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.
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.
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.
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