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
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