Clinical Affairs Coordinator

What You Can Expect

Provides operational and administrative coordination support within an assigned Clinical Affairs function. Executes defined tasks with moderate supervision, contributing to study or project tracking, document control, and stakeholder coordination.

This is a hybrid position, 2 days on-site required per week in Warsaw, Indiana.

How You'll Create Impact

• Tracks and follows up on assigned activities within the Clinical Affairs function, escalating issues or questions to the appropriate team member as needed.
• Maintains and organizes documents, records, supplies, and files for assigned tasks in accordance with SOPs, GCP standards, and applicable regulatory requirements, ensuring accuracy and audit-readiness.
• Performs data entry, verification, and routine reporting tasks to support ongoing projects, studies, or programs within the assigned function.
• Assists with the preparation and formatting of documents, reports, or materials relevant to the assigned sub-function following established templates and guidelines.
• Communicates with internal stakeholders, external vendors, or clinical sites to facilitate the timely exchange of information, escalating issues as appropriate.
• Tracks and processes financial transactions including invoices, reimbursements, payment requests, or vendor agreements in accordance with company policies.
• Coordinates logistics for meetings, site activities, or project milestones, including preparing materials, distributing communications, and capturing action items.
• Supports process and compliance activities within the assigned function by following applicable regulations, SOPs, and internal work instructions.

What Makes You Stand Out

• Proficiency in Microsoft Office Suite and clinical or document management systems (e.g., SharePoint, EDC, CTMS, or equivalent platforms).
• Strong organizational skills with the ability to manage multiple concurrent tasks accurately and on time.
• Effective oral and written communication skills, with the ability to interact professionally with internal teams and external contacts.
• Ability to work both independently and collaboratively on assigned tasks within a cross-functional environment.
• High degree of professionalism and discretion when handling sensitive or confidential information.

Your Background

• Minimum Qualification: High School Diploma or Equivalent and 2 years of relevant experience
• Preferred Qualification: 2+ years of experience in clinical research support, healthcare operations, regulatory or quality coordination, study administration, or related project coordination role.
• Preferred Qualification: Prior healthcare or Clinical Affairs experience.
• Preferred Qualification: Experience supporting clinical trials, post-market studies, or regulatory submissions.

Travel Expectations

Up to 10%