Site Activation Partner I - FSP

Parexel; Brasil; Presencial; BRL 120 000 - 180 000; Tempo integral

Resumo da oferta

Parexel is seeking a Site Activation Partner to support start-up activities across multiple countries in Latin America. The role involves coordinating essential documents, site activations, and regulatory submissions to ensure study timelines are met and compliant with global standards.

Candidates should have at least 3 years in start-up with US/Canada and be adept at interacting with investigator sites, IRBs, and study teams to drive timely approvals and activation.

Qualificações

• 3+ years of start-up experience with US/Canada.
• Experience coordinating regulatory submissions and site activation.
• Familiarity with Investigator Initiation Packages (IIP) and regulatory timelines.

Responsabilidades

• Lead or support site activation activities from start-up to close-out.
• Coordinate regulatory documents (IIP, IRB approvals, FDA forms) within required timelines.
• Maintain and update site registries and essential documents for inspection readiness.

Conhecimentos

Site Activation

IRB/Submissions

Regulatory documents

Ferramentas

SIP platform

eISF

Descrição da oferta de emprego

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.

Parexel FSP is hiring a Site Activation Partner in Mexico, Argentina or Brazil ! Candidates must have at least 3 years of experience in start-up working with US/Canada.

The Site 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

• Attend study Start-up meeting and provide functional updates on a coun