The Sr. Clinical Research QA Specialist’s responsibility is focused on both the Study Compliance and Quality Assurance (QA) of the eCOREs “Research Plans” for the Clinical Research Studies. This includes the design, development and implementation of new and amended Study Compliance Instructions (SCIs), the electronic build of individual Research Plan Modules (in eCOREs system), attendance at assigned Site Initiation Visits (SIVs) with investigators, and quality control systems documentation (SCI/Study Plan Databases).The qualified candidate responsibilities include:
Responsibilities for reviewing initial SCI request submitted by clinical programs, and, upon approval, assigning the SCI to individual SCI Team members.
Maintenance of study folders that contain all current study documents (protocols, lab manuals, amendments, memorandums, etc.)
Completing new or amended SCI by the assigned date.
Preparing for and attending assigned SIVs at the designated time/dates.
Updating (in real time) all activities in the SCI/Study Plan Databases.
Consulting with PI’s on protocol development when lab specimens are involved, specifically advising on study collection design and timetables, specimen workflows, and processing procedures.
Consults with industry sponsors on their provided laboratory manuals, including the resolution of any inconsistencies that challenge service core workflows and/or may impact the overall quality assurance and study compliance success.
May act as the SCI Team Leader.
DUTIES AND RESPONSIBILITIES
Study Compliance and Quality Assurance Activities:
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).
Performs all aspects of SCI and eCORE Research Plan builds and updates with study compliance being the top priority.
Coordinates directly with the investigator, study team and sponsor to ensure study compliance is defined clearly and applied to the SCI/eCOREs Research Plan.
Thoroughly reviews draft study protocols/lab manuals, prepares specific questions, identifies clarifications required for scheduled SIVs.
Assists with the verification process of SCIs completed by the SCI Team.
Communicates to SCI Team all relevant information related to SCIs and eCOREs Research Plans during and after the development and implementation process.
Investigates study compliance deviations and recommends any revisions to SCIs.
Assists with providing completed SCI/eCORE Research Plans to study teams.
Evaluates data and uses direct observations to identify and recommend ways to improve SCI Team efficiency and clinical research compliance.
Supports the SCI staff through training and education.
Actively participates in SCI Team meetings and Investigator 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.
Bachelor’s degree required, preferably in health-related sciences. Master’s degree in relevant field preferred. Requires a minimum of 5 years of experience in clinical research at an academic, government, or pharmaceutical industry environment. Experience in protocol development helpful. Advanced related degree can substitute for some experience, to the extent permitted by the JHU equivalency formula.
In-depth clinical trial knowledge and demonstrated competency in required materials such as clinical protocols and laboratory manuals provided by pharmaceutical companies on clinical investigators.
Demonstrated performance to provide leadership, training, and problem-solving for a clinical core team.
Experience in managing administrative issues for clinical core services.
Special Knowledge, Skills, or Abilities / Competencies:
Highly motivated, very 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 and when circumstances require it, represent the team during meetings or other communications with investigators, study team members and sponsors.
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: Clinical Research Program Specialist Working Title: Sr. Clinical Research QA Specialist Role/Level/Range: ACRP/04/MC Starting Salary Range: $45,195 - $62,225/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
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