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 (may include but not limited to the following):
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 Pfizer 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
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
o Microsoft Suite o Clinical Trial Management Systems (CTMS)
o Electronic Trial Master File
o Electronic Investigator Site File (e.g. Florence) o 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 (preferred):
• Minimum 2 years' relevant experience in clinical site management
• 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
Top Skills
What We Do
Parexel is among the world’s largest clinical research organizations (CROs), providing the full range of Phase I to IV clinical development services to help life-saving treatments reach patients faster. Leveraging the breadth of our clinical, regulatory and therapeutic expertise, our team of more than 21,000 global professionals collaborates with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind, increasing access and participation to make clinical research a care option for anyone, anywhere. Our depth of industry knowledge and strong track record gained over the past 40 years is moving the industry forward and advancing clinical research in healthcare’s most complex areas, while our innovation ecosystem offers the best solutions to make every phase of the clinical trial process more efficient. With the people, insight and focus on operational excellence, we work With HeartTM every day to treat patients with dignity and continuously learn from their experiences, so every trial makes a difference. For more information, visit parexel.com.
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