• Job Description

  Req#: 114673

  Our research team is looking for a Research Assistant with excellent, self-motivated, goal-oriented, organized, team player attributes. Position will be in the Bayview Division of General Gyn/Ob of the Department of Gynecology and Obstetrics. Our ongoing projects related to uterine fibroids include clinical, laboratory and statistical work. The studies are the simvastatin fibroid study and the senescence in uterine fibroid study. We also have the study of impact of COVID vaccination on menstruation and other studies to understand the physiology and disorders of menstruation. These studies need enrolling participants, collecting and analyzing data, and collecting biospecimens. The Research Assistant will also participate in the laboratory part of the project including the animal studies, cellular and molecular experiments as appropriate. Will perform basic level statistical analysis under the direct supervision of the Principal Investigator and will be included in other projects as assigned.

  
  

  Specific Duties & Responsibilities
  

  • Involved in the research program including clinical studies in compliance with institutional and federal regulations.
  • When appropriate, get involved with the start-up phase through to the completion phase of the clinical trial.
  • Will be involved in regulatory application, protocol implementation, compliance, recruitment, retention, and final completion of the trial.
  • Complies 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.
  • Collaborate in determination of roles and responsibilities of study team members in the implementation of assigned clinical studies.
  • Collaborate in the development of study tools including data collection forms, eligibility checklists, and pre-printed orders.
  • Follow all institutional research rules and guidelines.
  • Represent study team at study initiation meetings.
  • Assist with organizing case report forms and regulatory binders.
  • Screen potential research subjects for participation in clinical trials; evaluate ongoing eligibility of research subjects’ participation in clinical trials.
  • Demonstrate an understanding of the informed consent process.
  • Obtain informed consent from research subjects as per protocol and document obtaining of informed consent in the medical record.
  • In conjunction with PI, 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 of assigned clinical trials.
  • Maintain Data sources consistent with GCP guidelines and respective protocols.
  • Obtain and ensure proper distribution of required pharmacokinetic & tissue samples.
  • Schedule, perform, and/or monitor procedures and tests per protocol requirements.
  • Ensure and coordinate correct documentation of clinical study in medical record and appropriate protocol documents. Schedule visits, tests and procedures for patients entered in clinical trials 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.
  • Apply pharmacologic knowledge to assist PI in determining adverse event causality and relationship to study drug/procedure. As appropriate, performs phlebotomy per policy and procedures, and documents per institutional standards.
  • Make return (monthly) participant visits and coordination as well as, blood draws in addition to clinical assessments.
  • High degree of understanding of research and applies general analytical skills to administer the logistical implementation of assigned projects, and to identify situations requiring special attention.
  • Utilizing this knowledge, will ensure adherence to research protocols, operating procedures, and all associated internal/external regulations.
  • 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.
  • Develop moderately complex tracking database/spreadsheet based on study requirements utilizing Excel, REDCap, or similar software applications.
  • Abstract data from patient medical records that requires some interpretation. Monitors data quality and accuracy as required by research protocol. Will run pre-established queries and may develop ad-hoc queries/reports as requested.
  • Utilizing working knowledge of study(s) will participate in meetings to provide operational updates, report on any operational issues, and may make recommendations for resolutions to new/outstanding operational issues.
  • Will coordinate study(s) meetings, including developing an agenda and coordinating information and participation of individuals from other institutions.
  • Oversee budget expenditures based on the study(s) operational expectation.
  • Will act as the primary contact for study participants, including scheduling, confirming appointments, and escorting/directing to various locations on/off campus.
  • Ensure that case files and accompanying paperwork are organized and current.
  • Assists with data analysis, interpretation, manuscript and abstract preparation. Although training in statistical analysis is not a requirement, familiarity with data analysis software is a plus.
  • The Research Assistant will participate in laboratory molecular, cellular and animal experiments as appropriate. This includes cell culture, imaging, basic assays such as PCR, Western Blotting, Flowcytometry, ELISA, and others.
  • The animal experiments include basic handling of research mice, ability to order them, follow up in the animal facility, administering anesthesia, basic surgical skills, xenograft placement, specimen collection and euthanasia.
  • Opportunity for participation in scholarly activity and paper authorship.

  
  

  Specific Knowledge, Skills & Abilities

  • Must maintain current required research certifications during duration of employment.
  • Completion of the JHH required training prior to start date.
    
  • Able to prioritize workload and manage multiple projects effectively.
    
  • Must achieve and maintain a working knowledge of computer software specific to department, 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.

  
  
  Minimum Qualifications
  

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

  
  
  Preferred Qualifications
  

  • 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 women reproductive health research.

  Classified Title: Research Assistant
  Job Posting Title (Working Title): Research Assistant
  Role/Level/Range: ACRO40/E/03/CD
  Starting Salary Range: $17.00 - $30.00 HRLY (commensurate with experience)
  Employee group: Part-time
  Schedule: Mon-Fri 8:00 am - 5:00 pm
  Exempt Status: Non-Exempt
  Location: School of Medicine Campus
  Department name: SOM OB GYN Bay Gynecology Obstetrics Bay
  Personnel area: School of Medicine

• About the company

  The Johns Hopkins University is a private research university in Baltimore, Maryland.

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