The Department of Pediatrics, Division of Adolescent & Young Adult Medicine is recruiting for a Full Time Research Assistant. The successful candidate will assist in the day-to-day logistical and operational tasks involving the initiation and management of a study funded by the Patient Centered Outcomes Research Institute (PCORI) that is a randomized comparative effectiveness trial of an alcohol intervention involving brief intervention and mindfulness training in a population of adolescents involving 13 clinical primary care sites in the Greater Baltimore Metropolitan area.

Specific Duties & Responsibilities

• Will be involved in regulatory application, protocol implementation, compliance, recruitment, retention, and completion of participation in a randomized clinical trial involving adolescents ages 12-17, including parents and clinical providers.
• Will comply with all regulatory/IRB guidelines including, but not limited to preparation and submission of study protocols, consent forms, amendments, and annual continuing reviews.
• Will collaborate in development, preparation, and maintenance of regulatory documents.
• Follow all institutional research rules and guidelines.
• Represent study team at study initiation/monitoring meetings.
• Assist with patient screening and enrollment.
  
• Consenting patients for the study.
• Assist with IRB submission.
• Conduct follow up interviews.
• Arrange for reimbursement for patients.
• Assist with organizing study report forms and regulatory binders.
• Screen potential research subjects for participation in a randomized clinical trial; evaluate ongoing eligibility of research subjects’ participation in clinical trial.
• Demonstrate an understanding of the informed consent process.
• Obtain informed consent from research subjects as per protocol.
• In conjunction with Project Coordinator and Evaluation Assistant/Data Manager, monitor protocol enrollment goals and collaborate in the development of recruitment strategies to ensure accrual and retention within goal time frames; demonstrate knowledge of protocol endpoint definitions.
• Assist with ensuring collection of pertinent data from internal and external sources. Monitor compliance with requirements for study participation.
• Schedule, perform, and/or monitor data collection per protocol requirements.
• Ensure and coordinate correct documentation of clinical study in medical record and appropriate protocol documents.
• Schedule visits, and data collection procedures for patients entered in clinical trial per the protocol.
• As appropriate, ensure all required signatures are obtained on informed consent documents and validity of available informed consent documents.
• Perform subject interviews and assessments at study visits for data collection required by protocol, as appropriate.
• Using working knowledge will assist in developing recruitment tools for assigned study(s), which include protocol/study specific data collection forms, drafting and placing approved advertisements, and contacting physicians for possible referrals.
• Maintain tracking database/spreadsheet based on study requirements utilizing Excel, REDCap, or similar software applications.
• Abstract data from patient medical records as per protocol.
• Utilizing working knowledge of study will participate in meetings to provide operational updates, report on any operational issues, and may make recommendations for resolutions to new/outstanding operational issues.
• Ensure that patient data files and accompanying paperwork are organized and current.
• Assists with data analysis, interpretation, manuscript and abstract preparation.
• Must be able to be mobile and travel to the participating clinical sites.
• Must maintain current required research certifications during duration of employment.

Additional Skills, Knowledge and Abilities

• Ability to complete the JHH required training prior to start date.
  
• Able to prioritize workload and manage multiple tasks effectively.
• Ability to achieve and maintain a working knowledge of computer software specific to project, including Microsoft Word and Excel, e-mail, Electronic Medical Record system (Epic) and internet functions.
• Knowledgeable of the Johns Hopkins Institutional Review Board and departmental Standard Operating Procedures.

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

• Master’s Degree in a related field.
• Related research experience.
• Ability to demonstrate knowledge and skills necessary to perform the role as it pertains to research.
• Spanish language proficiency is a desired attribute.

Classified Title: Research Assistant 
Role/Level/Range: ACRO40/E/03/CD  
Starting Salary Range: $17.20 - $30.30 HRLY ($45,563 targeted; Commensurate with experience) 
Employee group: Full Time 
Schedule: Mon-Fri 8:30 am - 5:00 pm 
Exempt Status: Non-Exempt 
Location: Hybrid/School of Medicine Campus 
Department name: ​​​​​​​SOM Ped Adolescent Medicine  
Personnel area: School of Medicine