Clinical Trial Coordinator – Regulatory

🔥 0 minutes ago

🇺🇸 United States – Remote

⏰ Full Time

🟢 Junior

🚔 Compliance

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 Ghost score 10%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

Apply Now

Find Similar Remote Jobs

Set Up Email Alert For New Jobs

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume

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 through the study lifecycle from start-up to closure • Track essential documents and report safety information • 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 translation change requests • Prepare, distribute, ship, archive, and quality-control clinical documents • Assist with electronic Trial Master File reconciliation • Prepare Investigator trial file binders • Obtain document translations • Provide and collect investigator forms for site evaluation, start-up, and submissions • Track study insurance certificates • Support Institutional Review Board/Ethics Review Committee and regulatory submissions • Publish study results where required by local legislation • Develop and track country and site budgets and negotiations • Support contract development, negotiation, approval, and maintenance • Calculate and execute payments to investigators, vendors, and grant recipients • Maintain financial compliance, disclosures, and budget closeout • Process Foreign Corrupt Practices Act documentation • Organize study meetings and support local investigator meetings • Complete required training, timesheets, expense reports, and CV updates • Comply with Parexel processes, ICH-GCP, and applicable requirements

🎯 Requirements

• 1–2 years of experience in clinical research or relevant healthcare experience • Bachelor’s degree (Life Sciences preferred) or equivalent healthcare experience • Fluent in local languages • 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 Microsoft Office and clinical IT applications • Strong Microsoft Excel skills • International Council for Harmonization – Good Clinical Practice knowledge appropriate to the role • Effective time management, organizational, interpersonal, and conflict-management skills • Ability to work independently and manage multiple tasks • Ability to work in a matrix multicultural environment • Ability to establish culturally sensitive working relationships • Proactive problem-solving attitude • Willingness to act as a buddy/mentor and share best practices

🏖️ Benefits

• Equal opportunity employment • Required training curriculum • Professional compliance and development support • Flexible remote work arrangement