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
- 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