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Job Req ID:  17623

Clinical Research QA Specialist

The Clinical Research QA Specialist is focused on the both the Study Compliance and Quality Assurance (QA) of the eCOREs “Research Plans” for the Clinical Research Studies. This includes coordinating and participating in editing new and amended Study Compliance Instructions (SCIs) and the electronic build of individual Research Plan Modules (in eCOREs system). Attends Study Initiation Visits (SIVs) with other members of the eCOREs staff. The qualified candidate has responsibilities associated with this position that include taking instruction from the eCOREs team leader for:

 

  • Reading and thoroughly understanding current study documents (protocols, Lab Manuals, amendment memorandums, etc.) assigned
  • Participate in completing new or amended individual SCI
  • Documenting completed activities in the SCI/Study Plan Databases

 

DUTIES AND RESPONSIBILITIES:

 

Study Compliance and Quality Assurance Activities:

  • Develops Study Compliance Instructions (SCI) design and has primary responsibility for creating and/or updating study specific instructions for implementation in clinical research trials.
  • Uses high-level organizational skills and extensive clinical research expertise to accurately and efficiently review clinical protocols and laboratory manuals (if applicable) and extract critical details to be translated into Study Compliance Instructions (SCIs).
  • The design process may be in collaboration with the PI, the study team, or completed independently.
  • Reviews, analyzes, and interprets clinical protocols and laboratory manuals (if applicable) and extracts critical details to be translated into SCIs. Oversees and assures study compliance with regulatory requirements and JHU standards, policies and procedures.

 

Teamwork Activities:

  • Evaluates data and recommend ways to improve SCI Team efficiency.
  • Supports the SCI staff through training and education.
  • Actively participates in SCI Team meetings.
  • Responds to requests from other departments within mutually agreed upon time frames.
  • Seeks opportunities to assist co-workers.
  • Supports activities that prevent the excessive use of human resources or materials.
  • Other duties as assigned by the Central Processing Operations Director.

 

Minimum Qualifications:

 

Required: Bachelors’ degree in related discipline, and minimum of three years related clinical research experience required.  Advanced degree may be considered in lieu of some experience, to the extent permitted by the JHU equivalency formula.

  

Special Knowledge, Skills, or Abilities / Competencies:

  • Highly motivated, well-organized and detail oriented person with clinical research experience.
  • Ability to critically review clinical protocols and complex laboratory manuals.
  • Good verbal and written communication skills.
  • Excellent time management skills with the ability to multi-task is required.
  • Must be able to work independently.
  • Understand and ensure quality assurance and study compliance for all studies.
  • Knowledge with basic clinical protocol design and terminology.
  • Knowledge of basic specimen acquisition processing and terminology.
  • Working knowledge of Microsoft Office.

 

JHU Equivalency Formula:  18 graduate degree credits may substitute for one year of experience.  

 

 

Classified Title: Sr. Research Assistant 
Working Title: Clinical Research QA Specialist  ​​​​​
Role/Level/Range: ACRP/03/MB 
Starting Salary Range: $38.920 - $53.520/Annually
Employee Group: Full Time 
Schedule: Monday - Friday, 8:30 a.m. - 5:00 p.m. (37.5 Hours/Week) 
Exempt Status: Exempt  
Location: School of Medicine - East Baltimore Campus 
Department Name: Oncology 
Personnel Area: School of Medicine

 

The successful candidate(s) for this position will be subject to a pre-employment background check.

 

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 HR Business Services Office at jhurecruitment@jhu.edu. For TTY users, call via Maryland Relay or dial 711.

 

The following additional provisions may apply depending on which campus you will work.  Your recruiter will advise accordingly.

 

During the Influenza ("the flu") season, as a condition of employment, The Johns Hopkins Institutions require all employees who provide ongoing services to patients or work in patient care or clinical care areas to have an annual influenza vaccination or possess an approved medical or religious exception. Failure to meet this requirement may result in termination of employment.

 

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.

 

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

 

EEO is the Law
Learn more:
https://www1.eeoc.gov/employers/upload/eeoc_self_print_poster.pdf
Important legal information
http://hrnt.jhu.edu/legal.cfm

 

School of Medicine - East Baltimore Campus