Site Activation Partner - FSP

SAP

Accountability

Clinical Trial Site Activation:

• Initiates and coordinates 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
  • Registers investigator sites and Client stakeholders in Client registries and systems as required. Updates and regularly maintains the registry with accuracy and inspection readiness
  • Works directly and interacts with investigator sites to confirm readiness for site start-up by reviewing study site profile ready in Shared Investigator Platform (SIP) or reviewing/completing critical information Sheet, inclusive of but not limited to Investigator Initiation Packages (IIP) essential documents components, site contracts contacts, clinical supply shipment information, payment information, IRB submission and status
  • Takes the lead to resolve issues or concerns and escalates site issues timely, where applicable
  • Prepares, validates and submits regulatory documents such as completed IIP, IRB approval forms, and FDA 1572/Attestation Form for internal regulatory approval within required timelines
  • Manages and coordinates with other supporting roles to ensure timely site activation and operational activities
  • Supports the compilation of the Central Investigator Review Board (IRB) package and submissions to approval of the study (where applicable) and other committees as per country requirements
  • Coordinates the timely communication, documentation and responses between Client and Central Ethics committee to bring clinical study to approval (country dependent)
  • Supports investigator’s sites with local IRB workflow from preparation, submission through approval
  • Assists with preparation, handling and distribution of non-Clinical Trial Supplies and maintenance of tracking information as needed
  • Collaborates with the Study Team on the development and readiness of sites electronic Investigator Site File (eISF) when utilized, acts as primary point of contact for the sites, and manages the Site Operations/CRO monitor access to eISF prior to Site Initiation Visit (SIV)
  • Assists with the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures
  • Supports and implements activities in SIP to align with Client strategy as it relates to the role
  • Coordinates translation of documents that are within scope with the preferred translation vendors
  • May serve as SAP Point of Contact (PoC) on a study conducted in multiple countries
  • May serve as a Subject Matter Expert (SME) on a project, initiative, system and/or process, and represent the SAP function as applicable
  • Supports the mentoring of new hires on processes and systems

Clinical Trials Conduct:

• Post site activation, initiates and coordinates activities and essential documents management with the investigator’s sites towards the compilation of 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
• Ensures maintenance of IRB/Ethics and other committees’ activities as applicable
• Files documents timely to the Trial Master File and assists with periodic quality review of study files for accuracy and completeness
• Accurately updates and maintains clinical trial systems that track site compliance and performance within project timelines
• Supports investigator sites and study teams to prepare for and provide responses to site audits/inspections

Internal and External Communication:

• Maintains ongoing contact and communication with the study team and responds promptly to study team and investigator site requests
• Attends Study Start-up meeting and provides functional updates on a country and site level
• Establishes tools for efficient updates to study team as needed regarding site status, issues, delays, approvals
• Disseminates Central or Local Ethics Approval to study team and Investigator Sites where applicable
• Communicates local sites’ approvals to study team members and stakeholders

Clinical Trial Site Support :

• As needed, conducts awareness sessions with site personnel on Client requirements and ensures ongoing compliance with study documentation in accordance with prevailing laws, Good Clinical Practices, and Client standards
• Identifies and resolves investigator site issues within required timeframes; aligns with study team and local country colleagues on corrective and preventative actions to close open issues and to prevent recurrence / persistence of issues

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:

• Must be fluent in local language and in English; multilingual capability is preferred
• For 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
• Proficient in computer operations with good technical skills and ability to learn and use multiple systems:
• Microsoft Suite
• Clinical Trial Management Systems (CTMS)
• Electronic Trial Master File
• Electronic Investigator Site File (e.g., Florence)
• Document exchange portals
• Shared Investigator Platform
• Ethics, National Networks and Governing Bodies Portals and platforms (as needed)
• Ability to work independently and as a team member
• Ability to organize tasks, time and priorities, and multi-task

Knowledge and Experience:

• Minimum 2 years’ relevant experience in clinical site management
• Experience working in the pharmaceutical industry/or CRO in study site activation is preferred
• A good understanding of the Site Activation requirements and processes within the country/region and to able to learn and potentially implement in more than one country
• Knowledge of clinical trial methodologies, ICH/GCP, FDA and Global and local country regulations
• Demonstrated knowledge of clinical research and development processes, key operational elements of a clinical trial, and ability to gain command of process details
• Understanding of the quality expectations and emphasis on right first time. Demonstrate compliance with all applicable company, regulatory and country requirements. Attention to detail evident in a disciplined approach
• Understanding of basic medical terminology and GCP requirements

Education:

• School diploma/certificate with equivalent combination of education, training, and experience
• Bachelor’s of Science, Bachelor’s of Arts or Bachelor’s in Life Sciences degree is preferred