Manager, Research Operations

Tennessee Oncology, one of the nation’s largest, community-based cancer care specialists, is home to one of the leading clinical trial networks in the country. Established 1976 in Nashville, Tennessee Oncology’s mission remains unchanged: To provide access to high-quality cancer care and the expertise of clinical research for all patients, at convenient locations within their community and close to their home. Our growing network of physicians and locations is based on this mission. Tennessee Oncology is committed to advancing both the science of detection and targeted treatments, and to making these advances available to every patient. We believe caring for cancer patients is a privilege.Why Join Us? We are looking for talented and highly-motivated individuals who demonstrate a natural desire to support the meaningful work of community oncologists and the patients we serve.Job Description:The Research Operations Manager ensures the integrity and quality of clinical trials are maintained and conducted in accordance with international, federal, state, and local regulations, and Institutional Review Board (IRB) approvals. This position is primarily responsible for the accurate completion of visit procedures and collection of information from study patients according to protocols, and for protecting the health, safety, and welfare of research participants. Work is performed under the general direction of the Senior Director of Research Operations and principal investigators.ESSENTIAL FUNCTIONS:Supervise research coordinators, across multiple sites, by managing their workload and optimizing performance while ensuring regulatory complianceCollaborate with others to design and rollout new or improved workflows and standard operating procedures.Manage site qualification and site initiation visits with sponsors for clinical trial implementationReviews protocol leads for feasibility specific to resources required to carry out protocol e.g. patient population, staff, equipment, etc.Assure that protocols and associated budgets are loaded into CTMS platform in a timely mannerReviews new protocols and associated consent forms with direct reports to ensure in-depth understanding method of action, schedule of events, adverse events etc.Supervises direct reports in the screening of potential subjects for clinical trials through a careful review of the patient’s past medical history and a review of current findings against protocol-specific inclusion and exclusion criteriaOversees, across multiple sites, compliance of all research patient visits including testing and procedures per sponsor protocolOversees the maintenance of medication inventory and reconciliationAssures direct reports complete accurate and timely data collection, documentation, entry, and reporting in both sponsor and Tennessee Oncology databases and that this complies with sponsor protocol requirements, regulations, and department policies across multiple sitesLiaise with sponsor monitors regarding protocol questions and/or clarificationsCommunicates with patient, principal investigator, outside physicians, regulatory staff, and sponsor regarding serious adverse events including proper documentation and follow-upReviews protocol, amendments, notices, suspensions and terminations with direct reportsLiaises with sponsor staff such as study monitors and assists direct reports in the preparation for and completion of monitor visitsPrepares for and attends sponsor and FDA auditsAct as a resource for direct reports regarding clinical trial protocols, particularly the proper administration and expected side effects of the investigational productSupervises the procurement, processing, and shipping of biospecimens per sponsor protocol and regulationsServes as a liaison to multiple Tennessee Oncology departments, providers, and other team members regarding research protocols and regulatory compliance with particular attention to quality and optimizing workflowsProtects the rights, safety and welfare of patientsDepartmental supply monitoring and orderingConduct trial feasibility and patient screening for enrollment as necessaryTravel to all research site offices as necessaryMaintains a professional approach respecting the dignity and confidentiality of patientsMaintains a good attendance record and reports to work on timeMaintains a professional attitude and appearanceMaintain NYS licensure as applicablePerforms other duties as assignedKNOWLEDGE, SKILLS & ABILITIES:Excellent verbal and written communication skillsExcellent organization and follow-up skillsAbility to handle multiple priorities in a fast-paced environmentAbility to understand complex clinical trials protocolsAbility to oversee and guide multi-functional teamsMicrosoft Office product knowledge (Word, Excel, PowerPoint, etc.)EDUCATION & EXPERIENCE:Bachelor’s degree in biology, life sciences or nursing preferred5+ years’ work experience in pharmaceutical, clinical office or research space.Previous supervisory experience preferredSummaryLocation: TNO - GHCR Admin | Nashville, TNType: Full time