Clinical Trial Coordinator (Regulatory) - FSP

Parexel; United States; À distance; USD 55 000 - 75 000; Plein temps

Résumé du poste

Parexel is seeking a Clinical Trial Coordinator to join our US-based team. The role supports the Clinical Research Manager through the life cycle of studies, from startup to closure, with 1–2 years of clinical research experience preferred.

Responsibilities include trial and site administration, document management, regulatory support, budgeting, meetings, and ensuring compliance with Parexel processes. Strong English, IT skills, and organization are essential.

Qualifications

• 1–2 years of clinical research or relevant healthcare experience.
• Fluent in English and local languages; strong communication skills.

Responsabilités

• Tracking (e.g., essential documents) and reporting (e.g., Safety Reports)
• Update clinical trial databases and trackers
• Prepare documents and correspondence
• Collate, distribute/ship, and archive clinical documents
• Execute electronic Trial Master File Quality Control Plan
• Obtain translations of documents
• Development of country and site budgets (including Split site budget)
• Payment calculation and execution (investigators, vendors, grants)
• Organize meetings (create & track study memos/letters/protocols)
• Complies with Parexel standards and ICH-GCPs

Connaissances

Fluent English

MS Excel

Good IT skills

Time management

Communication skills

GCP knowledge

Formation

Bachelor’s degree (Life Sciences preferred) or equivalent healthcare experience

Description du poste

Parexel FSP is seeking Clinical Trial Coordinators to join our team in US! Candidates should 1-2 years of experience in clinical research.

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-Remote

#LI-REMOTE EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.