Job Description

Clinical Trial Associate - Consultant (No third parties or C2C)

*This role is with a global pharmaceutical company located in NJ. Mandatory 3 days per week onsite*

Key Responsibilities:

• Coordinate meetings, including scheduling, agenda preparation, and minute-taking.
• Gather data for feasibility assessments and site selection, and maintain site usability records.
• Review study documents (e.g., informed consent forms, case report forms) in compliance with SOPs.
• Assemble and update study manuals and maintain version control of study materials.
• Monitor site activation, enrollment, and study progress, and escalate any issues or deviations.
• Maintain investigator and site status updates, and support clinical trial registry postings.
• Perform regular reconciliations of the Trial Master File (TMF).
• Ensure timely receipt of required reports (e.g., 1572 changes, financial disclosures).
• Manage team SharePoint or shared drive sites and maintain site contact information.
• Assist in managing third-party vendors and tracking study close-out activities.
• Participate in SOP revisions and propose process improvements.

Qualifications:

• Strong attention to detail and ability to manage study activities effectively.
• Good communication and interpersonal skills.
• Problem-solving abilities and proactive approach to tasks.
• Familiarity with trial management systems and MS Office applications.
• Basic understanding of clinical drug development and ICH/GCP guidelines.

Experience:

• Bachelor’s degree with 5+ of relevant experience

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