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:

This position is responsible for management of the Clinical Monitoring department, including supervision of contract and/or direct hire Clinical Research Associates (CRAs) to ensure research trials are completed in compliance with the protocol, GCP, FDA regulations, ICH guidelines, and overall clinical objectives. As needed, this position is also responsible for performing CRA duties in managing clinical trial research sites.

Essential Functions:

• Perform CRA Management duties as follows:
  • Supervise assigned contract and/or direct hire CRAs to ensure monitoring duties are completed in compliance with the protocol, GCP, FDA regulations, ICH guidelines, and overall clinical objectives.
  • Source, select, onboard and train new CRAs.
  • Assign and manage CRA resources on clinical trials.
  • Review and approve travel expenses and invoices.
  • Measure performance for assigned CRAs, including conducting periodic surveys to assess CRA performance at clinical trial sites and performing quality control visits (co-monitoring and/or accompanied field visits).
  • Maintain template of department forms and plans related to monitoring, including the Monitoring Plan, trip report templates, etc.
  • Ensure quality and timely submission of site visit letters and monitoring visit reports.
  • Maintain accuracy of TD2 controlled documents related to clinical monitoring and ensure CRA compliance with TD2 controlled documents and training.
  • Develop CRA training materials and oversee the CRA training program.
  • Effectively communicate with senior management on strategies to grow the CRA business at TD2, including forecasting and predicting future department needs regarding resources, technology, and training.
  • Collaborate with Sponsors, Vendors, and TD2 departments (e.g., Project Management, Data Management, Biostatistics and Programming, Medical Monitoring, Finance, and Business Development) to successful complete clinical trial responsibilities.
  • Participate in client and bid defense meetings as requested.
  • Perform other related duties as assigned.
• Perform CRA duties as needed: 
  • Monitor assigned clinical trials in compliance with the protocol, GCP, FDA regulations, ICH guidelines, and overall clinical objectives.
  • Ensure that the safety and rights of trial patients are verified, patient enrollment eligibility is confirmed, and informed consent form (ICF) is properly obtained and documented prior to subject participation in the trial.
  • Manage trial parameters, including site feasibility, site qualification, site initiation and clinical trial start-up activities, clinical supplies management, trial enrollment, data collection, and site close-out.
  • Prepare trial documents, including SIV meeting materials, Clinical Monitoring Plan, site visit Confirmation and Follow-up letters as required by TD2 SOPs and Clinical Working Guidelines (CWGs)
  • Oversee the progress of the clinical trial by meeting routinely with the clinical trial principal investigator (PI) and other relevant site staff, maintaining appropriate telephone/written contact and conducting regular interim monitoring visits (IMV).
  • Review and monitor study data on source documentation and case report forms (CRFs) to ensure compliance with study protocols, GCP, and SOPs. Ensure data discrepancies are identified and resolved. Ensure monitoring and/or trial findings are resolved by the site accurately, completely, timely, and are properly documented and verifiable.
  • Ensure the site maintains appropriate essential documentation in the site regulatory binder as per Sponsor requirements and ICH-GCP guidelines.
  • Immediately report any fraud, misconduct, or serious breaches in the trial to the PM who will subsequently report this to the trial Sponsor.
  • Perform accountability of the clinical trial investigational product and immediately report any discrepancies to the PI, PM, and trial Sponsor.
  • Maintain appropriate CRA training requirements as per the TD2 Training Matrix to include:
    • Good Clinical Practice (GCP)
    • Health Privacy (HIPAA)
    • Human Subjects in Research
    • Project specific training conducted by the PM
    • Applicable TD2 SOPs and CWGs

Job Requirements:

• This position requires at least seven (7) years of clinical research experience, of which at least two (2) years must be in the field of oncology. Bachelor’s degree required, RN/BSN or Master’s degree in a life science discipline preferred. Additional CRA experience can be substituted for education. Minimum of three (3) years of prior work experience in a CRA role is required. Previous experience directly supervising staff in a healthcare setting is required.

Required Specialized/Technical Skills:

• Broad knowledge of GCP, ICH, and FDA regulatory requirements governing human clinical trials.
• Proven ability to exercise independent judgment and use critical thinking to analyze problems which may require multiple factors and approaches.
• Excellent technical writing skills.
• Proven experience working in cross-functional project teams.
• Excellent verbal and written communication with strong interpersonal skills.
• Experience with Microsoft Office tools and applicable business software.
• Expected 25-50% overnight travel dependent on need for accompanied field visits, CRA training, and clinical trial workload.

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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