Senior Clinical Research Program Manager
Salary: Commensurate with Experience
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 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 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.
If you are interested in applying for employment with The Johns Hopkins University and require special assistance or accommodation during any part of the pre-employment process, please contact the HR Business Services Office at email@example.com. For TTY users, call via Maryland Relay or dial 711.
The following additional provisions may apply depending on which campus you will work. Your recruiter will advise accordingly.
During the Influenza ("the flu") season, as a condition of employment, The Johns Hopkins Institutions require all employees who provide ongoing services to patients or work in patient care or clinical care areas to have an annual influenza vaccination or possess an approved medical or religious exception. Failure to meet this requirement may result in termination of employment.
The pre-employment physical for positions in clinical areas, laboratories, working with research subjects, or involving community contact requires documentation of immune status against Rubella (German measles), Rubeola (Measles), Mumps, Varicella (chickenpox), Hepatitis B and documentation of having received the Tdap (Tetanus, diphtheria, pertussis) vaccination. This may include documentation of having two (2) MMR vaccines; two (2) Varicella vaccines; or antibody status to these diseases from laboratory testing. Blood tests for immunities to these diseases are ordinarily included in the pre-employment physical exam except for those employees who provide results of blood tests or immunization documentation from their own health care providers. Any vaccinations required for these diseases will be given at no cost in our Occupational Health office.
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