Lead Clinical Research Coordinator

Department CC019980 Research Admin Payroll Control Job Description Summary Position is needed as soon as possible to allow sufficient time to train new employee in all aspects of the Regulatory Lead. Position Responsibilities Assists Departmental Manager in managing the department of Regulatory to ensure that activities and programs are consistent with established objectives, administrative policies & protocol requirements. Assists Departmental Manager to Coordinate work of support personnel involved in implementation of regulatory requirements. Assists Departmental Manager in overseeing and monitoring activities of the regulatory department activities and clinical department staff; establishes and implements standard policies and procedures related to compliance & GCP. Represents the research program as needed for hospital, departmental, national or local meetings. Provides creative leadership and customized solutions to meet the needs of the research program and its affiliate institutions. Attends all pre-study and site initiation visits. Collaborates with program leadership on strategic planning; provides effective leadership in assessments, generate reports, and facilitate the resolution of problems as needed. Meets with auditors/monitors to assist in resolving any items/queries. Assists Departmental Manager to Develop and implement communication strategies and materials directed to internal and external audiences that support program goals and objectives. Represents the research program as needed for hospital departmental, national or local meetings; Serve as liaison for implementation of hospital/federal/regulatory agency policies and procedures to affiliate. Reviews and approves all regulatory packets prior to coordinators submitting to the IRB for review. Assists with preparation for NCI and FDA audits and sponsor audits. Acts as resource for research staff and physicians with regard to clinical protocols. All other tasks as assigned. Qualifications License/Registration/Certification related field certification preferred Education College and or technical degree preferred Experience 1 year Medical background required; research experience preferred Benefits Health benefits Life insurance Long-term disability coverage Healthcare spending accounts Retirement plan Paid time off Pet Insurance Tuition reimbursement Employee assistance program Wellness program On-site housing for select positions and more! Certification / Degree Requirements #J-18808-Ljbffr