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Tennessee Oncology · 14 hours ago

Manager, Research Operations

Nashville, TN

Full-time

Onsite

Mid, Senior Level

5+ years exp

Tennessee Oncology is one of the nation’s largest community-based cancer care specialists, committed to providing high-quality cancer care and advancing clinical research. The Research Operations Manager ensures the integrity and quality of clinical trials, overseeing research coordinators and managing compliance with regulations and protocols across multiple sites.

Clinical TrialsHealth CareHealth DiagnosticsOncology

Responsibilities

Supervise research coordinators, across multiple sites, by managing their workload and optimizing performance while ensuring regulatory compliance

Collaborate 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 implementation

Reviews 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 manner

Reviews 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 criteria

Oversees, across multiple sites, compliance of all research patient visits including testing and procedures per sponsor protocol

Oversees the maintenance of medication inventory and reconciliation

Assures 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 sites

Liaise with sponsor monitors regarding protocol questions and/or clarifications

Communicates with patient, principal investigator, outside physicians, regulatory staff, and sponsor regarding serious adverse events including proper documentation and follow-up

Reviews protocol, amendments, notices, suspensions and terminations with direct reports

Liaises with sponsor staff such as study monitors and assists direct reports in the preparation for and completion of monitor visits

Prepares for and attends sponsor and FDA audits

Act as a resource for direct reports regarding clinical trial protocols, particularly the proper administration and expected side effects of the investigational product

Supervises the procurement, processing, and shipping of biospecimens per sponsor protocol and regulations

Serves 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 workflows

Protects the rights, safety and welfare of patients

Departmental supply monitoring and ordering

Conduct trial feasibility and patient screening for enrollment as necessary

Travel to all research site offices as necessary

Maintains a professional approach respecting the dignity and confidentiality of patients

Maintains a good attendance record and reports to work on time

Maintains a professional attitude and appearance

Maintain NYS licensure as applicable

Performs other duties as assigned

Qualification

Clinical trial managementRegulatory complianceSupervisory experienceMicrosoft OfficeCommunication skillsMulti-taskingUnderstanding protocolsOrganizational skills