Apply for this Position Responsibilities & Qualifications: Clinical Research Administrator - Clinical Research Management Office The Clinical Research Management Officer ( CRMO ) is a shared institutional resource of the Lombardi Comprehensive Cancer Center at Georgetown that provides administrative, nursing, and data management support for cancer treatment clinical trials conducted by Lombardi Investigators. This includes all regulatory documents, IRB submissions, budget and contract negotiations, consenting of subjects, case management of patients while on study, side effect management, completion of case report forms, meeting with monitors, maintaining trial information on the Lombardi website, and design of electronic case report forms for institutional trials. Th e Clinical Research Administrator provides overall direction for the initiation, monitoring, completion and reporting of clinical studies in cancer research in the Cancer Center. S/he is at the heart of managing complex, highly-regulated protocols that require coordination with multiple parties inside and outside Georgetown University - and offer patients hope for more innovative and successful treatments than would otherwise be available. Duties include but are not limited to: Staff Management Provides supervision of research personnel and support staff. For Research personnel and support staff, recruits, assigns projects, supervises, conducts performance appraisals, and disciplines as necessary. Provides adequate workspace and materials, evaluates workload, and adjusts staff levels to meet projected workload. Conducts regular staff meetings, ensures orientation and trainings are completed, and maintains documentation of training and certification. Clinical Research Administration Develops and coordinates departmental policies and procedures to ensure the efficient operation of clinical trials – including coordination of systems and financial planning. Ensures all aspects of grants and clinical trial management - including IRB submissions, participant consenting, recruitment strategies, and study documentation - are conducted under Good Clinical Practice (GCP) and in accordance with University and hospital policies and procedures. Ensures adherence to grant sponsor, IRB and university accounting and grant administration guidelines. Designs patient recruitment strategies and monitors enrollment goals and implement recruitment strategy. Collects and validates accrual data for all CCSG related accruals, adhering to Data Table 3 and 4 requirements from the NIC, and maintains master list of all studies and subject participation at sites. Oversees and ensures the implementation of the Principal Investigator's recommendation for adverse event interventions, and ensures that any serious adverse events are reported to sponsor and IRB and properly documented. Liaison and Representation Supports and participates in the Clinical Research Committee (CRC), Scientific Progress Review Committee (SPRC) and Resource Allocation Committee for Investigator Initiated Clinical Trials (RACIIT). Acts as liaison between the research staff, sponsors, IRB and regulatory agencies, government, and university officials. Maintains and disseminates accurate communication of policies, finances, and regulatory issues. Serves as key resource to research participants and collaborators and participates in planning activities to determine current and future needs. Requirements Bachelor’s degree. At least ten years in clinical research - preferably oncology research – that includes supervisory responsibility for professional staff. Possess Associate of Clinical Research Professionals (ACRP) Certification - ACRP Certification Programs Possess HIPAA certification – or become certified within 30 days of hire. Excellent skills in interpersonal communication and organizational skills, as well as the ability to problem-solve and multi-task. EEO Statement Georgetown University is an Equal Opportunity, Affirmative Action employer fully dedicated to achieving a diverse faculty and staff. All qualified candidates are encouraged to apply and will receive consideration for employment without regard to race, sex, sexual orientation, age, religion, national origin, marital status, protected veteran status, disability or other categories protected by law. Apply for this Position New Search
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