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 timeline
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
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
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:
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
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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