Site Activation Partner - FSP (Study Start-Up Associate)

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.

External Job Description

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 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 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

- Support and implement activities in Shared Investigator Platform (SIP) to align with the client’s strategy as it relates to the role

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

Compliance with Parexel standards:

- Complies with required training curriculum

- Completes timesheets accurately as required

- Submits expense reports as required

- Updates CV as required

- Maintains a working knowledge of and complies with Parexel processes, ICH-GCPs and other applicable requirements

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

- Microsoft Suite o Clinical Trial Management Systems (CTMS)

- Electronic Trial Master File o Electronic Investigator Site File (e.g. Florence)

- 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

- Individuals based in Canada: Bilingualism (French, English) 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