CLINICAL RESEARCH COORDINATOR I
UAB Medicine
university, fl, usa
Posted on Tuesday, April 30, 2024
CLINICAL RESEARCH COORDINATOR I - (T216574)
Description
The University of Alabama at Birmingham (UAB), Department of Ped - Neonatology, is seeking a Clinical Research Coordinator I. This position will provide and support all aspects of coordination for clinical research. Tasks will include subject screening, recruitment, consenting, protocol-driven nursing skills, data collection and assessments, AE and SAE assessments; communicating with the research team and the principal investigator, and working with sponsors and monitors; mentoring and training junior staff.
General Responsibilities
- To collect and record preliminary data for clinical research programs.
- To recruit and perform follow-up with research participants as protocols outline.
- To schedule visits according to research protocols.
- To assist in coordination of lab and fieldwork.
- To maintain familiarity with appropriate Good Clinical Practice (GCP) guidelines and regulations.
Key Duties & Responsibilities
- Collect, prepare, process, ship, and maintain inventory of research specimens and train others in these tasks.
- Assist with addressing and correcting findings from study monitoring and study audit visits.
- Collect, prepare, or process adverse event information independently.
- Complete and submit adverse event reports.
- Screen participants for all studies independently.
- Identify and explain the risks and benefits to a subject as these pertain to a clinical trial.
- Employ strategies to maintain recruitment and retention rates, and to assist participants with individual needs.
- Evaluate processes to identify issues related to recruitment and retention rates.
- Conduct and document consent for participants in a variety of studies independently.
- Independently maintain appropriate study-level documentation including regulatory binders, enrollment logs, patient registration in the system of record, etc.
- Develop UAB IRB documents such as consent forms, protocols, and continuing reviews independently.
- Communicate to research participants, both orally and written, the difference between clinical activities and research activities.
- Assist junior staff in the ethical conduct of research, and provide guidance in strategies used to maintain safety.
- Use required processes, policies, and systems to ensure data security and provenance.
- Recognize and report vulnerabilities related to security of physical and electronic data. May serve as mentor to other staff.
- Maintain training requirements and develop solutions to proactively ensure study team members' compliance with training requirements.
- Map a protocol's data flow plan: data capture, storage, management, quality, and preparation for analysis.
- Use Electronic Data Capture (EDC) systems, technologies, and software necessary for study operations with little assistance.
- Enter data accurately.
- Score tests and measures according to protocol, and appropriate to the role.
- Performs other duties as assigned.
Annual Salary Range: $41,175 - $66,915
Qualifications
High School diploma or GED required.
Primary Location
: UniversityJob Category
: Clinical ResearchOrganization
: 311653200 Ped - NeonatologyEmployee Status
: Regular Shift: Day/1st Shift
Work Arrangement (final schedule to be determined by the department/hiring manager): Onsite