Classified Title: Sr. Clinical Research Program Manager Role/Level/Range: ACRP/4/ME Salary: Commensurate with Experience 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 Sr. Clinical Research Program Manager that will be responsible for the overall management of the clinical trials portfolio and clinical research activities within the Upper Aerodigestive Cancer (UAD) Program, both on the East Baltimore and Bayview campuses. The candidate will be responsible for managing research staff, developing and implementing effective data management and regulatory procedures, providing education to research staff and ensuring research staff are properly trained. Candidate will have a dual reporting relationship to the Directors of the UAD Program and the Assistant Director of Clinical Research Administration.
DUTIES AND RESPONSIBILITIES
Responsible for the recruitment, education, training and supervision of the research data management and regulatory personnel within the Program.
Actively manages personnel within research data management:
Assesses staff workload and determines DM assignments
Works in collaboration with Research Nurse Manager to
determine individual research nursing assignments
Facilitates effective teamwork between research nursing and
Conducts performance appraisals for data managers and
contributes to the evaluation process for Research Nursing
and other staff within the research program
Responsible for recruiting data management and research nursing personnel, and in conjunction with the Research Nurse Manager, is responsible for hiring research nursing personnel.
Responsible for development and implementation of policy and procedures for clinical research within the Division
Directs a weekly meeting with Research Program Management to discuss the current and upcoming clinical trials portfolio and active research issues and staffing needs
Meets regularly with Divisional leadership to discuss availability of resources and prioritization of protocols
Supervise space allocation within the designated work area
Facilitates collaboration between Hospital and University personnel including data management, inpatient, outpatient and research nursing, house staff and faculty.
Assist PI with clinical protocol development, including reviewing and assessing new protocols for clarity, thoroughness, logistical feasibility, maintaining subject safety etc.
Assist regulatory specialists with informed consents and protocol amendments for investigator-initiated studies, as needed
Assist PI with implementation and maintenance of the research clinical protocol:
Oversee the protocol approval process
Maintain regulatory compliance, including oversight of IND/regulatory work within the Program
Work with research coordinators, inpatient/outpatient nurses, research nurses, Research Nursing Manager, research pharmacy, and other research cores to optimize the practical implementation of the Program
Ensure the proper scheduling and initiation of required research activities with sponsors of clinical trials as needed.
Ensure research staff maintain complete and accurate research data and charts in a real time basis and are well prepared for auditing and monitoring visits
Ensure SKCCC Standard Operating Procedures are in practice.
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.
Manage the process of budget generation and financial management of the program in collaboration with the Sr. 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 meetings as needed
Work closely with the Sr. Administrative Manager to maintain a system for tracking and reporting milestones for financial invoicing within the Program
Work closely with Divisional Leadership to anticipate the impact on resources & availability of resources for clinical trials within the Division.
Analyze resource utilization by individual trials and within programs to ensure research needs are anticipated and met
Work closely with other Clinical Research Program Managers and other Departments to help create effective, efficient research systems, and avoid duplication of effort. Work closely with Research Nurse Manager to ensure that Research Nurses and Data Management staff work together effectively.
Bachelor's Degree in health related sciences and seven years' experience in clinical research at an academic, government, or pharmaceutical industry environment. Candidate must have extensive experience with clinical research sciences, regulatory affairs, experience with protocol and informed consent writing, data analysis, grant writing, and manuscript preparation and production and must have prior experience managing clinical research staff. Additional education (graduate level) may substitute for required experience and additional experience may substitute for required education to the extent permitted by the JHU Equivalency Formula.
JHU Equivalency Formula: 30 undergraduate degree credits (semester hours) or 18 graduate degree credits may substitute for one year of experience. Additional related experience may substitute for required education on the same basis. For jobs where equivalency is permitted, up to two years of non-related college course work may be applied towards the total minimum education/experience required for the respective job.
Master's Degree 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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