Clinical Trial Coordinator- Finance- 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 looking for a Clinical Trial Coordinator with experience with budget negotiation. This position is a hybrid position with 1-day minimum onsite requirement in Kirkland, Quebec. Job Title: Clinical Trial Coordinator (CTC) Position Purpose: The Clinical Trial Coordinator (CTC) is responsible for the following: • Supports the Clinical Research Manager (CRM) and other team members through the life cycle of the study from study start up to study closure. 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: • Trial and site administration: o Tracking (e.g., essential documents) and reporting (e.g., Safety Reports). o Ensure collation and distribution of study tools and documents. o Update clinical trial databases (CTMS) and trackers. o Clinical supply & non‐clinical supply management, in collaboration with other country roles. o Manage Labeling requirements and coordinate/sign translation change request. • Document management: o Prepare documents and correspondence. o Collate, distribute/ship, and archive clinical documents. o Assist with electronic Trial Master File (eTMF) reconciliation. o Updating manuals/documents (e.g., patient diaries, instructions). o Document proper destruction of clinical supplies. o Prepare Investigator trial file binders. o Execute eTMF Quality Control Plan. o Obtain translations of documents. • Regulatory & Site Start Up responsibilities: o Provide to and collect from investigators forms/lists for site evaluation/validation, site start‐up and submissions in a timely manner. o Obtain, track and update study insurance certificates. o Support preparation of submission package for Institutional Review Board (IRB) / Ethics Review Committee (ERC) and support regulatory agencies submissions. o Publish study results for Global Clinical Trial Operations (GCTO) and Regulatory Affairs (RA) where required per local legislation. • Budgeting, Agreement and Payments: Collaborate with finance/budgeting representatives for: o Development of country and site budgets (including Split site budget). o Tracking and reporting of negotiations. o Maintenance of tracking tools. o Working knowledge of contract development, negotiation, approval, and maintenance (e.g., Clinical Trial Research Agreements (CTRAs)). o Updating and maintenance of contract templates (in cooperation with Legal Department) o Payment calculation and execution (investigators, vendors, grants o Ensuring compliance with financial procedures. o Monitoring and tracking adherence and disclosures. o Budget closeout. o Obtain and process Foreign Corrupt Practices Act (FCPA) documentation in a timely manner. • Meeting Planning: o Organize meetings (create & track study memos/letters/protocols). o Support local investigator meetings (invitations, prepare materials, select venue, support where applicable). • Completes training assigned by Client and/or EP, as necessary, including general training requirements, SOPs, and system and process related training. • Adheres to EP and Client SOPs and processes. Education and Certification: • B.A./B.S. (Life Sciences preferred) or equivalent healthcare experience. Skills and Experience: • Minimum 1-2 years in Clinical Research or relevant healthcare experience. Note - Specific experience requirements may vary depending on the Country • 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 Committee on Harmonization (ICH) ‐ Good Clinical Practice (GCP) 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 CTC team knowledge by acting as buddy /mentor and sharing best practices as appropriate/required. Language Skills: • Fluent in Local Languages and business proficient in English (verbal and written) and excellent communication skills. #LI-KW1