Manager, Clinical Research Nursing

University of Miami•Miami, FL

64d•Onsite

About The Position

The University of Miami/UHealth Department of SCCC - CRS has an exciting opportunity for a Full Time Manager, Clinical Research Nursing to work at the UHealth campus in Miami, Fl. CORE JOB SUMMARY The Manager, Clinical Research Nursing manages day-to-day clinical research operations and study coordination duties, from protocol development and initiation to study close-out. The Manager, Clinical Research Nursing provides leadership and training/mentorship in planning, implementing, monitoring, coordinating, and evaluating clinical research studies. The incumbent assesses, plans, implements, and evaluates study participants’ clinical care in clinical research studies as well as clinical research policies/ procedures that protect participants in clinical research studies.

Requirements

Bachelor’s degree in nursing (BSN) from an accredited School of Nursing.
Minimum 5 years of relevant experience required
Valid State of Florida RN license required
Basic Life Support Certification (BLS)
Knowledge of business and management principles.
Ability to direct, manage, implement, and evaluate department operations.
Ability to establish department goals, and objectives that support the strategic plan.
Ability to effectively plan, delegate and/or supervise the work of others.
Ability to lead, motivate, develop, and train others.
Operational Management: Optimizes day-to-day operations and processes for efficiency and effectiveness.
Organizational Development: Ability to implement strategies to improve organizational effectiveness, engagement, and manage change.
Financial Oversight: Knowledge of financial operations and management.
Team Leadership: Ability to create and maintain a cohesive and productive team environment, build positive working relationships and work collaboratively with others.
Technical Proficiency: Skilled in using office software, technology, and relevant computer applications.
Communication: Strong verbal and written communication skills to convey ideas clearly and persuasively.

Responsibilities

Develops, implements, and evaluates study-specific protocols, SOPs, and templates that can be adopted/adapted for future studies; defines study procedures, tests, and data collection/recording; and manages day-to-day operations of multiple complex clinical research studies.
Determines, assures, and develops strategies to assure appropriate clinical involvement in clinical research studies, crossing clinical discipline boundaries as research consultant, clinical specialty-specific clinical research expert, and/or liaison among study personnel, clinical staff, and service departments.
Conducts/oversees research teams’ clinical assessments, follows-up on findings, reviews medical records/lab tests for potential/enrolled study participants.
Identifies and assures full adherence to relevant mandatory competency standards (e.g., environmental, safety, diversity) throughout study planning, implementation, and follow-up.
Develops and assures accuracy, organization, and integrity of clinical research documentation and protocol workflows. Identifies clinical safety implications during study development.
Supervises other clinicians’ administration of study drugs/device/materials according to practice standards and clinical credentials. Ensures licensed and trained personnel administer study products according to protocol, safety standards, and credentialing mandates.
Plans, implements, and evaluates strategies to effectively monitor, document, report, and follow-up on protocol deviations, unanticipated occurrences, adverse effects and evaluates and manages preventive/corrective actions.
Oversees administrative duties related to study personnel including orientation, assuring core competencies, certification mandates, safety/responsible conduct of research education; conducts performance reviews.
Assumes leadership in clinical meetings, Grand-Rounds, conferences, and seminars as clinical research study liaison.
Leads efficient clinical research nursing team meetings; assures effective communications; provides leadership in problem solving logistical challenges to assure study objectives are achieved according to protocol and projected timeline. Assures seamless collaboration with clinical services and departments in protocol planning, implementation, evaluation.
Collaborates synchronization of study visits, procedures, and clinical tests with data collection schedules, established time-points; effectively advances study participants through protocol; expedites overall study progression with minimal clinical disruption.
Assesses, documents, promotes, and problem solves study participants’, research team members’, and clinical personnel’s adherence to clinical research procedures, protocol, and timeline.
Leads effort to effectively adapt clinical plan to meet study requirements with least clinical disruption/drawback. Develops, implements, and evaluates effectiveness of SOP/decision trees to guide evaluation of clinical test results relative to the study, determines need for follow-up, assures appropriate follow-up on abnormal parameters.
Builds research competency of team and clinical collaborators; promotes career development. Develops, presents, and evaluates practice-focused training modules and CEUs.
Adheres to University and unit-level policies and procedures and safeguards University assets.