Clinical Trial Associate

Skyhawk Therapeutics•Waltham, MA

About The Position

Skyhawk Therapeutics is seeking a highly motivated CTA to provide administrative and operational support to Clinical Operations. The role involves supporting clinical studies through various administrative and logistical tasks, ensuring proper documentation, and facilitating communication within the clinical operations team and with external stakeholders.

Requirements

At least 3-5 years of successful administrative experience in biotech/life sciences, health care or clinical study management (title commensurate with experience, with emphasis on eTMF experience)
Prefers to contribute as both independent, self-starter, and a collaborative team member.
Excellent organizational skills; prefers and can adapt to multiple priorities in a fast-paced and fluid work environment.
Excellent verbal and written communication skills.
Excellent computer skills, including Microsoft Office Suite: Calendar, Word, Excel, and PowerPoint are essential.
Demonstrated multi-tasking and project management skills.

Nice To Haves

Bachelor’s degree in administrative, science or medical areas of study is a plus.
SharePoint and SmartSheet preferred.
Veeva TMF working knowledge
For senior level, demonstrated knowledge of ICH-GCP, FDA and international regulatory requirements, eTMF management/oversight, and inspection readiness

Responsibilities

Organize, participate in, and maintain agendas and meeting minutes for all internal and cross-functional team meetings.
Review external meeting minutes as required.
Work closely with our clinical operations team to coordinate, track, and manage logistics in support of studies (e.g. review study plans, assist with eTMF reviews).
Update and maintain internal trackers (e.g. central enrollment tracker, investigator engagement tracker, bioanalytical sample tracker) and implement updates into ad-hoc presentations and reports as required.
Maintain internal Clinical Operations study files and perform periodic reconciliations of documents to ensure all material is present and versioned correctly.
Create and maintain study personnel contact lists for all studies and KOLs by disease indication.
Assist with the review of study-related documents for clinical studies (e.g. protocol, IB, ICFs).
Assist with the facilitation of important external meetings (e.g. Clinical Advisory Board meetings): outreach, scheduling, execution of CDAs and contracts, travel arrangements, presentations, agendas, and minutes.
Assist with bioanalytical sample tracking and management of central and third-party labs (sample shipment and analysis timelines).
Assist with the review of central and third-party lab documents (e.g. Lab Manual, site flowcharts).
Assist with monitoring trip report across the program.