Job Description

• Title: Sr. Clinical Trial Associate
• Location: Parsippany, NJ
• Pay Range: $50-55/hr

Key Responsibilities:

• Support CTMs in managing critical study deliverables including start-up activities, regulatory and study document preparation, clinical supply readiness, site communications, and study closeout.
• Assist in the creation, review, and maintenance of essential trial documents such as protocols, CRFs, ICFs, regulatory binders, and training materials.
• Help coordinate cross-functional communications and support the preparation of meeting agendas, minutes, and study reports.
• Maintain and audit the electronic Trial Master File (eTMF) to ensure documentation accuracy and compliance with SOPs, GCP, and ICH guidelines.
• Facilitate site readiness for activation and enrollment by overseeing the availability of regulatory documents and site supplies.
• Serve as a liaison for sites and monitors, providing timely responses to queries and escalating issues per protocol.
• Assist in audit and inspection readiness and ensure completeness of clinical documentation.
• Help organize and participate in Investigator Meetings and other trial-specific training sessions.
• Monitor recruitment progress and site performance using systems like IRT and EDC; compile and share related metrics with the project team.
• Partner with internal teams (Legal, Finance, Procurement) to manage agreements and review site/vendor invoices.
• Track document distribution, collection, and status related to trial milestones and timelines.
• Support IRB submission and approval processes, offering hands-on guidance to sites as needed.
• Contribute to trial communications to ensure consistent information flow among internal teams, sites, and CROs.
• Participate in the review and revision of departmental SOPs and support onboarding and mentorship of junior CTAs.
• May lead select projects under the supervision of a CTM, depending on experience and performance.

Qualifications & Experience:

• Bachelor’s degree or equivalent work experience required.
• 2–4 years of relevant experience in health sciences, with at least 1–2 years in clinical research or the pharmaceutical industry.
• Strong understanding of clinical research processes, ICH-GCP, FDA regulations, and awareness of international regulatory guidelines (e.g., EMA, MHRA, PMDA).
• Proficiency with Microsoft Office (Outlook, Word, Excel, PowerPoint).
• Familiarity with electronic data capture systems, IRT/EDC platforms, and tracking systems.
• Strong communication skills (written and verbal) and ability to collaborate in cross-functional environments.
• Experience with training, mentoring, or presenting to teams is a plus.

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