Senior 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.

We are headquartered in Scottsdale, AZ, but this opportunity is a fully remote position!

Position Summary

The Senior 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. Supports and mentors Clinical Trial Associates in collaboration with Project Management leadership. This position reports to management within the Project Management department.

Essential Functions

• Schedule and maintain organization of all clinical project meetings.
• Assist with the development and implementation of clinical policies and procedures.
• 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.
• Gather, track, and maintain project and site essential regulatory documents.
• Accurately update and maintain clinical systems within the appropriate project timeline.
• Draft project plans and create project documents for review prior to Sponsor review, as assigned.
• Mentor and assist with training of Clinical Trial Associates.
• Acts as Clinical Trial Associate back-up during absences as needed based on individual trial needs.
• 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.
• 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.
• Perform other related duties as assigned.
• Provide cross-functional project support to entire Clinical Project team.
• Prepare, handle, distribute, file, and archive clinical documentation and reports in a timely manner.
• 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).
• 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.

Job Requirements

• Minimum of four years of experience in an administrative role.
• 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)
• At least four 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
• Experience managing Trial Master Files and/or Investigative Site Files.
• Knowledge of GCP, ICH guidelines and clinical trial regulations
• Ability to work collaboratively in a team environment.
• 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.

Compensation: From $58,000.00 to $70,000.00 per year