Manager, Clinical Research Nursing

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The Department of Clinical Translational Research Site is currently seeking a full time Manager, Clinical Research Nursing to work in Miami. 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.

CORE RESPONSIBILITIES:

1.    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.
2.    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.
3.    Conducts/oversees research teams’ clinical assessments, follows-up on findings, reviews medical records/lab tests for potential/enrolled study participants.
4.    Identifies and assures full adherence to relevant mandatory competency standards (e.g., environmental, safety, diversity) throughout study planning, implementation, and follow-up. 
5.    Develops and assures accuracy, organization, and integrity of clinical research documentation and protocol workflows. Identifies clinical safety implications during study development. 
6.    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. 
7.    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. 
8.    Oversees administrative duties related to study personnel including orientation, assuring core competencies, certification mandates, safety/responsible conduct of research education; conducts performance reviews.
9.    Assumes leadership in clinical meetings, Grand-Rounds, conferences, and seminars as clinical research study liaison. 
10.    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. 
11.    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.
12.    Assesses, documents, promotes, and problem solves study participants’, research team members’, and clinical personnel’s adherence to clinical research procedures, protocol, and timeline.
13.    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. 
14.    Builds research competency of team and clinical collaborators; promotes career development. Develops, presents, and evaluates practice-focused training modules and CEUs.
15.    Adheres to University and unit-level policies and procedures and safeguards University assets.

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