Clinical Trial Coordinator (Regulatory) - FSP

Job description

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 seeking Clinical Trial Coordinators to join our team in Canada ! Candidates should 1-2 years of experience in clinical research, bilingual in english and french and be open to go to sponsor's office in Montreal, Kirkland 2x/week. Job Summary The Clinical Trial Coordinator supports the Clinical Research Manager and other team members through the life cycle of the study from study start up to study closure. Key Accountabilities: Trial and site administration: Tracking (e.g., essential documents) and reporting (e.g., Safety Reports) Ensure collation and distribution of study tools and documents Update clinical trial databases and trackers Clinical supply & non-clinical supply management, in collaboration with other country roles Manage Labeling requirements and coordinate/sign translation change request Document management: Prepare documents and correspondence Collate, distribute/ship, and archive clinical documents Assist with electronic Trial Master File reconciliation Updating manuals/documents (e.g., patient diaries, instructions Document proper destruction of clinical supplies Prepare Investigator trial file binders Execute electronic Trial Master File Quality Control Plan Obtain translations of documents Regulatory & Site Start Up responsibilities: Provide to and collect from investigators forms/lists for site evaluation/validation, site start-up and submissions in a timely manner Obtain, track and update study insurance certificates Support preparation of submission package for Institutional Review Board / Ethics Review Committee and support regulatory agencies submissions Publish study results for Global Clinical Trial Operations and Regulatory Affairs where required per local legislation Budgeting, Agreement and Payments: Development of country and site budgets (including Split site budget) Tracking and reporting of negotiations Maintenance of tracking tools Working knowledge of contract development, negotiation, approval, and maintenance (e.g., Clinical Trial Research Agreements) Updating and maintenance of contract templates (in cooperation with Legal Department) Payment calculation and execution (investigators, vendors, grants) Ensuring compliance with financial procedures Monitoring and tracking adherence and disclosures Budget closeout Obtain and process Foreign Corrupt Practices Act documentation in a timely manner Meeting Planning: Organize meetings (create & track study memos/letters/protocols) Support local investigator meetings (invitations, prepare materials, select venue, support where applicable) Compliance with Parexel Standards: • Complies with required training curriculum Completes timesheets accurately and timely 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: Fluent in Local Languages and business proficient in English (verbal and written) and excellent communication skills Good understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines Hands on knowledge of Good Documentation Practices Good IT skills (Use of MS office, use of some clinical IT applications on computer) and ability to adapt to new IT applications. Strong MS Excel skills required International Council for Harmonization ‐ Good Clinical Practice knowledge appropriate to role Effective time management, organizational and interpersonal skills, conflict management Effective communication with external customers (e.g., sites and investigators) High sense of accountability / urgency. Ability to set priorities and handle multiple tasks simultaneously in a changing environment Works effectively in a matrix multicultural environment. Ability to establish and maintain culturally sensitive working relationships. Demonstrates commitment to Customer focus Able to work independently Proactive attitude to solving problems / proposing solutions Positive mindset, growth mindset, capable of working independently with assigned tasks Contributes to Clinical Trial Coordinator team knowledge by acting as buddy /mentor and sharing best practices as appropriate/required Knowledge and Experience: Minimum 1-2 years in Clinical Research or relevant healthcare experience Note - Specific experience requirements may vary depending on the Country. Education: Bachelor’s degree (Life Sciences preferred) or equivalent healthcare experience #LI-Hybrid