Classified Title: Research Program Manager Role/Level/Range: ACRP/4/MD Salary: Commensurate with Experienced Status: Full-Time
Department: Oncology Work Schedule/Hours: Monday-Friday/8:30-5p/37.5 hours Location: East Baltimore Personnel area: School of Medicine
The Department of Oncology is seeking a Full Time Research Program Manager that will be responsible for the overall management of the clinical trials portfolio and clinical research activities within the GI Program. The candidate will be responsible for managing research staff, developing and implementing effective data management and regulatory procedures, and ensuring research staff are properly trained. Candidate will report to the Research Nurse Manager.
DUTIES AND RESPONSIBILITIES
Responsible for the recruitment, training and supervision of research data management and regulatory personnel within the Program.
Oversee the protocol approval process and maintain regulatory compliance within the Program.
Work with research coordinators, inpatient/outpatient nurses, research nurses, research pharmacy, and other research cores to optimize the practical implementation of the Program.
Ensure research staff maintain complete and accurate research data and implementing electronic charts in a real time basis and are well prepared for auditing and monitoring visits.
Work closely with Research Nurse Manager to ensure that Research Nurses and Data Management staff work together effectively.
Conduct site initiation visits for studies where the PI is the Coordinating Center. Maintain communication with affiliate institutions to ensure high quality data submission, timely submission of data and adherence to guidelines.
Initiate and conduct meetings and other research activities with sponsors of clinical trials as needed.
Manage the process of budget generation and financial management of the program in collaboration with the Research Nurse Manager, Budget specialist/Analyst and the Administrative Manager. Work closely with PI and the Institution's Office of Research Billing to ensure Insurance Coverage Analyses are completed and accurate. Participate in Prospective Reimbursement Analysis approvals with PI guidance as necessary. .
Maintain a system for tracking and reporting milestones for financial invoicing within the Program.
Actively participate in Research Program Management meetings.
Actively participate in implementing the Clinical Research Management System (CRMS) within the Program.
Analyze data associated with clinical trials, as needed by the Program.
Assist regulatory specialists with informed consents and protocol amendments for investigator-initiated studies, as needed.
Ensure SKCCC Standard Operating Procedures are in practice.
Work closely with other Program Managers and other Departments to help create effective, efficient research systems, and avoid duplication of effort.
Supervise space allocation within the designated work area.
BA/BS degree in Biological/Social Sciences or other appropriate discipline and a minimum of five years experience in complex and detailed clinical trials/medical research.required. Minimum of two years clinical experience in clinical trail and or clinical research in a patient setting required. Must have a demonstrated supervisory responsibilities, must be proficient in the use of software applications, databases, spreadsheets and work processing. Additional education may substitute for required experience, to the extent permitted by the JHU equivalency formula.
JHU Equivalency Formula: 18 graduate degree credits may substitute for one year of experience.
Master's Degree in a related field and certification as a Clinical Research Professional is desired.
The successful candidate(s) for this position will be subject to a pre-employment background check.
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