Clinical Trial Associate

TalentCraft; Waltham (MA); On-site; USD 65,000 - 90,000; Full time

Job summary

TalentCraft in Massachusetts seeks a highly motivated CTA to provide administrative and operational support to Clinical Operations. You will coordinate study logistics, maintain trackers, and support eTMF reviews, ensuring documents are complete and versioned.

Ideal candidates have 3+ years of biotech or life sciences administrative experience, strong communication, and proficiency in MS Office. Familiarity with Veeva TMF and regulatory standards is a plus.

Qualifications

• Bachelor’s degree in administrative, science or medical areas is required or a plus.
• 3+ years of administrative experience in biotech/life sciences, healthcare or clinical study management.
• Demonstrated ability to work independently and as part of a team with excellent organizational skills.
• Strong verbal and written communication skills; proficient in MS Office and data tracking.
• Knowledge of Veeva TMF and regulatory requirements (ICH-GCP, FDA) is a plus.
• Proven multi-tasking and project management capabilities.

Responsibilities

• Organize and maintain agendas and meeting minutes for internal and cross-functional meetings.
• Coordinate, track, and manage logistics to support studies (eTMF review, study plans).
• Update internal trackers and create ad-hoc reports and presentations.
• Maintain study files, perform periodic document reconciliations, ensure version control.
• Create and maintain study personnel contact lists and KOLs by disease indication.
• Assist with study document reviews (protocol, IB, ICFs).
• Support external meetings: outreach, scheduling, CDAs, contracts, travel, agendas, minutes.

Skills

Administrative experience

Communication

Organization

Microsoft Office

Veeva TMF knowledge

Project management

Team collaboration

Multitasking

Education

Bachelor's degree in administrative, science or medical areas

Tools

SharePoint

SmartSheet

Microsoft Office Suite

Job description

Seeking a highly motivated CTA to provide administrative and operational support to Clinical Operations.

Responsibilities (including, but not limited to):

• 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.

Requirements, Education, Experience & Skills:

• Relevant education and training required; Bachelor’s degree in administrative, science or medical areas of study is a plus.
• At least 3+ 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. SharePoint and SmartSheet preferred.
• Veeva TMF working knowledge and for senior level, demonstrated knowledge of ICH-GCP, FDA and international regulatory requirements, eTMF management/oversight, and inspection readiness
• Demonstrated multi-tasking and project management skills.