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