Associate Clinical Project Manager

Cook Medical - West Lafayette, IN

Full-time - Entry Level

West Lafayette, IN

Merchant Wholesalers, Durable Goods

About the position

The Associate Clinical Project Manager (ACPM) position at Cook Research Inc. is designed to support the management of daily operational and logistical activities of clinical studies. The role involves assisting the clinical team in achieving milestones and deliverables, managing investigational device logistics, and ensuring compliance with regulatory standards. The ACPM will collaborate closely with study teams to facilitate communication and prioritize tasks effectively.

Responsibilities

• Work closely with the clinical study team to ensure timely study activities and compliance with quality system procedures.
• Assist in preparing clinical studies for audit-readiness by reviewing key documents for compliance with regulatory authority criteria.
• Develop and maintain knowledge of best practices for quality review of documents uploaded to the Clinical Document Management System.
• Provide assistance with query management and maintain knowledge of local and global regulatory requirements.
• Prepare, distribute, and file study materials such as patient binders and investigator files.
• Assist in preparing and coordinating internal meetings and external clinical study meeting logistics.
• Attend study team meetings, take notes, and assist in generating meeting minutes.
• Prepare for monitoring visits by reviewing electronic trial master files (eTMF/CTMF).
• Perform electronic data capture (EDC) administrative tasks as needed.
• Assist the Clinical Project Manager (CPM) with site and study-related documents and reports throughout the study lifecycle.
• Manage clinical study insurance, if applicable, and lead investigational device logistics locally and globally.
• Facilitate site selection activities and maintain documentation to support the selection of clinical sites and Principal Investigators.
• Ensure all clinical study documentation is audit-ready and provide support for other clinical study activities as needed.

Requirements

• Associate's/Bachelor's degree in a scientific, health, or business-related field or equivalent work experience.
• Previous experience in supporting research or medical device/drug clinical studies is preferred.
• Strong work ethic and personal discipline with the ability to work independently.
• Ability to work in a team atmosphere and communicate constructively with colleagues.
• Good computer skills with an aptitude for learning new software platforms.
• Experience with Microsoft Office tools (Word, Excel, PowerPoint).
• High level of accuracy and attention to detail.
• Strong organizational skills and time management abilities to handle multiple projects.
• Excellent critical thinking, written, and verbal communication skills.
• Willingness to travel as needed.

Nice-to-haves

• Experience with clinical trial management systems (CTMS).
• Familiarity with electronic data capture (EDC) systems.

Benefits

• Health insurance
• 401k retirement plan
• Paid time off
• Professional development opportunities