• Address or escalate site-related issues promptly.

• 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.

• Assist with central and local ethics committee packages, submissions, communications, and approvals.

• Aid investigators with local IRB workflows from preparation through to approval.

• Prepare, manage, and distribute clinical documentation and reports in accordance with the scope of work and SOPs.

• Support and implement activities within the Shared Investigator Platform.

• Manage site documentation and updates throughout the study, including protocol amendments, FDA 1572/Attestation revisions, and ethics committee annual approvals.

• Maintain activities related to IRB/Ethics and other committees as necessary.

• Organize documents for the Trial Master File and assist with periodic quality reviews.

• Update and maintain clinical trial systems for tracking site compliance and performance.

• Support investigator sites and study teams during audits and inspections.

• Maintain communication with study teams and investigator sites, responding to requests.

• Provide functional updates at the country and site level and establish tools for efficient status reporting.

• Distribute central and local ethics approvals to study teams and investigator sites.

• Conduct informational sessions on client requirements and ongoing documentation compliance as needed.

• Identify and resolve site issues while coordinating corrective and preventative actions.

• Act as a Site Activation Partner point of contact, subject matter expert, mentor, or representative on assigned initiatives.

• Complete mandatory training, timesheets, expense reports, and CV updates.

• Ensure compliance with Parexel processes, ICH-GCP, and applicable regulations.

⛳️ Requirements

• Familiarity with clinical research and development processes as well as key operational aspects of a clinical trial.

• Comprehension of quality expectations with a focus on 'right first time' principles.

• Adherence to applicable company, regulatory, and country-specific requirements.

• Strong attention to detail.

• Capability to work independently and collaboratively within a team.

• Proficiency in organizing tasks, managing time and priorities, and multitasking.

• Basic understanding of medical terminology and GCP requirements.

• Competency in computer operations and ability to learn and utilize systems independently.

• Proficient in Microsoft Suite.

• Experience with Clinical Trial Management Systems (CTMS).

• Familiarity with Electronic Trial Master File and Electronic Investigator Site File systems, e.g., Florence.

• Knowledge of document exchange portals.

• Experience with the Shared Investigator Platform.

• Understanding of ethics, national networks, and governing body portals and platforms as required.

• Willingness to work off-hours in a global context when necessary.

• Ability to travel as required, including potential international travel.

• Previous experience in the pharmaceutical industry or CRO related to study site activation is preferred.

• Knowledge of clinical trial methodologies, ICH/GCP, FDA, and relevant global and local regulations.

• Proficiency in the local language and English.

• Multilingual capabilities are preferred.

• Strong verbal and written communication skills.

• Good technical abilities and aptitude for learning and using various systems.

• High school diploma or certificate with a relevant combination of education, training, and experience, or a Bachelor of Science/Bachelor of Arts or equivalent.

• At least 2 years of relevant experience in clinical site management.

• Education in a life sciences field is preferred.

🏝️ Benefits

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