Job Description
The role of a Site Activation Partner is pivotal in the success of clinical trials. This position requires a highly organized and detail-oriented individual who can manage multiple tasks simultaneously.
Clinical Trial Site Activation
* An essential responsibility of this role is to initiate and coordinate activities leading to site activation, ensuring compliance with study timelines and regulatory requirements.
* This involves registering investigator sites and maintaining accurate records, as well as communicating effectively with sites to confirm readiness for start-up.
* The Site Activation Partner must be proactive in resolving issues and escalating concerns to ensure timely site activation and operational activities.
Clinical Trials Conduct
* Post-site activation, the Site Activation Partner will coordinate activities and manage essential documents to ensure compliance with study protocols and regulations.
* This includes maintaining IRB/Ethics and other committee activities, as well as ensuring timely filing of documents and periodic quality review of study files.
Clinical Trial Site Support
* The Site Activation Partner will provide support to investigator sites, including awareness sessions on client requirements and ongoing compliance with study documentation.
* This role also involves identifying and resolving site issues within required timeframes, aligning with the study team and local country colleagues on corrective and preventative actions.
Additional Responsibilities
* The Site Activation Partner may be assigned as a Point of Contact (PoC) on multi-country studies or serve as a Subject Matter Expert (SME) on specific systems or processes.
* They will also collaborate with the Study Team on the development and readiness of sites' electronic Investigator Site File (eISF) and act as the primary point of contact for sites and manage monitor access to eISF prior to Site Initiation Visit (SIV).
Required Skills and Qualifications
* A Bachelor's degree is required, with a minimum 2 years' relevant experience in clinical site management, preferably in study site activation.
* The ideal candidate should possess fluent/advanced spoken and written English language skills and have knowledge of clinical trial methodologies, ICH/GCP, FDA, and global/local country regulations.
* Effective verbal and written communication skills are essential, as is good technical skill and the ability to learn and use multiple systems.
Benefits
Parexel offers a dynamic work environment where employees can develop their long-term careers and tackle further responsibilities or develop their skill set within other related departments.