Clinical Trial Coordinator – FSP

🔥 1 minute ago

🇺🇸 United States – Remote

⏰ Full Time

🟢 Junior

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👻 Ghost score 10%

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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 team members throughout the study lifecycle from start-up to 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 with country roles • Manage labeling requirements and coordinate translation change requests • Prepare, collate, distribute, ship, archive, and quality-control clinical documents • Assist with electronic Trial Master File reconciliation • Update manuals and documents and document destruction of clinical supplies • Prepare Investigator trial file binders • Obtain document translations • Provide and collect investigator forms and lists for site evaluation, start-up, and submissions • Obtain, track, and update study insurance certificates • Support Institutional Review Board/Ethics Review Committee and regulatory 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 grant recipients • Ensure compliance with financial procedures and track adherence and disclosures • Close out budgets and process Foreign Corrupt Practices Act documentation • Organize meetings and study memos, letters, and protocols • Support local investigator meetings, including invitations, materials, venue selection, and on-site support

🎯 Requirements

• Minimum 1-2 years Clinical Research experience • Bachelor’s degree (Life Sciences preferred) or equivalent healthcare experience • 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 • Ability to work effectively in a matrix multicultural environment • Ability to work independently and prioritize multiple tasks • Customer-focused, proactive, and positive mindset • Ability to establish culturally sensitive working relationships • Commitment to sharing best practices and mentoring as appropriate