Site Activation Partner - FSP (Contractor)

Overview

As a Clinical Research Associate (CRA) at Parexel, you act as an integral part to get treatments to patients sooner. Our CRAs' priority is the safety and well-being of the patients. As you travel to investigator sites and perform your monitoring duties, we encourage you to be inquisitive, take accountability, build relationships, and act with integrity.

Join a team with a wide variety of experiences and knowledge, and work on global projects within a broad scope of therapeutic areas. We’re looking for people who want to grow personally and professionally and support their colleagues globally and cross-functionally.

Success Profile

Do you have these soft skills and interpersonal traits to succeed at Parexel?

• Communicator
• Detail-oriented
• Flexible
• Organized
• Problem-solver
• Self-starter

About This Role

This role requires to commute to client's office 2-3 days a week

This role is a fixed term contract role; until April 2027

(Contract could be extended or convert to Regular based on business needs, but not guaranteed)

Key Accountabilities (may include but not limited to the following):

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 Pfizer 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

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

• 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)

• 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 (preferred):

• Minimum 2 years' relevant experience in clinical site management
• 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