Clinical Trial Associate Position Available In Mercer, New Jersey

Job Title:

Clinical Trials Administrative Support Specialist Job Description Join a professional, customer-focused pharmaceutical company as a Clinical Trials Administrative Support Specialist. This role involves supporting the maintenance of study records and coordinating study activities. You will develop, maintain, and archive files and records related to multiple clinical trials while providing administrative support. This position offers a competitive salary and a full benefits package. Responsibilities Work with the Project Management team to assist in planning investigator meetings. Develop required materials, including training tools. Initiate contract/budget requests, track status, and negotiate budgets with sites and vendors if necessary. Participate in vendor selection and management. Identify changes in the scope of work. Formulate, track, measure, and maintain a project-specific matrix and timelines. Schedule and manage agenda updates and meeting minutes for project team meetings. Develop monthly reports, newsletters, and communication trackers. Provide administrative support such as mass site communication distribution, shipping, filing, tracking, and summarization. Assist in the clinical trial insurance process by tracking approvals, revisions, and renewals of certificates. Maintain and track all project-specific invoices. Ensure a smooth site start-up process prior to Site Initiation Visits. Assist the Clinical Operations team with maintaining the trial master file, study site records, and files. Review essential study documents. Develop project-specific procedural documents as needed. Prepare and ship IRB/EC dossiers. Assist the study team with training and access management for CTMS and other trial-related applications. Prepare for study-specific audits and inspections. Perform other duties as assigned by senior management. Essential Skills Proficient in Microsoft Office (Word, Excel, PowerPoint). Well-organized with strong attention to detail. Excellent verbal and written communication skills. Fluent in English; other languages are a plus. Ability to work independently and with flexibility to accommodate international meeting schedules. Strong interpersonal skills. Additional Skills & Qualifications Minimum of an associate’s degree; bachelor’s degree preferred. Previous experience in a healthcare company. Experience with trial master file maintenance, auditing, and reconciliation preferred. Experience with archival of paper files and auditing archived files. Meeting agenda and minute-taking experience. Experience interacting with Contract Research Organizations and third-party vendors. Experience with Electronic Trial Master File systems. Experience in clinical trial management systems.