clinical operations manager jobs

Research Registered Nurse Lead

Summary GENERAL SUMMARY: Provides strategic and operational leadership for clinical research activities, ensuring studies are conducted safely, ethically, and in compliance with regulatory, institutional and sponsor requirements. This role oversees study coordination across multiple protocols, mentors and supports research staff and serves as a primary liaison among investigators, sponsors, regulatory bodies, and clinical teams. Will be responsible for optimizing research operations, promoting high-quality data integrity, safeguarding participant safety, and advancing a culture of excellence and accountability in clinical research. Integrates nursing practice with research coordination, supporting excellence in patient-centered research care. PRINCIPAL JOB FUNCTIONS: *Commits to the mission, vision, beliefs and consistently demonstrates our core values. *Acts as a liaison with investigators, sponsors, Investigational Review Board and hospital leadership. *Performs all duties of a Research Registered Nurse. Providing direct clinical nursing care to research participants in accordance with study protocols, nursing standards and institutional policies. Monitors study performance metrics, enrollment goals and data quality. Assist with workload prioritization, staff coordination and study coverage. Identifies and implements process improvements to enhance efficiency and compliance. Supports development and implementation of standard operating procedures (SOPs) and institutional policies and procedures. Support onboarding and competency validation of research nursing staff. Promote adherence to Good Clinical Practice (GCP), nursing standards and regulatory requirements. Foster a culture of safety, quality and improvement, and continuous learning. Leads and participates in multidisciplinary research committees and operations meetings. Provides feedback to leadership on resource needs, process gaps and opportunities for improvement. Ensures compliance with clinical research billing regulations, including CMS rules, Medicare Coverage Analysis (MCA) and institutional billing policies. Collaborates with research finance, billing compliance and revenue cycle teams to ensure accurate designation of routine care vs. research-related services. Reviews study protocols, informed consent documents and clinical trial agreements to support appropriate billing determinations. Verifies correct charging, coding and documentation of research-related services in the electronic health record. Supports clinical research contract management activities in collaboration with research administration, legal and finance teams. Reviews clinical trial agreements, budgets and statements of work to ensure alignment with protocol requirements, hospital services and study operations. Identifies and communicates nursing, clinical and operational requirements that impact study feasibility, staffing and cost recovery. Supports the departmental budgetary procedure to ensure proper operational and capital planning; appropriate and efficient use of resources, and consistent compliance to budgetary and fiscal controls. Maintains professional growth and development through seminars, workshops, and professional affiliations to keep abreast of latest trends in field of expertise. Participates in meetings, committees and department projects as assigned. Performs other related projects and duties as assigned. (Essential Job functions are marked with an asterisk “*”). REQUIRED KNOWLEDGE, SKILLS AND ABILITIES: Knowledge of ICH-GCP, FDA regulations (21 CFR50, 54, 56, 312, 812), federal/state requirements governing clinical research, HIPAA, and human subject protection requirements. Knowledge of investigational review board processes, informed consent, protocol deviations and adverse event reporting. Knowledge of patient safety principles in clinical research. Knowledge applicable to inpatient and outpatient research settings. Knowledge of standard of care vs. research-related procedures. Knowledge of medication administration, specimen handling, and clinical assessments related to research protocols. Knowledge of clinical trial lifecycle management, including feasibility, start-up, conduct, close-out and audits. Knowledge of research billing compliance, coverage analysis and charge capture processes. Knowledge of clinical trial budgets, sponsor payments, invoices and financial reconciliation. Knowledge of research contracts, confidentiality agreements and sponsor obligations. Knowledge of computer hardware equipment and software applications relevant to work functions. Skill in conflict resolution and stakeholder engagement. Skill in regulatory document preparation, maintenance and audit readiness. Skill in electronic research systems e.g. (Clinical Trial Management Systems, electronic health records, electronic data collection, regulatory platforms). Skill in maintaining attention to detail while delivering accurate and timely documentation. Skill in time-management.Skill in tracking milestones, deliverables, and compliance metrics. Ability to serve as a clinical and operational resource across departments. Ability to communicate effectively both verbally and in writing with patients, families, investigators, sponsors and regulatory bodies. Ability to problem-solve and engage independent critical thinking skills. Ability to perform crucial conversations with desired outcomes. Ability to maintain confidentiality relevant to sensitive information. Ability to prioritize work demands and work with minimal supervision. Ability to manage multiple studies, deadlines and priorities simultaneously. Ability to translate protocol requirement into clinical workflows. Ability to work independently with minimal supervision while maintaining accountability. Ability to serve as the primary operational lead for assigned studies or programs. Ability to represent the research program professionally during audits, inspections and sponsor interactions. Ability to establish and maintain effective working relationships with all co-workers, clinical and non-clinical colleagues. Ability to maintain regular and punctual attendance. EDUCATION AND EXPERIENCE: Current Registered Nurse licensure from the State of Nebraska or approved compact state of residence as defined by the Nebraska Nurse Practice Act. Bachelor’s degree required. Minimum two (2) years of clinical experience required. Experience in clinical research, study coordination, data management and study development is preferred. Leadership experience preferred. OTHER CREDENTIALS / CERTIFICATIONS: Basic Life Support (BLS) certification required. Bryan Health recognizes American Heart Association (for healthcare professionals), American Red Cross (for healthcare professionals) and the Military Training Network. Advanced Cardiac Life Support preferred. Clinical Research Nurses certification required within two (2) years of eligibility in alignment with professional standards and regulatory requirements. PHYSICAL REQUIREMENTS: (Physical Requirements are based on federal criteria and assigned by Human Resources upon review of the Principal Job Functions.) (DOT) – – Characterized as medium work requiring exertion of 35 to 50 pounds of force occasionally, and/or up to 10 to 25 pounds of force frequently, and/or greater than negligible up to 10 pounds of force constantly to move objects including the human body.