Clinical Trial Coordinator – FSP

🔥 0 minutes ago

🇺🇸 United States – Remote

⏰ Full Time

🟢 Junior

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Parexel

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1983

💼 Consulting

🏥 Healthcare

📦 Logistics

💰 Venture Round on 1990-01

Consulting • Healthcare • Logistics

Parexel is one of the world's largest clinical research organizations (CROs), providing comprehensive services for the clinical development process from Phase I to IV. The company specializes in portfolio management, clinical trial management, regulatory strategy, market access, and lifecycle management for biopharmaceuticals. Parexel aims to speed life-changing medicines to market by leveraging its clinical, regulatory, and therapeutic expertise. With a global team of over 21,000 professionals, Parexel works to integrate patient insights and innovative trial designs to develop treatments across therapeutic areas such as oncology, neuroscience, rare diseases, and more. It focuses on delivering patient-centric and efficient clinical trials.

📋 Description

• Support the Clinical Research Manager and other team members throughout the study lifecycle from study start-up to study closure • Track essential documents and report safety reports • Collate and distribute study tools and documents • Update clinical trial databases and trackers • Manage clinical and non-clinical supplies in collaboration with country roles • Manage labeling requirements and coordinate/sign translation change requests • Prepare, collate, distribute, ship, and archive clinical documents and correspondence • Assist with electronic Trial Master File reconciliation and execute the electronic Trial Master File Quality Control Plan • Update manuals and documents and obtain document translations • Document proper destruction of clinical supplies • Prepare Investigator trial file binders • Provide and collect investigator forms/lists for site evaluation, validation, start-up, and submissions • Obtain, track, and update study insurance certificates • Support Institutional Review Board/Ethics Review Committee and regulatory agency submissions • Publish study results where required by local legislation • Develop country and site budgets and track negotiations • Maintain tracking tools and contract templates • Support contract development, negotiation, approval, and maintenance • Calculate and execute payments to investigators, vendors, and grants • Ensure compliance with financial procedures and track adherence and disclosures • Complete budget closeout and process Foreign Corrupt Practices Act documentation • Organize meetings and support local investigator meetings • Complete required training, timesheets, expense reports, and CV updates • Maintain compliance with Parexel processes, ICH-GCP, and applicable requirements • Contribute to team knowledge by mentoring and sharing best practices

🎯 Requirements

• Candidates should have 1-2 years of experience in clinical research • Fluent in Local Languages and business proficient in English (verbal and written) • Good understanding of Global, Country/Regional Clinical Research Guidelines • Hands on knowledge of Good Documentation Practices • Good IT skills, including MS Office and clinical IT applications • Strong MS Excel skills • International Council for Harmonization – Good Clinical Practice knowledge appropriate to role • Effective time management, organizational, interpersonal, and conflict management skills • Effective communication with external customers, including sites and investigators • Ability to set priorities and handle multiple tasks simultaneously in a changing environment • Ability to work effectively in a matrix multicultural environment and maintain culturally sensitive working relationships • Able to work independently • Proactive attitude to solving problems and proposing solutions • Bachelor’s degree (Life Sciences preferred) or equivalent healthcare experience