In-House Clinical Research Associate – Contract

🔥 14 hours ago

🇺🇸 United States – Remote

💵 $60 - $70 / hour

⏳ Contract/Temporary

🟢 Junior

🟡 Mid-level

🧪 Clinical Research

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 Ghost score 0%

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4D Molecular Therapeutics

WebsiteLinkedInAll Job Openings

51 - 200 employees

💼 Consulting

🏭 Manufacturing

🧬 Biotechnology

Consulting • Manufacturing • Biotechnology

4D Molecular Therapeutics is a clinical stage biopharma company inventing and developing innovative products to unlock the full potential of genetic medicine, aiming to treat both large market and rare diseases. Utilizing its Therapeutic Vector Evolution platform, the company leverages directed evolution to create customized AAV vectors with superior therapeutic profiles. With a diverse pipeline including five product candidates in clinical trials targeting seven patient populations, 4DMT is committed to addressing challenges in genetic medicine and pursuing potential curative therapies while fostering a collaborative and innovative environment.

📋 Description

• Support day-to-day execution of a Phase 3 clinical trial across study start-up, conduct, and close-out • Serve as a primary contact for assigned clinical sites and CRO field CRAs/monitors • Communicate with sites and CRO partners to obtain updates, resolve issues, and support study timelines • Support site initiation, ongoing site management, and site close-out activities • Identify, document, track, and follow up on site issues • Support oversight of CRO monitoring activities • Review monitoring visit reports and follow up on action items and unresolved findings • Track monitoring deliverables and escalate issues to the Associate Director, Clinical Operations • Support inspection readiness and audit activities • Maintain study tracking tools covering site activation, enrollment, visits, essential documents, TMF status, and vendor reconciliation • Prepare study status reports and metrics • Collect, review, and track site regulatory documents • File documents in the TMF/eTMF and perform TMF quality control • Support TMF audits and study close-out • Coordinate internal, investigator, and study-related meetings • Prepare meeting materials, take minutes, and maintain action item logs • Communicate study updates to internal stakeholders • Support ad hoc Clinical Operations projects

🎯 Requirements

• A. or B.S. degree required • Minimum of 1-2 years of experience supporting clinical trials in a sponsor or CRO environment • Working knowledge of clinical trial operations and ICH GCP guidelines • Experience with TMF/eTMF systems (Veeva Vault preferred) • Proficient in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook) • Strong organizational skills and attention to detail • Ability to manage multiple priorities and meet deadlines • Strong interpersonal skills and ability to collaborate effectively with cross functional teams and external partners • Willingness to travel as business needs demand (<5% anticipated) • Sedentary work capacity, including occasional exertion of up to 10 pounds • Ability to perform repetitive wrist, hand, finger, typing, and talking activities

🏖️ Benefits

• Equal employment opportunities • <5% anticipated travel (travel support/participation)