Site Activation Partner I - Fsp

**When our values align, there's no limit to what we can achieve.**   At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. **Key Accountabilities:**  **Clinical Trial Site Activation:**  * Initiate and coordinate activities and essential documents management during start up towards the compilation of a high quality Investigator Initiation Package (IIP) leading to approval for site initiation   *  Provide support to resolve issues or concerns and timely escalation of site issues where applicable   *  Prepare, validate and submit regulatory documents such as completed IIP, Institutional Review Board (IRB) approval forms, FDA 1572/Attestation Form, for internal regulatory approval within required timelines   * Manage and coordinate with other supporting roles to ensure timely site activation and operational activities   *  Support the compilation of the Central Investigator Review Board package and submissions to approval of the study (where applicable) and other committees as per country requirements   *  Coordinate the timely communication, documentation and responses between client and central ethics committee to bring clinical study to approval (country dependent)   * Support investigators sites with local IRB workflow from preparation, submission through approval   * Assist with the preparation, handling, and distribution of clinical documentation and reports according to the scope of work and standard operating procedures   *  Support and implement activities in Shared Investigator Platform (SIP) to align with the client’s strategy as it relates to the role  **Clinical Trials Conduct:**  * Post site activation, initiate and coordinate activities and essential documents management with the investigator’s sites towards the compilation of a high quality documents and updates through the life cycle of a study such as the documents management for protocol amendments, FDA 1572/Attestation revisions, ethics committee annual approvals and other activities required during study conduct   *  Ensure maintenance of IRB/Ethics and other committees’ activities as applicable   * Responsible for timely filing of documents to Trial Master File (TMF) and assisting with periodic quality review of study files for accuracy and completeness   * Accurately update and maintain clinical trial systems that track site compliance and performance within project timelines   * Supports investigator sites, and study teams in preparation for and providing responses to site audits / inspections  **Communication:**  * Maintain ongoing contact and communication with the study team and respond promptly to study team and investigator site requests   *  Provide functional updates on a country and site level as required   * Establish tools for efficient updates to study team as needed regarding site status, issues, delays, approvals   * Disseminate central or local ethics approval to study team and Investigator sites where applicable   *  Communicate local sites approvals to study team members and stakeholders  **Clinical Trial Site Support:**  * As needed, perform, awareness session with site personnel on client requirements and to ensure ongoing compliance with study documentation in accordance with prevailing laws, Good Clinical Practices, and client standards   *  Identify and resolve investigator site issues within required timeframes; align with study team and local country colleagues on corrective and preventative actions to close open issues and to prevent recurrence / persistence of issues  **Subject Matter Expert (SME):**  * A good understanding of the site activation requirements and processes within the country/region and be able to learn and potentially implement in more than one country   *  May be assigned as Site Activation Partner Point of Contact (PoC) on a study conducted in multiple countries   * May be assigned as an SME on a system and/or process, and represent the SAP function as applicable   *  May represent the SAP role on global initiatives   *  Able to act as an SME on projects and initiatives, as requested   *  Support the mentoring of new hires on processes/ systems  **Compliance with Parexel standards:**  * Complies with required training curriculum   *  Completes timesheets accurately as required   * Submits expense reports as required   * Updates CV as required   * Maintains a working knowledge of and complies with Parexel processes, ICH-GCPs and other applicable requirements  **Skills:**  * Knowledge of clinical research and development processes, key operational elements of a clinical trial, and ability to gain command of process details  *  Understand the quality expectations and emphasis on right first time   *  Compliance with all applicable company, regulatory and country requirements   * Attention to detail evident in a disciplined approach   *  Ability to work independently and also as a team member   * Ability to organize tasks, time and priorities, ability to multi-task   * Understand basic medical terminology, GCP requirements and proficient in computer operations   *  Ability to use and learn systems, and to use independently   * Microsoft Suite o Clinical Trial Management Systems (CTMS)   * Electronic Trial Master File o Electronic Investigator Site File (e.g. Florence)  * Document exchange portals o Shared Investigator Platform o Ethics, National Networks and Governing Bodies Portals and platforms (as needed)  *   Flexible and adapt to off working hours in a global environment (when applicable)   *  Able to travel as needed, including some international travel possible  **Knowledge and Experience:**  * Experience working 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   *  Must be fluent in local language and in English. Multilanguage capability is preferred   *  Individuals based in Canada: Bilingualism (French, English) is preferred   *  Effective verbal and written communication skills in relating to colleagues and associates both inside and outside of the organization   *  Good technical skills and ability to learn and use multiple systems  **Education:**  * School diploma or certificate with equivalent combination of education, training and experience or Bachelor of Science or Bachelor of Arts or equivalent   *  Education in life sciences discipline is preferred   * Minimum 2 years relevant experience in clinical site management