This role will support the quality assurance, clinical surveillance, and post- positive provider outreach programs. This position sits in the Real World Evidence (RWE) team within Medical Affairs and reports into the Head of RWE. This role requires a hybrid skill set between clinical research, clinical data management, working with healthcare providers, and understanding the oncology space. ***Former clinical study managers, providers (RNs, NPs, PAs), and care navigation managers with a data collection background are encouraged to apply.***
Primary role responsibilities include:
Follow-up on results from products, including managing specific post-positive call out queues, tracking associated systems, and handing off calls to relevant internal team members.
Clinical data collection of patients who have received a commercial Galleri test. This includes:
Identification of cases with Medical Science Liaisons (MSL) and other staff, including ongoing cases, retrospective follow up, and backlog from field data.
Outreach to providers to collect patient outcomes and follow-up.
Entering data into internal databases and trackers.
Assisting in the clinical review of data for use in Quality Assurance/Quality Improvement (QA/QI).
Understanding of GCP and protocol relevant guidelines.
This may include follow up of Cancer Signal Detected and Cancer Signal Non Detected results.
Foster and maintain relationships with provider and healthcare institutions to obtain data after each Galleri tests, and track status of communications with providers.
Data extraction of Galleri test cases from Laboratory Information Management System (LIMS).
May support generation of outcomes metrics and analyses
Ensure that data integrity is maintained throughout the data management process.
Effectively communicate project status, critical path activity timing, resource requirements, and risks, as appropriate.
Adhere to Good Clinical Practice and exercise sound judgment in handling protected health information (PHI).
Qualifications:
Minimum 5-6 years relevant experience, or combination of experience and education, in clinical research with demonstrated foundational knowledge of clinical research and clinical data principles and concepts (e.g., clinical data acquisition, ensuring data quality, Good Clinical Practice, Good Documentation Practices).
Medical or clinical training in oncology and/or clinical research experience in oncology studies preferred (MD not required).
Experience working with clinical data and clinical data abstraction.
Demonstrated experience working with electronic data capture software systems such as: Medidata Rave, Medrio, etc.
Demonstrated experience working directly with healthcare providers and healthcare staff staff within a hospital or clinic setting.
Experience with handling and protecting sensitive health information, including PHI.
Demonstrated understanding and application of principles, practices, and regulatory standards that govern the industry.
This is a Contract Position for 1 year with the possibility of extension.
Seniority level
Mid-Senior level
Employment type
Contract
Job function
Quality Assurance
Industries
Human Resources Services
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