Clinical Trial Coordinator – FSP

🔥 0 minutes ago

🇺🇸 United States – Remote

⏰ Full Time

🟢 Junior

🚫👨‍🎓 No degree required

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 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 other team members throughout the study life cycle, from study start-up to study closure • Track essential documents and report safety reports • Collate and distribute study tools and documents • Update clinical trial management systems (CTMS) and trackers • Manage clinical and non-clinical supplies in collaboration with country roles • Manage labeling requirements and coordinate translation change requests • Prepare, distribute, ship, archive, and quality-control clinical documents • Assist with electronic Trial Master File (eTMF) reconciliation and execute the eTMF Quality Control Plan • Prepare Investigator Trial File binders and update manuals and documents • Obtain translations and document proper destruction of clinical supplies • Provide and collect investigator forms/lists for site evaluation, validation, start-up, and submissions • Obtain, track, and update study insurance certificates • Support IRB/Ethics Review Committee submission packages and regulatory agency submissions • Publish study results where required by local legislation • Collaborate with finance/budgeting representatives on country and site budgets, negotiations, tracking tools, contracts, payments, financial compliance, disclosures, and budget closeout • Obtain 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 logistics • Complete assigned Client and Parexel training and adhere to SOPs and processes • Contribute to team knowledge by mentoring/buddying and sharing best practices

🎯 Requirements

• B.A./B.S. (Life Sciences preferred) or equivalent healthcare experience • Minimum 1-2 years in Clinical Research or relevant healthcare experience • 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, including use of MS Office and clinical IT applications; strong MS Excel skills required • International Committee on Harmonization (ICH) Good Clinical Practice (GCP) 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 establish culturally sensitive working relationships • Ability to work independently • Proactive attitude toward solving problems and proposing solutions • Fluent in local languages and business proficient in English, verbal and written • Excellent communication skills