Quality Assurance Coordinator - Cancer Research And Biostatistics (CRAB)
Cancer Research And Biostatistics (CRAB) is a non-profit organization whose purpose is to help conquer cancer and other diseases through the application of biostatistical principles and data management methods.
Under supervision of the Data Management Department, the Quality Assurance Coordinator (QAC) plans and executes quality control procedures for Data Coordinators (DC) in support of CRAB research. Acts as liaison and reference resource to participating institutions’ Clinical Research Associates (CRAs) and other project personnel. Performs quality review and evaluation of study data. Interacts with Biostatisticians and other study team personnel, participating in activities necessary to enhance and maintain data management functions for specific scientific committee(s) and/or projects as assigned.
The QAC works independently to address quality issues by creating and executing Quality Assurance plans and documenting their results in order to demonstrate the validity of study results. Conducts regular review of completed chart evaluations done by data management staff and provides feedback to DCs and management on DC work quality. Tact is used in communicating with other team members regarding problems uncovered during testing, QA review and/or full data analysis. The QAC is also an active Clinical Research Data Coordinator, therefore responsible for items outlined in the DC I-II-III job descriptions.
Primary Duties and Responsibilities:
- Uses, reviews and updates established Quality Control procedures for data management
- Participates as a team member within specific scientific committee(s) and/or study teams
- Engages in planning, implementing and managing clinical studies from initial concept through closure to ensure studies are in compliance with SOPs, regulations and ICH/GCP guidelines
- Participates in the design and development of clinical trial protocols and case report forms
- Evaluates DC work quality against existing standards. Documents discrepancies according to standardized formats/procedures
- Identifies team members responsible for correcting any problem(s) identified and communicates as necessary to mitigate/resolve them
- Enters review results into the database
- Provides internal QA training sessions
- Reviews raw data across all patients enrolled to a study, identifying questionable, missing and/or incorrect entries and suggesting additional/revised edit checks for future submissions
- Identifies data clean-up projects, runs reports and tracks progress for completion
- Provides coding and procedural guidance to internal staff and external customers
- Assists in the development and revision of departmental standard operating procedures
- Participates in internal system audits and vendor assessments at the discretion of upper management
- Functions as a resource for DCs
- Maintains contact with study teams to ensure protocol compliance and overall study objectives
- Acts as liaison and reference resource to personnel, institutional CRAs, nurses and investigators
- Assists with regulatory and safety issues as requested or required
- May also have responsibilities for one or more complex clinical trials
- Performs other duties as assigned
- BA/BS in health, life sciences, similar field, or four years of experience in clinical trials research setting
- PLUS an additional six years of clinical trials research experience. Graduation from a research related certification program or certification in a recognized research related professional society (SoCRA, SCDM, ACRP) may be substituted for three of the additional six years of clinical trials research experience
- Comprehensive knowledge of and proficiency using electronic data capture systems
- Experience mentoring/training other staff
- Significant knowledge of anatomy/physiology, medical terminology, ICH/GCP Guidelines and AJCC TNM staging
- Solid familiarity with statistics
- Excellent written and oral communication skills
- Good interpersonal skills
- Demonstrated understanding of computer-based systems and ability to learn new software quickly
Desired Knowledge, Skills and Abilities:
- Spanish language skills highly desirable
- Experience with both industry and government funded clinical trials
- Familiarity with validation requirements to register a study with the FDA
- Demonstrated organizational skills with attention to detail
- Experience writing scripts to create lists and reports utilizing Oracle SQL Developer
- Proven ability to use sound judgment and diplomacy while interacting with staff and participating study sites
- Graduation from a research related certification program
- Certification in a recognized research related professional society
This is a full-time position and is Non-Exempt from state and federal overtime regulations.
Employment authorization is required.
Travel/relocation expenses will not be provided for this position.
CRAB is an Equal Opportunity Employer.