Job Overview
Location
Durham, North Carolina
Job Type
Full-time
Category
Product Management
Date Posted
June 23, 2026
Full Job Description
đź“‹ Description
- • Manage research activities at clinical trial sites participating in Worldwide’s psychiatric studies, ensuring adherence to protocol, regulatory requirements, and Good Clinical Practice (GCP) standards
- • Conduct all stages of clinical study execution, including identification and selection of potential investigational sites for psychiatric trials
- • Perform study start-up activities such as collecting and verifying regulatory documentation from sites, supporting contract and budget negotiations, and ensuring site readiness
- • Conduct Study Initiation Visits (SIVs) to train site staff on protocol-specific procedures, data collection methods, and safety reporting requirements
- • Monitor site performance during study maintenance, including review of source documents, case report forms, and adverse event reporting for psychiatric patient populations
- • Ensure compliance with informed consent processes, safety event reporting, and all applicable FDA, EMA, and ICH guidelines specific to psychiatric clinical research
- • Perform remote site monitoring activities as the primary mode of oversight, with occasional regional travel required for on-site visits
- • Collaborate with internal teams including Clinical Trial Managers, Regulatory Affairs, and Data Management to ensure timely and accurate data submission and trial progress
- • Maintain accurate and complete Trial Master File (TMF) documentation for psychiatric studies, coordinating with site staff and internal CRAs as needed
- • Provide ongoing support and guidance to clinical sites on protocol amendments, regulatory updates, and data query resolution
- • Utilize CTMS and EDC systems to track site activation status, monitor enrollment metrics, and report study milestones
- • Work independently with minimal supervision while maintaining high standards of accuracy, timeliness, and regulatory compliance
- • Participate in regular coaching and development conversations with Line Manager to support career progression toward Clinical Trial Manager roles
- • Contribute to a collaborative, inclusive team culture focused on advancing psychiatric research and improving patient outcomes
- • Adhere to Worldwide’s commitment to quality, innovation, and ethical conduct in all aspects of clinical trial operations
🎯 Requirements
- • 2–5 years of experience as a regional, traveling Clinical Research Associate
- • 4-year university degree OR Nursing Degree
- • Experience in psychiatric monitoring is required
- • Willingness to travel regionally required
- • Proficiency in Microsoft Office, CTMS, and EDC systems
- • Excellent interpersonal, oral, and written communication skills in English
🏖️ Benefits
- • Annual salary range of $79,500.00–$158,500.00 based on experience, performance, and education
- • Competitive benefits package tailored to location
- • Clear career path with opportunities to advance to Clinical Trial Manager roles
- • Access to supportive, team-oriented environment with accessible leadership
- • Commitment to pay equity, transparency, and compliance with labor laws
- • Inclusive workplace culture that values diversity and professional growth
Skills & Technologies
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About Worldwide Holdings Corporation
Worldwide Holdings Corporation is a diversified global enterprise engaged in the development, manufacturing, and marketing of a wide range of products and services. The company operates across various sectors, including technology, consumer goods, and industrial solutions, with a strong focus on innovation and sustainability. Worldwide Holdings Corporation is committed to delivering high-quality products and exceptional customer service, aiming to foster long-term relationships with its clients and stakeholders. The company's strategic vision involves expanding its global reach, investing in research and development, and adapting to evolving market demands to maintain a competitive edge in the international marketplace. Their mission is to create value through responsible business practices and a dedication to excellence.
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