Site Activation Partner I - FSP (Fixed-Term 7 months)

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 2 years of experience in start-up working with US/Canada. This is a 7-month temporary assignment with the potential to transition into a full-time role.

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

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:

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

Skills and Experience:

Minimum 3 years’ relevant experience in clinical site management, working with US/Canada.

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 o