Site Activation Partner I - FSP

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