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Clinical Research Coordination Lead
4 months ago
The Clinical Research Coordination Lead will provide technical guidance and subject matter expertise to facilitate the coordination and conduct of clinical research studies and/or clinical trials within the department/division /unit within Nemours. This individual will play a key role by helping to coordinate, implement and complete clinical research studies and/or clinical trials. Provides oversight, training, education to research staff., participate in continuous improvement projects, and the development and implementation of standard operating procedures. Conducts meetings with Clinical Trials Management and Clinical Research Administration to discuss Key Performance Indicators and clinical trials budgets within the department/division/unit they are working with. In addition, the Lead Clinical Research Coordinator will supervise and develop Clinical Research team members within the department. This position will report to the Clinical Trials Manager.
* Perform routine operational activities for multiple research protocols.
* Assist with hiring, training, and oversight of research staff.
* Conducts performance appraisals for direct reports in collaboration with Principal Investigators and Clinical Trials Manager according to Nemours expectations on an annual basis.
* Develop and sustain a close working relationship with the studies' Principal Investigators (PIs), including regular meetings to discuss projects issues, recruitment, consenting, study execution, specimen processing, specimen shipment, and potential adverse events.
* Liaise between site research personnel, industry sponsors, PIs, Supervisor, and clinical departments.
* Collaborate closely with various site departments/teams, including finance, relevant Nemours administrative representatives, and the local IRB, if applicable
* Coordinate schedule of assessments from initial submission of feasibility until study closeout
* Provide awareness of research protocols to appropriate site-level personnel, including physicians, nurses, clinical staff, and administrators
* Document all specific tasks required by the protocol (i.e., medication forms, quality of life questionnaires, neuro exams, vital signs sheets, times of lab draws, etc.)
* Document all patient, staff, and sponsor correspondence, including follow-up encounters, adverse events, interventions, pharmacy dispensations, and patient phone calls.
Qualifications:
* Bachelor's degree required
* At least 3 years of Clinical Research experience
* Active SOCRA or ACRP certification required
* American Heart Association Basic Life Support
