Full Time | Ambulatory Healthcare Services2 Days Ago
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Green Key Resources is Hiring a Research Site Manager Near Miami, FL
SummaryThe Research Site Manager is responsible for directly overseeing day-to-day clinical operations including organization and implementation of all aspects of daily clinical research functions. Daily functions include but are not limited to, ensuring optimal project/trial conduct of early and later phase studies, maintaining protocol compliance, meeting clinical data quality standards, optimizing operational flow and continuous monitoring/oversight of clinical trial operations. The Research Site Manager will provide formal management and supervision of all research personnel, oversee goal performance and physical space management high-quality relationship management for staff, subjects, sponsors and CROs and all internal team professionals. Duties
The Research Site Manager will directly oversee the Inpatient Site Lead Clinical Research Coordinators, Research Assistants, and Data Entry Staff. Collaborate with the Clinical Rater Supervisor, Nursing Manager, Principal Investigators, Lead Sub-Investigator, Admissions and Unit Supervisor, and Controller to ensure cohesiveness, quality, and success of the project/trials.
Expectation of weekly meetings with President and Medical Director to provide a report/update on Nurse Manager, Pharmacy Lead, Unit Manager, Lead Sub-I, Site Lead, Unit Supervisor, Recruitment and Retention teams, Compliance, and New Business.
Ensure CTMS and data entry compliance for the site.
Mentor and support direct reports in their responsibilities and functions.
Assess staffing needs at assigned site according to projections and productivity expectations and communicate needs to Clinical Rater Supervisor, Nursing Manager, Principal Investigators, Lead Sub- Investigator, Admissions and Unit Supervisor, Controller and Human Resources.
Maintain appropriate staffing levels by flexing existing staff and hiring new staff through either traditional methods or staffing agencies, as required to meet project/trial coverage needs.
Review applicants resume and conduct initial interviews for all open direct report staff positions, provide recommendations for hire, and document outcomes with Clinical Operations and Human Resources.
Work with Human Resources, IT Manager, Training and Development team, and Admissions and Unit Supervisor to orient new employees using the new hire checklist process and complete building orientation.
Requirements
Minimum 5 years of relevant Clinical Research experience
Early phase clinical research coordinating/experience, a must.
3 years of work on psychiatric protocols, or equivalent research experience
Requires thorough knowledge of the drug development process; clinical trial management; clinical monitoring and FDA regulations and ICH Guidelines
5 years of management or team leadership experience
Proficiency in English required.
Proficiency in English and Spanish is preferred.
Familiarity with Microsoft Office, including Outlook and Excel.