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Clinical Research Coordinator II
4 months ago
Description:
The Clinical Research Coordinator supports the clinical departments and the Central Research Department (CRD) conducting research for healthcare system. The Clinical Research Coordinator will assist the Research team to complete all research required services and the Research Finance Team to facilitate accurate patient registration and billing. Responsibilities include: -Patient registration -Data collection -Data submission -Adverse event reporting -Patient follow-up -Records management -Regulatory reporting -Quality assurance -Other activities related to research. PRIMARY DUTIES AND RESPONSIBILITIES: 1. Review and verify subject eligibility based on study inclusion/exclusion criteria 2. Identify, recruit and screen potential clinical study participants 3. Obtain informed consent from patients in coordination with the Investigator 4. Coordinate clinical care with investigator pursuant to the protocol, and in accordance with hospital policy 5. Coordinate, and perform, clinical procedures during research visits (i.e. vital signs, blood draws, EKGs, drug administration, drug dispensing, and other clinical activities as necessary and capable) in conjunction with appropriate training/certification and following hospital policy. Assists clinical staff responsible for research patient visits to complete the research requirements 6. Coordinate diagnostic tests including laboratory tests, radiologic tests, and other tests required by the study 7. Coordinate the collection and processing of research specimens: blood, urine, tissue, etc., to ensure adherence of protocol requirements 8. Identify, evaluate, and complete all adverse events and severe adverse events and report accordingly with the assistance of the research team 9. Secure patient records and source documentation for sponsor monitoring and internal/external audits 10. Communicate with study sponsors in collaboration with the research team and investigator 11. Assure that all federal, state, local, and hospital laws and regulations are adhered to, as they relate to the protection of human subjects and to research compliance 12. Provide backup coverage for other Research Team members when necessary (travel to other sites may be required) 13. Obtains, and maintains database access. Enters data as needed. 14. Practices proper safety techniques in accordance with hospital and departmental policies and procedures and immediately reports any mechanical or electrical equipment malfunctions, unsafe conditions, or employee, patient, visitor injury or accident to the assigned Manager.
Skills:
Clinical research, Oncology, Gcp, healthcare, inpatient, CCRP or CCRC Certificate, patient recruitment, Data entry
Top Skills Details:
Clinical research,Oncology,Gcp,healthcare
Additional Skills & Qualifications:
REQUIRED QUALIFICATIONS: High school diploma or equivalent with at least five (5) years of relevant work experience as a Clinical Research Coordinator; OR Graduate of an accredited school of practical nursing with current and unencumbered licensure as a Licensed Practical Nurse in the State of Georgia and one (1) year relevant work experience in a clinical setting OR Bachelor of Arts or Bachelor of Science degree from an accredited college or university in a data driven research - related field (such as allied health, biological sciences, chemistry, economics, mathematics, psychology, sociology, demography, geography, anthropology, statistics, data science) and one (1) year or less of work experience in a clinical or healthcare setting If not Certified Clinical Research Coordinator (CCRC) or Certified Clinical Research Professional (CCRP) at time of hire, must achieve professional certification through the Association of Clinical Research Professionals (ACRP) or Society of Clinical Research Associates (SOCRA) within three (3) years of hire. Current and valid American Heart Association Basic Life Support (BLS) Provider CPR & AED Program card.
Experience Level:
Intermediate Level
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