Research Program Coordinator - 117191

Requisition ID: 117191

Research Program Coordinator

The Department of Neurology is seeking a Research Program Coordinator for the Neurofibromatosis Therapeutic Acceleration Program (NTAP). The Neurofibromatosis Therapeutic Acceleration Program (NTAP) is a philanthropically funded research organization focused on developing effective therapies for plexiform and cutaneous neurofibromas, the two most common tumors afflicting patients with Neurofibromatosis Type 1 (NF1). NTAP uses a highly collaborative approach that brings together patients, clinicians, researchers, industry, and government to determine where resources are most effectively deployed to produce meaningful treatments for plexiform and cutaneous neurofibromas. Exceptional scientific partners with innovative ideas are recruited to make these plans a reality, through both targeted programs and investigator-initiated proposals.

Under the direct supervision of the Director of Clinical research or the Principal Investigator, the Research Program Coordinator is responsible for monitoring the clinical course and collection of research data on patients entered onto research protocols and participating sites. The Research Program Coordinator is responsible 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. This is an intermediate level position in managing clinical trials and/or registry databases within the research program.

Specific Duties/Responsibilities

• Maintains good working knowledge of all assigned protocols and reporting requirements.
• Works on complex clinical studies, which require a high level of knowledge, coordination, and data abstraction.
• Transmits and distributes protocol information.
• Helps maintain IRB approval for studies
• Responsible for submission, verification, and maintenance of protocol specific information on NTAP’s database.
• Maintains regulatory binder for each assigned protocol.
• Prepares and submits annual renewal requests, amendments, and adverse event reports with clinical input according to IRB and Sponsor requirements.
• Adheres to all protocol requirements to ensure the validity of the clinical research data.
• May assist the principal investigator and/or program manager in defining information and plans required to accomplish goals of studies.
• Will design and create protocol specific case report forms as needed.
• May also assist less experienced staff in design and creation of such forms.
• Verifies patient eligibility for studies by comparing patient history and clinical laboratory results with protocol requirements.
• Confirms patient registrations and relevant data points in databases for NTAP.
• Maintains a research chart for each patient.
• Collects, enters and compiles clinical data from a variety of sources.
• Ensures accuracy and timeliness of data so that information may be used by the physician in treatment planning, presentations, and publication.
• Verifies scheduling of patient appointments, tests, and followup visits at the appropriate time in the treatment cycle to ensure completion of protocol requirements.
• May design and compile materials that aid physicians/other staff in complying with protocol requirements for these visits and tests.
• Meets regularly with Principal Investigator, Research Nurse, and Research Program Manager to review data accuracy and overall study progress.
• Participates in all mandatory meetings to develop increasing knowledge of assigned clinical trial and Registry requirements.
• Will develop and maintain a protocol database or spreadsheet for tracking patient activity, financial management and data analysis as needed.
• Will meet with clinical trial financial management staff to identify procedures, laboratory tests and protocol events that require invoicing to the Sponsor as defined in the financial contract.
• May participate in the development of invoicing schedules.
• Prepares reports on individual patients or the study as required by the principal investigators and/or external agencies.
• Enters patient demographic and clinical data into institutional database as required.
• Responds in a timely manner to special projects or queries related to the data.
• Prepares for and participates in monitoring and audits of studies.
• Corrects errors in database when necessary.
• Writes responses to audit reports with input from the Principal Investigator.
• Completes minimum requirement for continuing educational units.
• Is knowledgeable of and complies with Good Clinical Practices, ICH Guidelines and SKCCC Clinical Research Office policies.
• May instruct introductory level clinical research personnel in these guidelines and policies.
  
  
  

Additional Knowledge, Skills, And Abilities

• Working knowledge of REDCap
• Knowledge of clinical research practices and principles required.
• Ability to understand a clinical trial financial contract.
  
  
  

Minimum Qualifications

• Bachelor's degree in related discipline.
• Additional related experience may substitute for required education, tothe extent permitted by the JHU equivalency formula.
  
  
  

Preferred Qualifications

• Three (3) years of experience in complex and detailed clinical trials/medical research is strongly preferred.
  
  
  

Classified Title: Research Program Coordinator

Role/Level/Range: ACRO40/E/03/CD

Starting Salary Range: Starting Salary Range: $17.20 - $30.30 HRLY (Commensurate w/exp.)

Employee group: Full Time

Schedule: M-F 8:30 am - 5:00 pm

Exempt Status: Non-Exempt

Location: School of Medicine Campus

Department name: SOM Neuro Neurological Oncology

Personnel area: School of Medicine

Total Rewards

The referenced base salary range represents the low and high end of Johns Hopkins University’s salary range for this position. Not all candidates will be eligible for the upper end of the salary range. Exact salary will ultimately depend on multiple factors, which may include the successful candidate's geographic location, skills, work experience, market conditions, education/training and other qualifications. 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/.

Education and Experience Equivalency

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 Completing Studies

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.

Background Checks

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.

Diversity and Inclusion

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

https://www.eeoc.gov/sites/default/files/2023-06/22-088_EEOC_KnowYourRights6.12ScreenRdr.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 https://accessibility.jhu.edu/.

Vaccine Requirements

Johns Hopkins University strongly encourages, but no longer requires, at least one dose of the COVID-19 vaccine. The COVID-19 vaccine does not apply to positions located in the State of Florida. We still require all faculty, staff, and students to receive the seasonal flu vaccine. 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. This change does not apply to the School of Medicine (SOM). SOM hires must be fully vaccinated with an FDA COVID-19 vaccination and provide proof of vaccination status. 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 upon 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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