Job Description

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

Essential Functions:

• Draft project plans and create project documents for review prior to Sponsor review, as assigned.
• Act as a central contact and provides expert guidance to the clinical team for designated project communications, meeting coordination, meeting minutes, correspondence, and associated documentation.
• Coordinate activities on clinical trials, including active participation on weekly Sponsor and Investigator calls, maintaining project trackers, and communicating on behalf of the PM to the Sponsor, investigative sites, and vendors as appropriate.
• Schedule and maintain organization of all clinical project meetings.
• Accurately update and maintain clinical systems within the appropriate project timeline.
• Collect and submit documents for assigned 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.
• Prepare and distribute agendas and minutes from Sponsor and Investigator for team meetings with review from the project management team for accuracy within established deadlines.
• Maintain accurate team contact lists for every assigned project, proactively gathering information, and updating the contact list. Ensure that the contact list is uploaded to the TMF, as required to meet Standard Operating Procedure timelines.
• Gather, track, and maintain project and site essential regulatory documents.
• Provide cross-functional project support to entire Clinical Project team.
• Prepare and compile trial related materials for investigative sites, including Investigator Site File (ISF) materials, site electronic binders, site instruction manuals, and trial templates, forms, and plans.
• Acts as Clinical Trial Associate back-up during absences as needed based on individual trial needs.
• Mentor and assist with training of Clinical Trial Associates.
• Assist with the development and implementation of clinical policies and procedures.
• Perform other related duties as assigned.

Job Requirements:

• Associate degree in a life science or health related field required with Bachelor’s degree preferred (experience working in clinical research may be substituted for education at TD2’s discretion)
• Minimum of 4 years of experience in an administrative role.
• At least 3 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.
• Advanced written and verbal communication skills
• Knowledge of GCP, ICH guidelines and clinical trial regulations
• Ability to work collaboratively in a team environment.
• Experience managing Trial Master Files and/or Investigative Site Files.
• Ability to take initiative and work independently with minimal guidance.

Born from the Translational Genomics Research Institute (TGen), TD2 was formed in 2003 as a subsidiary of TGen, and less than two years later, opened its doors on the campus of the Mayo Clinic in Scottsdale, Ariz. In our 17 years of business, we have helped more than 600 biotech and pharma companies, maintaining hundreds of client studies per year. Among them, our team has been involved in more than 600 first-in-man major oncology medicines, including numerous trials that have led to approvals in both rare and large indications.

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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