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.