Our Clinical Operations team is looking for an outstanding team member who will drive Flatiron’s efforts to support our customers, both oncology clinical care providers (i.e. clinical trial sites) and life sciences companies (i.e. sponsors), in conducting cancer clinical trials. Successful candidates will be adept in the application of clinical trial protocols, skilled in the operational conduct of clinical trials, and excited to create and generate new knowledge meaningful to cancer patients.

This opportunity is endless, but for starters you will support both Flatiron and our life sciences partners by providing risk-based and central monitoring expertise in accordance with Good Clinical Practice (GCP) as well as Flatiron Health and/or sponsor written processes. You will collaborate with on-site monitors to assure study data flow and quality meets the highest regulatory standards, triggering on-site visit frequency and helping to direct attention to high value risk targets, while also working closely with clinical trial sites to ensure that they are set up for success in recruitment, study conduct and documentation. Working in a fast-paced and rapidly expanding business, you will be consistently challenged to partner with Flatiron Health colleagues to create a rock-solid, scalable clinical trials foundation for explosive growth.

We are looking for monitoring professionals at various levels as follows:

• Lead: Applicants with direct experience with completion of day to day monitoring activities. Looking for at least 4 years of direct experience.
• Manager: Applicants with direct experience with monitoring and clinical operations. Looking for at least 6 years of direct experience.

Roles and Responsibilities

• Central/remote monitoring review including:
• Assessment of protocol, patient safety and regulatory compliance
• Communication with clinical trial site as well as on-site monitor about study status and issue/query resolution
• Data cleaning including query generation, response review and closure
• Assessment of Key Risk Indicators, their meaning and how to mitigate issues
• Track and report trial execution performance indicators related to data flow and timeliness, site data quality and compliance to GCP.
• Identify clinical trial site specific operational problems; resolve issues and escalate as appropriate
• Communicate with with on-site monitoring team to trigger on-site monitoring frequency and communicate areas of for review during on-site visits [when appropriate]
• Prepare study monitoring reports and follow-up documentation within required timeframes.
• Manage data collection and clean-up at clinical trial sites and of study database as required; resolve technical and content issues as needed to achieve database lock targets
• Facilitate preparation and collection of site level documents; resolve problems as required
• Plan and execute site initiation and training as needed
• Assist in execution of site-level initiation and patient recruitment plans. Develop and execute contingency plans, as needed. Ensure that study milestones are met as planned
• Contribute to the preparation of trial level documents as applicable. For example, Monitoring Plan and tools, input into data capture forms/CRFs and completion guidelines, etc.
• Implement site closeout activities in conjunction with on-site monitor as required per Monitoring plan
• Participate in cross functional teams to evaluate and implement corrective and preventive actions as well as lessons-learned and process improvement

About You

• A bachelor’s or higher degree in a scientific or health care discipline required, clinical training in oncology care desired.
• At least 4 years experience in clinical trial monitoring preferably in Oncology (e.g. at a Contract Research Organization (CRO) or pharmaceutical company)
• Understand and apply clinical and business knowledge to clinical trial execution - specifically in the treatment and study of Oncologic diseases.
• Solid understanding of clinical trial design, trial execution and operations
• Knowledge and experience in clinical trial regulations (FDA) and guidelines (ICH-GCP)
• Great communication skills
• Ability to manage multiple priorities
• Computer literacy
• Proven project and site management skills
• Intellectually curious and an ability to think outside the box to apply new concepts to old problems
• Excited to work side-by-side with colleagues across functions, including those with technical and medical backgrounds
• Nose for value; able to effectively prioritize in a challenging, time-sensitive environment
• Passionate about our mission to improve healthcare through technology

Bonus Points

• Experience as a Clinical Research Coordinator, Data manager or GCP Auditor.
• Experience working at a CRO
• Experience with:
  • Risk-Based Monitoring
  • Electronic Health Records (EHR) to Electronic Data Capture (EDC)
  • Pragmatic trials
  • Real-World Evidence
  • Standard Operating Procedure (SOP) and Process development