Clinical Research Coordinator III

Jacksonville, FL - USA

Yearly Salary: $ 70000 - 80000

Posted on: Yesterday

Vacancies: 1 Vacancy

Job Summary

Classification Title:	Clinical Research Coordinator III
Classification Minimum Requirements:	Bachelors degree in an appropriate area and three years of relevant experience; or an equivalent combination of education and experience.
Job Description:	Quality Assurance and Oversight Conduct periodic quality assurance reviews of clinical research documentation including source data case report forms and regulatory files to ensure GCP and institutional compliance. Identify findings develop corrective and preventive action (CAPA) plans and track resolution through completion. Support readiness for sponsor federal and internal audits by maintaining accurate and complete research documentation. Develop and deliver QA tools checklists and training resources for study teams and faculty. OnCore CTMS Management Ensure data integrity and standardization across protocols coordinating with research finance compliance and departmental teams. Generate OnCore reports to support leadership oversight and operational decision-making. Veeva eRegulatory System Oversee the maintenance of electronic regulatory binders in Veeva eRegulatory to ensure complete accurate and compliant documentation. Conduct regular quality control checks of study regulatory files and assist in resolving discrepancies. Support and train faculty and staff in the use of Veeva for document submission routing and approval workflows. IRB and Regulatory Compliance Liaise between the study team IRB and other institutional offices to ensure timely and compliant submissions. Maintain awareness of current institutional federal and sponsor regulations impacting human subjects research.
Expected Salary:	$70000- $80000 per year
Required Qualifications:	Bachelors degree in an appropriate area and three years of relevant experience; or an equivalent combination of education and experience.
Preferred:	Masters degree or an allied health professional degree in an appropriate area and 5 years of experience coordinating or managing clinical research in an academic medical center or hospital-based environment preference for experience in performing quality assurance reviews on clinical trial adherence. Education & Experience: Bachelors degree in a health-related scientific or regulatory discipline and three years of relevant experience; or an equivalent combination of education and experience. Demonstrated experience using CTMS eRegulatory and electronic IRB submission systems. Strong knowledge of ICH-GCP FDA OHRP and institutional research regulations and standards. Skills & Competencies: High attention to detail and strong organizational skills. Excellent interpersonal written and verbal communication abilities. Ability to manage multiple priorities and meet deadlines in a complex academic environment. Proven ability to work collaboratively across departments and disciplines. Proficiency with Microsoft Office Suite and research management applications.
Special Instructions to Applicants:	This is a time-limited position. Time limited positions are based on circumstances such as funding sources which control the length of time for which the position is available. Background Check is Required. To be considered you must upload your Cover Letter Resume/CV and 3 References. University of Florida College of Medicine Jacksonville: Visit this link to watch the video. Application must be submitted by 11:55 p.m. (ET) of the posting end date.
Health Assessment Required:	Yes

Required Experience:

Classification Title:Clinical Research Coordinator IIIClassification Minimum Requirements:Bachelors degree in an appropriate area and three years of relevant experience; or an equivalent combination of education and experience.Job Description:Quality Assurance and Oversight Conduct periodic quality ...

Classification Title:	Clinical Research Coordinator III
Classification Minimum Requirements:	Bachelors degree in an appropriate area and three years of relevant experience; or an equivalent combination of education and experience.
Job Description:	Quality Assurance and Oversight Conduct periodic quality assurance reviews of clinical research documentation including source data case report forms and regulatory files to ensure GCP and institutional compliance. Identify findings develop corrective and preventive action (CAPA) plans and track resolution through completion. Support readiness for sponsor federal and internal audits by maintaining accurate and complete research documentation. Develop and deliver QA tools checklists and training resources for study teams and faculty. OnCore CTMS Management Ensure data integrity and standardization across protocols coordinating with research finance compliance and departmental teams. Generate OnCore reports to support leadership oversight and operational decision-making. Veeva eRegulatory System Oversee the maintenance of electronic regulatory binders in Veeva eRegulatory to ensure complete accurate and compliant documentation. Conduct regular quality control checks of study regulatory files and assist in resolving discrepancies. Support and train faculty and staff in the use of Veeva for document submission routing and approval workflows. IRB and Regulatory Compliance Liaise between the study team IRB and other institutional offices to ensure timely and compliant submissions. Maintain awareness of current institutional federal and sponsor regulations impacting human subjects research.
Expected Salary:	$70000- $80000 per year
Required Qualifications:	Bachelors degree in an appropriate area and three years of relevant experience; or an equivalent combination of education and experience.
Preferred:	Masters degree or an allied health professional degree in an appropriate area and 5 years of experience coordinating or managing clinical research in an academic medical center or hospital-based environment preference for experience in performing quality assurance reviews on clinical trial adherence. Education & Experience: Bachelors degree in a health-related scientific or regulatory discipline and three years of relevant experience; or an equivalent combination of education and experience. Demonstrated experience using CTMS eRegulatory and electronic IRB submission systems. Strong knowledge of ICH-GCP FDA OHRP and institutional research regulations and standards. Skills & Competencies: High attention to detail and strong organizational skills. Excellent interpersonal written and verbal communication abilities. Ability to manage multiple priorities and meet deadlines in a complex academic environment. Proven ability to work collaboratively across departments and disciplines. Proficiency with Microsoft Office Suite and research management applications.
Special Instructions to Applicants:	This is a time-limited position. Time limited positions are based on circumstances such as funding sources which control the length of time for which the position is available. Background Check is Required. To be considered you must upload your Cover Letter Resume/CV and 3 References. University of Florida College of Medicine Jacksonville: Visit this link to watch the video. Application must be submitted by 11:55 p.m. (ET) of the posting end date.
Health Assessment Required:	Yes