Clinical Trial Associate

The Clinical Trial Associate (CTA) role provides administrative and organizational support to the internal clinical project team as well as assigned clinical investigative sites. The CTA will perform key job functions in accordance with ICH/Good Clinical Practice (GCP) guidelines, FDA regulations, LumaBridge SOPs and work practices, while supporting the organizational mission to advance the development of promising oncology therapies and technologies to benefit patients.

The Senior CTA will also provide Clinical Operations departmental support with process improvement, training of staff and serve as a mentor to other CTAs.

Reports To: Associate Director or Director, Clinical Operations or designee.

Title(s): Clinical Trial Associate

Senior Clinical Trial Associate

Location: This is a home-based position. Potential for travel < 10%.

Responsibilities:

• Serve as internal support to members of assigned project teams.
• Assist investigative sites with completion and IRB submission of required essential and study documents from study start-up throughout the life cycle of the study.
• Initiate and facilitate the completion of the Investigational Product (IP) Authorization Checklist.
• Maintain timely and accurate tracking within Clinical Trial Management System (CTMS), as defined by the study, such as Study Contacts, Start-up Tracking.
• Assist Clinical Lead (CL) with compilation of monthly Sponsor status reports, as requested.
• Support establishment, maintenance and delivery of Trial Master Files (TMF) for assigned clinical studies.
• Perform TMF Quality Control (QC) reviews of both study and site levels, per the TMF Plan.
• Ensure audit/inspection readiness of assigned study’s TMF throughout the lifecycle of the study, which includes timely document filing, per the TMF Plan.
• Coordinate central Institutional Review Board (IRB) submissions, annual reviews and closure notifications, as appropriate.
• Support overall progress of the assigned study by attending internal and Sponsor study team meetings, preparing meeting agendas/minutes, maintaining documentation of project team training, reviewing team communications and sharing pertinent information with study team members and investigative sites, as requested.
• Assist with Clinical Study Report activities, such as compilation of appendices.
• Maintain positive interactions with internal and external stakeholders, including investigative site staff, Sponsor representative(s) and vendors, as appropriate.
• Assist with Investigator payment process based upon knowledge of site activities obtained from EDC, IXRS and CTMS tracking.
• Support the successful execution of assigned tasks in compliance with ICH/GCP standards, FDA regulations, LumaBridge SOPs and guidance documents.
• Supports the organization with administrative tasks as requested.
• Assist with audit preparation, as requested.
• Assist with other duties as assigned.

Senior Clinical Trial Associate:

• Provides training to new and/or existing CTA staff, as requested.
• Acts as mentor to CTA staff.
• Support and lead department initiatives, such as process improvement and creation of guidance reference documents or updating template(s).

Qualifications/Skills:

• Bachelor degree, preferably in life science, or equivalent experience required,
• Minimum 1 year experience as CTA at a CRO or Sponsor.
• Ability to problem-solve, multi-task and prioritize across tasks.
• Fluent in English (written and verbal).
• Detail oriented
• Strong communication (written and verbal) and interpersonal skills.
• Proficient in Microsoft suite of applications Office.
• Working knowledge of ICH GCPs and FDA regulations.
• Ability and willingness to travel domestically as required (i.e. <10%).
• Ability to work from a remote environment with minimal supervision.
• Willingness to adapt to the use of new technologies.

Senior CTA:

• Minimum 3 years of industry experience.
• Demonstrates initiative, self-starter, leadership skills and abilities.
• Proficient in development of documents/plans with limited oversight required.
• Willingness and ability to present to an audience as requested.