Sr. Clinical Research Program Manager

We are seeking a Sr Clinical Research Program Managerwho will be responsible for the overall management of the clinical trials portfolio and Clinical Research activities within the Hematologic Malignancies Program, both on the East Baltimore and Sibley 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/Co-Directors of Clinical Research Operations for the Division of Hematologic Malignancies and the Director of Clinical Research Administration.

Specific Duties &  Responsibilities

• Responsible for the recruitment, education, training and supervision of 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 of Hematologic Malignancies
• Directs a weekly meeting with Research Program Management to discuss the current and upcoming clinical trials portfolio, active research issues and staffing needs
• Meets regularly with Director/Co-Directors to discuss availability of resources and prioritization of protocols
• Supervises space allocation within the designated work area
• Facilitates collaboration between Hospital and University personnel including data management, inpatient, outpatient, research nursing, house staff and faculty
• Assists PI with clinical protocol development, including reviewing and assessing new protocols for clarity, thoroughness, logistical feasibility, maintaining subject safety etc.
• Assists regulatory specialists with informed consents and protocol amendments for investigator-initiated studies, as needed
• Assists PI with implementation and maintenance of research clinical protocol
• Oversees the protocol approval process
• Maintains regulatory compliance, including oversight of IND and other regulatory work within the program
• Works 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
• Ensures the proper scheduling and initiation of required research activities with sponsors of clinical trials as needed
• Ensures research staff maintain complete and accurate research data, charts in a real time basis and are well prepared for auditing and monitoring visits
• Ensures SKCCC Standard Operating Procedures are in practice
• Conducts 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
• Works with the Financial Manager to manage the process of budget generation for clinical trials in the program
• Participates in Prospective Reimbursement Analysis meetings as needed
• Works closely with the Financial Manager to maintain a system for tracking and reporting milestones for financial invoicing within the program
• Works closely with Director/Co-Directors to anticipate the impact on resources & availability of resources for clinical trials within the division
• Analyzes resource utilization by individual trials and within programs to ensure research needs are anticipated and met
• Works closely with other Clinical Research Program Managers and other departments to help create effective, efficient research systems, and avoid duplication of effort

• Bachelor's Degree in health-related sciences or related discipline.
  

• Eight years' experience in Clinical Research.
  

• Additional education may substitute for experience to the extent permitted by the JHU equivalency formula.

• Master's degree preferred.

Classified Title: Sr. Clinical Research Program Manager   
Role/Level/Range: ACRP/04/ME  
Starting Salary Range: $62,780-$86,390-$110,010 Annually (Commensurate with experience) 
Employee group: Full Time 
Schedule: M-F 8am-4:30pm 
Exempt Status: Exempt 
Location: Hybrid/School of Medicine Campus 
Department name: SOM Onc Clinical Trials  
Personnel area: School of Medicine 

Total Rewards
The referenced salary range is based on Johns Hopkins University's good faith belief at the time of posting. Actual compensation may vary based on factors such as geographic location, work experience, market conditions, education/training and skill level. Johns Hopkins offers a total rewards package that supports our employees' health, life, career and retirement. More information can be found here: https://hr.jhu.edu/benefits-worklife/

Please refer to the job description above to see which forms of equivalency are permitted for this position. If permitted, equivalencies will follow these guidelines:
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.
**Applicants who do not meet the posted requirements but are completing their final academic semester/quarter will be considered eligible for employment and may be asked to provide additional information confirming their academic completion date.

The successful candidate(s) for this position will be subject to a pre-employment background check. Johns Hopkins is committed to hiring individuals with a justice-involved background, consistent with applicable policies and current practice. A prior criminal history does not automatically preclude candidates from employment at Johns Hopkins University. In accordance with applicable law, the university will review, on an individual basis, the date of a candidate's conviction, the nature of the conviction and how the conviction relates to an essential job-related qualification or function.

The Johns Hopkins University values diversity, equity and inclusion and advances these through our key strategic framework, the JHU Roadmap on Diversity and Inclusion.

Equal Opportunity Employer

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

EEO is the Law
Learn more:
https://www.eeoc.gov/sites/default/files/migrated_files/employers/poster_screen_reader_optimized.pdf

Accommodation Information

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 Talent Acquisition Office at jhurecruitment@jhu.edu. For TTY users, call via Maryland Relay or dial 711. For more information about workplace accommodations or accessibility at Johns Hopkins University, please visit accessibility.jhu.edu.

Johns Hopkins has mandated COVID-19 and influenza vaccines, as applicable. Exceptions to the COVID and flu vaccine requirements may be provided to individuals for religious beliefs or medical reasons. Requests for an exception must be submitted to the JHU vaccination registry. For additional information, applicants for SOM positions should visit https://www.hopkinsmedicine.org/coronavirus/covid-19-vaccine/ and all other JHU applicants should visit https://covidinfo.jhu.edu/health-safety/covid-vaccination-information/.

The following additional provisions may apply, depending on campus. Your recruiter will advise accordingly.

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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