Clinical Research Study Coordinator
POSITION DESCRIPTION: Coordinates all aspects of clinical research studies of lupus patients and healthy controls. Performs participant recruitment and enrollment, medical records data extraction, and scheduling/follow-up for sample collection. Other duties include assisting the study Principal Investigator in collection, analysis and evaluation of clinical/medical data required progress reports to Institutional Review Board (IRB), granting, and other regulatory agencies.
- Subject Recruitment. Works with study Principal Investigator and company recruiting personnel to develop and distribute participant recruiting materials.
- Participant Enrollment. Responsible for conducting participant screening interview to determine that eligibility criteria are met for study enrollment. Completes consent process, enrollment, and clinical history of eligible participants.
- Medical/Clinical Data Extraction and Analysis. Reviews medical histories and extracts data required for completing study goals. Organizes study data which may include performing data entry, analysis, and preparation of data tables for reports. Ensures data entry is accurate and completed in a timely manner.
- IRB Coordination. Assists Principal Investigator in preparing progress reports for IRB. Ensures clinical research studies are being conducted in compliance with IRB human subject regulations. Develops recruitment materials, study protocols, and consent forms for clinical research studies.
- Sample Collection. Coordinates and schedules participant blood sampling at contracted draw sites or in home mobile phlebotomy services. Manages the request, collection, labelling, storage, or shipment of samples.
- Follow Up. Responsible for the initiation, organization, and handling of patient follow-up.
- General. As needed, performs various duties as needed to successfully fulfill the functions of the position.
Bachelor’s Degree in Nursing or Related Health Profession, Biological Sciences, or Associates Degree and 24 months of equivalent work experience.
Preferable: 12 months experience in clinical research study enrollment/coordination, clinical trials management, nursing, healthcare, or social sciences.
Preferable: Training and experience in performing phlebotomy.
Preferable: Certifications in Nursing, Registered Health Information Technician (RHIT) or related areas.
- Under general supervision, performs independently and as an entry-level professional
- Has a general understanding of research concepts, guidelines, principles, and practices
- Performs duties within company established programs, policies, and guidelines
Knowledge of protocol guidelines, principles, and practices
- Ability to ask questions to determine proper course of action following established standards
- Demonstrates the ability to learn and effectively utilize all applicable business software including, but not limited to: practice management software, EMR software, Word, Excel, Outlook, and Power Point
- Excellent oral and written communication skills, planning, and organizational skills including task prioritization
- Problem solving and effective decision-making skills
- Possesses leadership and conflict resolution skills
- Must work independently and as a team member
- Ability to handle multiple tasks and solve problems in stressful situations
Job Type: Full-time
Hiring is contingent upon a Background Check
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