Clinical Trial Coordinator - FSP

Parexel; United States; Vor Ort; USD 55.000 - 85.000; Vollzeit

Zusammenfassung

Parexel is seeking a Clinical Trial Coordinator to support the Clinical Research Manager and team through the study life cycle from startup to closure. You will manage documentation, regulatory activities, budgeting, and site communications in a global matrix environment.

The role requires strong organizational and communication skills, proficiency with MS Office, and the ability to work independently while collaborating with investigators and vendors.

Qualifikationen

• Bachelor’s degree in Life Sciences or equivalent healthcare experience.
• 1–2 years of Clinical Research experience preferred.
• Strong documentation and regulatory understanding.
• Excellent communication and time management abilities.

Aufgaben

• Support study life cycle from startup to closure.
• Track essential documents and safety reports; maintain study tools and trackers.
• Coordinate regulatory submissions and site start-up activities.
• Assist with trial master file maintenance and document revisions.
• Support budgeting, agreements, and payments processes.
• Plan and organize investigator meetings and other study-related meetings.

Kenntnisse

Fluent in Local Languages

Business English (verbal and written)

Communication skills

Time management

Organizational skills

Interpersonal skills

Independent working

Problem solving

Ausbildung

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

Tools

MS Office

Clinical IT applications

Electronic Trial Master File (eTMF)

Jobbeschreibung

Job Summary

The Clinical Trial Coordinator is responsible for supporting the Clinical Research Manager and other team members through the life cycle of the study from study start up to study closure.

Job Summary

The Clinical Trial Coordinator is responsible for supporting 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)

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 Clinical Research experience

Education

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