Clinical Trial Associate

We are the leading oncology CRO developing novel treatments for patients that need them most. Our team is fully dedicated to oncology – it is all we do – combining innovation and expertise to quickly move medicines from preclinical development into clinical trials. Adaptive and forward-thinking – we guide our client's therapy through the most critical development milestones from the lab to planning their regulatory and clinical strategy. Our ultimate goal? To help patients.

Position Summary:

The Clinical Trial Associate (CTA) coordinates activities on clinical research trials by working with the appropriate clinical teams (e.g. Project Management Clinical Monitoring Data Management Medical Monitoring) on trial related activities.

Essential Functions:

• General:

  • Accurately update and maintain clinical systems within the appropriate timeline.

  • Acts as Clinical Trial Associate back-up during absences as needed based on individual trial needs.

• Trial:

  • Draft trial plans and create trial documents for review prior to Sponsor review as assigned.

  • Act as a central contact for the clinical team for designated trial communications meeting coordination meeting minutes correspondence and associated documentation.

  • Work with project management team on coordination of the trial including participation on Sponsor and Investigator calls maintaining trial trackers and communicating on behalf of the PM and CTM to the Sponsor investigative sites and vendors as appropriate.

  • Schedule and maintain organization of all Sponsor facing clinical trial meetings.

  • Prepare and distribute agendas and minutes from Sponsor and Investigator team meetings with review from the project management team for accuracy within established deadlines.

  • Collect and submit documents for Trial Master Files (TMF) per standard guidelines to ensure continual TMF maintenance in an audit-ready state. Routinely perform TMF document Quality Checks (QCs).

  • Prepare handle distribute file and archive clinical documentation and reports in a timely manner.

  • Maintain accurate team contact lists for every assigned trial proactively gathering information and updating the contact list. Ensure that the contact list is uploaded to the TMF as required to meet TD2 timelines.

  • Provide cross-functional trial support to entire Clinical Trial team.

• Site Management: • Gather track and maintain trial and site essential regulatory documents post site-activation. • Prepare and compile trial related materials for investigative sites including trial procedure manuals and trial templates forms and plans.

• Perform other related duties as assigned.

Job Requirements:

• Associate’s degree in a life science or health related field is preferred. Experience may be substituted for education at TD2’s discretion.

• Minimum of 2 years of experience in an administrative role.

• Minimum of 2 years of experience in support of clinical research with preference to oncology research.

Required Specialized/Technical Skills:

• Proficiency with Microsoft Office applications including Word Excel PowerPoint and Outlook.

• Strong written and verbal communication skills.

• Knowledge of GCP ICH guidelines and clinical trial regulations.

• Ability to efficiently manage time.

• Strong organizational skills.

• Ability to work collaboratively in a team environment.

TD2 is an equal opportunity employer and does not discriminate on the basis of race color national origin creed disability veteran’s status gender sexual orientation gender identity or gender expression.

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