Clinical Trial Associate

Role overview

Skyhawk Therapeutics is hiring a Clinical Trial Associate to support Clinical Operations with a mix of administrative, coordination, and study-management tasks. This position is based in Waltham, MA and is intended for someone who can work effectively in a fast-moving biotech environment.

Key responsibilities

• Set up and maintain meeting agendas and minutes for internal team meetings as well as cross-functional discussions, and review external meeting minutes when needed.
• Partner with clinical consultants to coordinate study logistics, follow progress, and support operational tasks such as study plan review and eTMF checks.
• Keep internal tracking tools current, including enrollment, investigator engagement, and bioanalytical sample trackers, and turn those updates into presentations or reports when requested.
• Manage Clinical Operations study files and periodically reconcile documents so records are complete, accurate, and properly versioned.
• Build and update contact lists for study personnel and key opinion leaders across disease areas.
• Review study documents such as protocols, investigator brochures, and informed consent forms.
• Support planning and execution of external meetings, including Clinical Advisory Board meetings, by handling outreach, scheduling, confidentiality agreements, contracts, travel, presentations, agendas, and minutes.
• Track bioanalytical samples and coordinate with central and third-party laboratories on shipment and analysis timelines.
• Review laboratory-related materials such as lab manuals and site flowcharts.
• Monitor trip reports across the program and help ensure follow-up items are tracked.

Requirements

• A relevant educational background and training are required; a bachelor’s degree in an administrative, scientific, or medical field is considered an advantage.
• At least 2 years of successful administrative experience in biotech or life sciences.
• Comfort working independently with minimal supervision while also contributing as a collaborative team member.
• Strong organization skills and the ability to handle several priorities in a changing, fast-paced setting.
• Excellent spoken and written communication abilities.
• Strong computer proficiency, especially with Microsoft Office tools such as Calendar, Word, Excel, and PowerPoint; experience with SharePoint and SmartSheet is preferred.
• Working knowledge of Veeva TMF.
• Proven ability to multitask and manage projects effectively.

Compensation

The position offers a base salary range of USD 100,000 to 130,000 per year. Final compensation will depend on relevant skills, experience, and education.

About the company

Skyhawk Therapeutics focuses on discovering, developing, and commercializing small-molecule therapies that influence RNA expression. Its SkySTAR platform is used to advance drug candidates for difficult-to-treat diseases, including neurological disorders, cancer, and other traditionally hard-to-target areas.