[Remote] Clinical Trial Coordinator - FSP

Note: The job is a remote job and is open to candidates in USA. Parexel is hiring a Clinical Trial Coordinator to support the Clinical Research Manager and study team throughout the study life cycle, from start-up through closure. The role supports trial and site administration, document management, regulatory submissions, budgeting and payments, and meeting planning.

Responsibilities

• 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
• 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
• 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
• 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
• Organize meetings (create & track study memos/letters/protocols)
• Support local investigator meetings (invitations, prepare materials, select venue, support where applicable)
• 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

• Candidates should 1-2 years of experience in clinical research
• 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
• Minimum 1-2 years in Clinical Research or relevant healthcare experience Note - Specific experience requirements may vary depending on the Country
• Or equivalent healthcare experience
• Bachelor's degree (Life Sciences preferred)

Benefits

• Remote work

Company Overview

Company H1B Sponsorship