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Data & Quality Specialist (Clinical Research Specialist)

Job Summary

Department-Specific Responsibilities
  • Engages with researchers to evaluate their needs for research support from the Biospecimen Collection and Banking Core.
  • Aggregates data and tissue resources to meet investigator needs.
  • Supports team in following SOPs and other regulatory requirements.
  • Submits required regulatory paperwork.
  • Performs quality control on existing data and tissue resources.
  • Evaluates surgery schedules to identify/target potential participants in biobanking efforts.
General Responsibilities 
  • Assists with identifying and recruiting potential research study subjects; determines eligibility according to the IRB/protocol approved methodologies, coordinates study procedures, and monitors the progress of research studies or projects.
  • Conducts study visit activities and coordinates screening, consenting, and scheduling of test, exams, and/or non-medical/behavioral interventions and assessments involving study subjects; coordinates, facilitates, and performs various study activities; manages all follow-up activities with subjects based on protocols.
  • Records study data, samples, and/or results in various databases; maintains databases for subjects and subject scheduling; performs data validation checks and pursues resolutions to erroneous data; produces various reports in response to requests from PI, sub-investigators, and/or other study stakeholders.
  • Monitors study team compliance with protocol and SOPs; submits all regulatory paperwork required; communicates with PI and sub-investigators about concerns or recommended changes in study protocols, etc.
  • Assists with developing various communications and strategies for advertising and recruitment, as well as in developing information materials for study participants.
  • Stays up-to-date on regulatory affairs and/or clinical research best practices by attending continuing education classes, conferences, seminars, and project team meetings.
  • Provides various other clinical research study or project support as needed (such as assisting with budget development, invoicing for adverse events, billing compliance and patient billing resolution).
  • May provide guidance and/or support to less experience clinical research staff.

Qualifications

EDUCATION / WORK EXPERIENCE
Required
  • Bachelor's degree in science or a health-related field and 1 year of health-related or research experience; OR
  • Associate degree in an allied health profession and 3 years of health-related or research experience.
Combinations of related education and experience may be considered.
SKILLS
Required
  • Proficient communication skills.
  • Maintains a high degree of professionalism.
  • Demonstrated time management and priority setting skills.
  • Demonstrates a high commitment to quality.
  • Possesses flexibility to work in a fast paced, dynamic environment.
  • Highly thorough and dependable.
  • Possesses a high degree of initiative.
  • Ability to build strong customer relationships.