Senior Clinical Trial Associate

General Summary

4DMT seeks a motivated and experienced Senior Clinical Trial Associate to support the Company's clinical trial activities. This position reports to the Sr. CTM, Clinical Operations and will be responsible for supporting the day-to-day operations of a phase 3 clinical trial including trial start up, conduct and close-out activities. This role requires strong, professional written and verbal communication skills, good organization and attention to detail, and the ability to consistently provide high quality work while managing competing priorities and maintaining tight timelines. This person must be interested in working in a fast-paced, team-oriented environment and be willing to work beyond their job scope to achieve department and company objectives.

MAJOR DUTIES & RESPONSIBILITIES

Tracking All Aspects and Activities of a Clinical Trial:

• Collect, track and conduct initial review for completeness of site regulatory documents for IP release and/or TMF filing
• Maintain multiple tracking spreadsheets following the progress of assigned clinical trials, such as study subject tracking, essential document tracking, and sample and investigational product tracking
• Track and coordinate CRO and third-party vendor activities, including vendor provided meeting minutes, study updates and trackers
• Assist with tracking of clinical trial progress including status update reports, as requested
• Assist in tracking of trial IP
• Assist in tracking of clinical lab samples and central reader/lab data, including tracking of sample shipments and reconciliation
• May assist CTM in tracking and follow-up of monitoring visit reports and unresolved issues

Contracts and Finance Activities:

• Facilitate review and execution of new CDAs, contracts and Work Orders through established legal approval process (CTAs, MSAs, work/task orders)
• Perform first pass review of all site and vendor invoices including tracking and generation of monthly/quarterly accruals for finance

Clinical Trial Communications:

• Communicate directly with sites, Contract Research Organizations (CROs) and field CRA/monitors to obtain updated information, essential documents, etc. to assist with driving start-up, study conduct, and/or close-out activities
• Assist with the organization, management and conduct of internal team meetings, investigator meetings and other trial-specific meetings, including minute taking and action item log tracking

Document Review and Quality Control:

• Receive and review all regulatory documents from sites (direct or through CRO) for accuracy and compliance to applicable SOPs and regulatory guidelines
• Ensure timely updates are provided to CTM for updating of ‘Clinicaltrial.gov’ (site updates/changes)
• Assist with the development of site tools and clinical trial start-up activities
• Assist and/or contribute to the creation and maintenance of study materials for clinical studies, including but not limited to site and CRA training material, regulatory document templates, study binders, study plans/manuals, study communications and presentations
• Organize, maintain and participate in audits and close out of the Trial Master File (TMF/eTMF)

Miscellaneous Activities:

• Participate in the EDC specification and user acceptance testing processes, as appropriate
• Other duties may be assigned
• Willingness to travel as trial needs demand (<5% anticipated)

QUALIFICATIONS

Education:

• A./B.S. degree required

Experience:

• At least 2 years of work experience supporting clinical trials

Other Qualifications/Skills:

• Must be proficient with TMF and Veeva Vault
• Proficient computer skills, specifically with Microsoft Office Suite that include Word, Excel, PowerPoint, and Outlook
• Ability to prioritize and manage competing priorities
• Team oriented and ability to effectively collaborate with study team, cross-functional team members, and external partners
• Basic knowledge of clinical trial operations, ICH GCP Guidelines and other applicable regulatory requirements

Key skills/competency

• Clinical Trial Management
• Regulatory Document Review
• TMF/eTMF Management
• Veeva Vault
• ICH GCP Guidelines
• Vendor Coordination
• Trial Start-up & Close-out
• Clinical Operations
• Data Tracking
• Microsoft Office Suite