School of Medicine, Pediatric Hematology is seeking a Sr. Research Program Supervisor. Under the direct supervision of the Principal Investigator, the Sr. Research Program Supervisor is responsible for monitoring and collecting research data in the Division of Pediatric Hematology. The Sr. Research Program Supervisor is accountable for the organization, entry, maintenance and accuracy of all clinical research data for complex and detailed clinical trials, and may assist with orientation of less senior research staff in protocol and clinical research information. The Sr. Research Program Supervisor will be a for the coordination and implementation of assigned research projects within the research program and will anticipate research requirements for designated patient populations. The Sr. Research Program Supervisor will also oversee and perform data analysis for departmental studies, grants, QI projects, and manuscripts. The Sr. Research Program Supervisor may collaborate in development and writing of protocols and consent forms, in development and preparation of regulatory documents as appropriate and clarifying concerns and questions about new protocols with PI and Sponsor. This is an intermediate level position in managing research trials and registry databases within the research program. The Sr. Research Program Supervisor will also assist the PI with development of manuscripts, including analysis and preparations of tables and figures for presentations and publications. Will have responsibility for hiring and coaching research staff.

Specific Duties & Responsibilities

• Oversee and conduct recruitment, screening and enrolling of eligible patients into clinical protocols.
  
• Explain the protocol in detail and conduct informed consent procedures with potential research participants.
• Maintain good working knowledge of all assigned protocols and reporting requirements. Work on complex clinical and research studies which require a high level of knowledge, coordination, and data abstraction.
• Maintain regulatory binders for assigned protocols. Prepare and submit annual renewal requests, amendments and adverse event reports with clinical input according to IRB and Sponsor requirements. Adhere to all protocol requirements to ensure the validity of the clinical research data.
• Assist the principal investigator and grant/program manager in defining information and plans required to accomplish goals of studies. Design and create protocol specific case report forms as needed. Assist less experienced staff in design and creation of such forms.
• Verify patient eligibility for studies by comparing patient history and clinical laboratory results with protocol requirements.
• Collect, enter and compile clinical data from a variety of sources. Ensure accuracy and timeliness of data so that information may be used by the physicians in treatment planning for individual patients, and by the Principal Investigator in grant writings, presentations and publication.
• Design and compile materials which aid physicians/other staff in complying with protocol requirements.
• Meet regularly with Principal Investigator to review data accuracy and overall study progress. Participate in all mandatory meetings to develop increasing knowledge of assigned research and clinical trials.
• Use advanced knowledge of GraphPad Prism and other data analysis software to perform and oversee data analysis for departmental studies, grants, QI projects, and manuscripts.
• Develop and maintain a protocol database or spreadsheet for tracking patient activity, data collection, and financial management. Participate in data analysis as needed.
• Meet with department financial management staff to identify procedures, laboratory tests and protocol events that require invoicing to the Sponsor as defined in the financial contract. Participate in the development of invoicing schedules.
• Complete minimum requirement for continuing educational units. Is knowledgeable of and complies with Good Clinical Practices, ICH Guidelines and Departmental Research Office policies. May instruct introductory level research personnel in these guidelines and policies.
• Prepares contract application and internal budgets for contracts administration.
• Acts as a liaison between pharmaceutical companies and the Department of Contracts Administration within the University.
• Conducts contract reviews to ensure they are executed properly in terms of budget analysis.
• Serves as central resource for clinical trials group, including the development of guidelines/templates for protocol development to ensure that all NIH, GCP, OHRP, JHU, and Federal regulations are followed in both the development and implementation of clinical trials.
• Creating consent forms, preparing IRB regulatory submissions, initiating and supervising study regulatory files for all trials in the pediatric hematology division.
• Prepares and submits advertisement and recruitment plan including radio, newspaper, flyers, local health events, and local associations pertaining to disease category and internal publications and/or web sites.
• Functions as a liaison with the IRB and Clinical Research Office. Tracks each protocol through the IRB/subcommittee approval process, evaluates for recurrent problems, develops and implements systems to decrease delays in the trial approval, and intervenes as required to facilitate approval process.
• Works with the research pharmacy with coordinating the dispensing of investigational drugs (if required).
• Works with research pharmacy to coordinate study drug delivery and payment.
• Ensures smooth implementation of new trials from initial contact through study activation.
• Performs laboratory processing.
• Participates in site development and start up meetings with sponsoring agencies as required.
• Attends sponsor-initiated investigator meetings as new studies begin.
• Oversees submission of amendments and yearly protocol renewals. Plans and prepares for regular monitoring visits.
• On occasion will prepare for and attend internal, sponsor, FDA, OSHA, OHRP or JCAHO inspections/audits. Preparation for these audits is very important.
• Provides cost-benefit analysis of budgetary considerations and resource utilization issues.
• Prepare invoices to sponsor accurately and in a timely manner.
• Submit invoices to sponsors and work with divisional finance staff to reconcile accounts regularly ensuring no deficits in clinical trials accounts.
• Collaborates with JHU based staff, investigators, regulatory bodies, and sponsoring organizations to resolve study-related needs.
• Participates on conference calls with sponsor regarding status of clinical trials and site selection meetings.
• Assists PI with protocol development, which may include writing informed consents. Initiate and/or maintain activities, systems and processes to increase.
• Referrals and increase accruals to multiple clinical trials. Trains and provides oversight of research data management and regulatory issues within the research program.
• Development of Standard of Procedures (SOP)
• Supervision of current research staff (problem solving, etc)
• Training of new research staff.
• Bridge between research staff and others (PI, HR, clinical, etc)
• Support for IRB for investigator-initiated studies.
• Oversight of sponsored trial eligibility.
• Oversight of volunteer operations (assess need, assign volunteers)
• Oversight of patient tracking.
• Perform all other duties as assigned.

Supervisory Responsibility

• Oversee a team of 2 at Johns Hopkins East Baltimore Campus

Special Knowledge, Skills, & Abilities

• Proficiency in the use of common software applications (GraphPad Prism, etc.), databases (REDCap, etc.), regulatory applications (eIRB, etc.), clinical computer systems (Epic, etc.) spreadsheets, and word processing required.
• Excellent organizational skills required.
• Excellent attention to detail skills required.
• Must have ability to manage multiple and competing priorities.
• Must have excellent time management skills.
• Must have excellent oral and written communication skills.
• Must be able to work independently.
• The successful applicant will demonstrate an ability to work well with other professionals with minimal supervision and be comfortable being part of a diverse professional team.

• Bachelor's Degree in related discipline.
• Three years related experience, with some supervisory experience strongly preferred.
• Additional education may substitute for required experience, to the extent permitted by the JHU equivalency formula.

• Some supervisory experience strongly preferred.
• Experience with working and interacting with patients of at least one year.
• Masters in relevant field.

Classified Title: Sr. Research Program Supervisor  
Role/Level/Range: ACRP/03/MC  
Starting Salary Range: Min $47,500 - Max $83,300 Annually ($60,000 budgeted; Commensurate with experience) 
Employee group: Full Time 
Schedule: M-F; 8:30 - 5:00 
Exempt Status: Exempt 
Location: Hybrid/School of Medicine Campus 
Department name: ​​​​​​​SOM Ped Hematology 
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. The COVID-19 vaccine does not apply to positions located in the State of Florida. 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.

Note: Job Postings are updated daily and remain online until filled.

About Johns Hopkins University

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 Bal...timore. The Paul H. Nitze School of Advanced International Studies is located in Washington's Dupont Circle area.

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