Department: Oncology, Breast and Ovarian Cancer Work Schedule/Hours: Monday-Friday/8:30-5:00pm/37.5 hours
The Senior Clinical Research Program Manager will be responsible for the overall management of the clinical trials portfolio and clinical research activities within the Breast Ovarian Cancer (BOCP) 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 Director of the BOCP and the 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 data management. 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 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 Program
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 Program 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 Program Leadership to anticipate the impact on resources & availability of resources for clinical trials within the Program
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. Seven years' experience in clinical research at an academic, government, or pharmaceutical industry environment. Extensive experience with clinical research sciences, regulatory affairs. Extensive experience with protocol and informed consent writing, data analysis, grant writing, and manuscript preparation and production. Prior experience managing clinical research staff required. Additional education (graduate level) may substitute for required experience to the extent permitted by the JHU Equivalency Formula.
Special Knowledge, Skills, or Abilities / Competencies: *Excellent organizational skills required *Excellent attention to detail skills required *Knowledge of medical terminology required *Familiar with medical procedure and laboratory fees *Ability to manage multiple and competing priorities *Knowledge of clinical research practices and principles required *Ability to understand a clinical trial financial contract *Must have excellent time management skills *Must have excellent oral and written communication skills *Ability to work in a team and demonstrated interpersonal skills
JHU Equivalency Formula: 18 graduate degree credits may substitute for one year of experience.
Master's Degree. Certification as a Clinical Research Professional.
Johns Hopkins University remains committed to its founding principle, that education for all students should be grounded in exploration and discovery. Hopkins students are challenged not just to learn but also to advance learning itself. Critical thinking, problem solving, creativity, and entrepreneurship are all encouraged and nourished in this unique educational environment. After more than 130... years, Johns Hopkins remains a world leader in both teaching and research. Faculty members and their research colleagues at the university's Applied Physics Laboratory have each year since 1979 won Johns Hopkins more federal research and development funding than any other university. The university has nine academic divisions and campuses throughout the Baltimore-Washington area. The Krieger School of Arts and Sciences, the Whiting School of Engineering, the School of Education and the Carey Business School are based at the Homewood campus in northern Baltimore. The schools of Medicine, Public Health, and Nursing share a campus in east Baltimore with The Johns Hopkins Hospital. The Peabody Institute, a leading professional school of music, is located on Mount Vernon Place in downtown Baltimore. The Paul H. Nitze School of Advanced International Studies is located in Washington's Dupont Circle area.