Parexel FSP is hiring a Site Activation Partnerin Brazil!
TheSite Activation Partner(SAP)is responsible for leading or supporting operational activities from start- up to close-out, for assigned studies and investigator sites to ensure compliance with study timelines and in accordance with prevailing laws, Good Clinical Practices, and Client standards. Responsibility within a country and may span over more than 1 country depending on the geographical region and business needs.
Organizational Relationships:
Reports to Parexel-assigned Line Management with day-to-day direction from Client; refer to Organizational Chart for details regarding assigned role and associated reporting structure.
Primary Responsibilities:
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
Register investigator sites and Client stakeholders in Client registries and systems as required. Update and regularly maintain the registry with accuracy and have it inspection ready
Work directly and interact 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
Take the lead to resolve issues or concerns and timely escalation of Site issues where applicable
Prepare, validate and submit regulatory documents such as completed IIP, 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 (IRB) 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 preparation, handling and distribution of non-Clinical Trial Supplies and maintenance of tracking information as needed.
Collaborate with the Study Team on the development and readiness of sites electronic Investigator Site File (eISF) when utilized and act as primary point of contact for the sites and manage the Site Operations/CRO monitor access to eISF prior to Site Initiation Visit (SIV).
Assist with the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures.
Support & implement activities in SIP to align with Client strategy as it relates to the role.
Coordinate translation of documents that are within scope with the preferred translation vendors.
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 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
Internal & External Communication
Maintain ongoing contact and communication with the study team and respond promptly to study team and investigator site requests
Attend study Start-up meeting and provide functional updates on a country and site level
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
General
Completes training assigned by Client and/or EP, as necessary, including general training requirements, SOPs, system and process related training
Adhere to EP and Client SOPs and processes
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 (1) country
Additional Responsibilities
May be assigned as Site Activation Partner Point of Contact (PoC) on a study conducted in multi- country
May be assigned as a Subject Matter Expert (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
Ability to use and learn systems, and to use independently
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)
Education and Certification:
Skills 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
Knowledge of clinical trial methodologies, ICH/GCP, FDA and Global and local country regulations
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
Demonstrated 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. Demonstrate 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
Language Skills:
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