We are seeking a Research Program Manager. The Research Program Manager will lead a collaborative research team in the coordination and implementation of assigned clinical trials within the Huntington Disease Center, with limited supervision from the study Principle Investigators.

Specific Duties & Responsibilities

• Provide overall management for research trials at the HD center.

• Prioritize among multiple studies with differing inclusion/exclusion criteria and different needs for coordinators and other clinic personnel, as well as several different site investigators.

• Work with investigators and admin and budget personnel to assure that resources are available for several studies.

• Manage a complex first-in-human neurosurgical study requiring close coordination with our neurosurgical investigators (as well as both blinded and unblinded neurosurgical and pharmacy personnel) and coordination with clinicians and neurosurgeons at other sites.

• Organize studies involving invasive sterile procedures (eg Lumbar puncture and Intrathecal drug administration) performed in our clinic procedure rooms, and requiring multiple personnel for clinical stat labs as well as research lab preparation of biosamples.

• Collaborate in the development and writing of protocols, consent forms, and investigational drug data sheets as appropriate. patient populations.

• Anticipate research requirements for designated and apply knowledge of study design to evaluate new protocols.

• Ascertain medical history and assesses subjects for inclusion/ exclusion criteria.

• Document all aspects of medical and concomitant issues and drug and other intakes completely.

• List and clarify concerns and questions about new protocols with PI and/or sponsor.

• Develop study tools including data collection forms, eligibility checklists, pre-printed orders, etc.

• Assist in reviewing prospective reimbursement analysis (PRA) as appropriate.

• Create study case report forms as needed.

• Coordinate with data managers to ensure delivery of trial data into study files.

• Prepare drug data sheets for pharmacy and assure submission of the same to CRO/IRB for assigned protocols as appropriate.

• Draft and edit study protocols with limited supervision by PI, contribute to protocol revisions, and recruitment materials, including preparing, submitting, and updating documents for IRBs, DSMBs, study monitors, and central coordinating centers.

• Perform standard data analysis, including preparation of graphs and tables for grants, annual reports, and presentations.

• Assist with the preparation of grant applications, presentations, and manuscripts.

• Assist administrative manager in maintaining an accurate accounting of study costs, revenues, and financial projections.

• Initiate, schedule, and organize meetings with study staff or representatives of monitoring organizations as necessary.

• Assure that all protocol elements of a trial are in place before opening to accrual.

• Create an eligibility checklist for assigned protocols.

• Collaborate in the development of recruitment strategies to ensure patient accrual within protocol time frames.

• Ensure collection of pertinent data from internal and external sources and monitor compliance with requirements of assigned clinical trials.

• With Principal and Sub-Investigators, assist in determining adverse event causality and relationship to study drug/procedure.

• Assess subjects for adverse events and their clinical significance as well as record and documents protocol deviations

• Submit serious unexpected adverse reaction reports to the IRB.

• Ability to manage multiple projects at different stages of the clinical research process.

• Design/coordinate educational programs for patients and families relevant to protocols as needed.

• Provide ongoing education to patients and families regarding the pertinent clinical trial and clinical management issues.

• Monitor subject compliance with the requirements of the study protocol.

• Collaborate with the health care team to coordinate and facilitate protocol requirements for assigned clinical trials to evaluate subject responses to interventions outlined in the study protocol.

• Develop an understanding of the role of the involved Clinical Research Organizations (CROs) and their representative Clinical Research Associates (CRAs).

• Work with CROs and CRAs to fulfill sponsor expectations.

• Work productively with monitors on site.

Supervisory Responsibilities For Junior and Senior Level Staff

• Oversee training, orientation, and supervision of junior and senior staff and students and provide general management support.
  

• Supervise research programs coordinators and senior program coordinators, clinic coordinators, and students and oversee workload distribution across clinical team.
  

• Manage time, effort, and workload for clinic staff.
  

• Ensure that all research staff complete appropriate training/certifications.
  

• Daily performance management and conducting scheduled performance reviews.

Special Knowledge, Skills & Abilities

• Demonstrates knowledge of computer applications of personal computer systems.
  
• Working knowledge of Microsoft Word, excel, and power-point, MS Access experience preferred.
  
• Strong organizational problem-solving and communication skills.
  
• Knowledge of entering irb protocols and updates and interacting with IRB staff is necessary.
  
• Interactions with Johns Hopkins Institutional Review Board preferred.
  
• Ability to demonstrate knowledge and skills necessary to provide care appropriate to the age of the patients served.
  
• Ability to get along with a wide range of people, including those affected by neurological disease.
  
• Highly effective verbal and written communication skills are required.
  
• Current CPR is desired but will provide training and continued recertification.
  

Physical Requirements 

• Able to sit in a normal seated position for extended periods.
  
• Able to reach by extending hand(s) or arm(s) in any direction.
  
• Finger dexterity required, able to manipulate objects with fingers rather than the entire hand(s) or arm(s), e.g., use of a computer keyboard.
  
• Communication skills using the spoken word.
  
• Ability to see within normal parameters.
  
• Ability to hear within normal range.
  

Supervisory Responsibility

• Research Staff, RPA II, RPC

• Bachelor's Degree in related discipline. Related Master's preferred.
• Five years related experience, including demonstrated supervisory or lead responsibilities.
• Additional education may substitute for required experience, to the extent permitted by the JHU equivalency formula.

• Related Master's preferred.
• Experience with multisite clinical trials of drugs is highly desired. Five years of clinical research experience with individuals with neurological or psychiatric disorders is preferred.
• Phlebotomy experience preferred.

Classified Title: Research Program Manager 
Working Title: Research Program Manager   
Role/Level/Range: ACRP/04/MD  
Starting Salary Range: $54,080 -$ 74,390 - $ 94,710 Annually (Commensurate with experience) 
Employee group: Full Time 
Schedule: M-F, 8:30 am to 5 pm 
Exempt Status: Exempt 
Location: Hybrid 
Department name: 10003819-SOM Psy Gen Neurobiology and Schizophren 
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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