What are the responsibilities and job description for the Clinical Trial Associate position at Joulé?
Location: Plainsboro , New Jersey
Type: Contract - 6 month renewable
Contractor Work Model: Hybrid - Plainsboro, NJ
Leading Pharmaceutical Company located in NJ is hiring a Clinical Trial Associate w/ 5 years industry experience. If you want to be a part of this groundbreaking work, please apply!
Job Description
The Clinical Trial Associate will support Clinical Trial Managers and Clinical Trial Teams (CTTs) in managing and executing clinical trials to ensure compliance with Good Clinical Practice (GCP), regulatory requirements, and internal standards. The role requires strong attention to detail, cross-functional collaboration, and flexibility to work across global time zones.
Roles & Responsibilities
Trial Planning and Oversight
- Develop and manage operational plans, charters, and manuals to support trial execution in compliance with regulatory and internal standards.
- Review protocols and protocol amendments.
- Coordinate and update the Trial Oversight Plan.
- Review Investigator’s Brochure from a development operations perspective.
- Review Clinical Trial Application submission packages and support responses to Health Authority questions.
- Review Regulatory Green Light packages.
- Review Development Safety Update Reports.
- Develop the Global Master Informed Consent Form (ICF).
- Serve as key liaison between internal stakeholders and CROs, overseeing sponsor oversight visits to ensure quality and compliance.
Site Selection and Management
- Collaborate with CROs and internal teams to oversee site selection based on feasibility assessments, ensuring site readiness aligns with trial timelines.
- Coordinate the review of country-specific informed consent forms with internal stakeholders.
Vendor Management and Oversight
- Monitor and manage vendor deliverables, ensuring alignment with trial goals and timelines.
- Participate in selection and approval of key CRO personnel such as Clinical Leads and trial-specific CRAs to ensure alignment with trial needs.
- Trial Execution and Monitoring
- Provide guidance on protocol deviations, assess ongoing deviations, and track trends.
- Ensure accuracy and completeness of the electronic Trial Master File (eTMF), supporting inspection readiness and regulatory compliance.
- Maintain relevant data within Clinical Trial Management Systems and related tools.
- Drive Operational Data Base reviews for the trial.
- Engage in Risk-Based Quality Management activities to improve data quality and monitoring.
- Maintain the Clinical Trial Team issue log in collaboration with the Global Clinical Trial Manager.
- Support assessment of trial-level key performance indicators (KPIs) and manage escalation processes for stakeholders.
- Participate in inspection readiness and audit preparations; conduct site visits as required.
- Oversee tracking and reconciliation of trial-related items (e.g., scans, samples) to ensure accuracy during trial closeout.
System One, and its subsidiaries including Joulé, ALTA IT Services, and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.
System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.
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Ref: #568-Clinical