Clinical Research Coordinator I Pediatrics CHRI

Pediatrics CHRI

Job Location:

Gainesville, FL - USA

Yearly Salary: $ 46000 - 50000

Posted on: 4 hours ago

Vacancies: 1 Vacancy

Job Summary

Classification Title:	Clinical Research Coord I
Classification Minimum Requirements:	Associates degree or an allied health professional degree in an appropriate area and one year of relevant experience; or an equivalent combination of education and experience.
Job Description:	The Clinical Research Coordinator I position described herein will coordinate simple clinical research studies and assist in the coordinator of complex clinical research studies in the Department of Pediatrics Child Health Research Institute. All clinical studies will focus on inherited muscular diseases. The incumbent will be responsible for coordinating all aspects of assigned simple clinical trials and assisting more experienced coordinators managing complex clinical research studies. Activities include 1. Onboarding new clinical studies following institutional workflows and requirements; 2. Obtaining and maintaining regulatory compliance; 3. Verifying study-related charges following institutional and departmental timelines; 4. Serving as the point of contact for all administrative matters related to assigned studies; 5. Enrolling patients into assigned clinical studies; 6. Coordinating patient and study monitor site visits; and 7. Presenting study updates at weekly team meetings. The Clinical Research Coordinator I position will join a team of coordinators that focuses on inherited muscular diseases. The Clinical Research Coordinator I will coordinate assigned simple clinical research studies while simultaneously assisting senior team members on more complex clinical research studies. The Clinical Research Coordinator I must be able to perform the following essential functions independently: Coordinate clinical research studies Activities include and are not limited to: recruiting patients to enroll in study(ies); coordinating patient visits; managing patient visits in accordance to protocol; coordinating site monitor visits; submitting necessary compliance paperwork; ensuring billing compliance; resolving issues/questions with the sponsor; serving as the liaison between the Principal Investigator and study subjects; performing study feasibility assessments for potential new studies. Clinical trial regulatory compliance management for clinical studies managed and assisting. Activities included but are not limited to: initiating and maintaining a current regulatory file; preparing and submitting documents related to clinical trials to both internal (UF-IRB UF-OCR UF-IBC etc.) and external (FDA RACWCG etc) organizations as required; completing end of study procedures; scheduling and participating in sponsored research monitoring visits; assuring that the clinical research trials integrity and quality are maintained and that the trial is conducted following Good Clinical Practice guidelines; attending UF-IRB 01 full board meetings as necessary. Assist senior team members on more complex clinical research studies. Assisting research managerand other team members with regulatory submissions as needed. Miscellaneous Activities Activities include but are not limited to: completing tasks as assigned to complete clinical trial(s); Satisfying annual competencies as required by the University of Florida and Institutional Review boards; participating in professional development and continuing education.
Expected Salary:	$46000 - $50000 annually; commensurate within this range based on qualifications and experience.
Required Qualifications:	Associates degree or an allied health professional degree in an appropriate area and one year of relevant experience; or an equivalent combination of education and experience.
Preferred:	Bachelors Degree Knowledge and experience with clinical trial research process and policies Proficiency in all Microsoft Office applications; ability to communicate effectively both verbally and in writing Excellent interpersonal skills Prior experience of direct patient contact preferred Prior experience working with inherited muscular diseases
Special Instructions to Applicants:	This is a Time-Limited position. To be considered for this position please upload your cover letter or letter of interest resume and a list of professional references. 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 Coord IClassification Minimum Requirements:Associates degree or an allied health professional degree in an appropriate area and one year of relevantexperience; or an equivalent combination of education and experience.Job Description:The Clinical Research Coordi...

Classification Title:	Clinical Research Coord I
Classification Minimum Requirements:	Associates degree or an allied health professional degree in an appropriate area and one year of relevant experience; or an equivalent combination of education and experience.
Job Description:	The Clinical Research Coordinator I position described herein will coordinate simple clinical research studies and assist in the coordinator of complex clinical research studies in the Department of Pediatrics Child Health Research Institute. All clinical studies will focus on inherited muscular diseases. The incumbent will be responsible for coordinating all aspects of assigned simple clinical trials and assisting more experienced coordinators managing complex clinical research studies. Activities include 1. Onboarding new clinical studies following institutional workflows and requirements; 2. Obtaining and maintaining regulatory compliance; 3. Verifying study-related charges following institutional and departmental timelines; 4. Serving as the point of contact for all administrative matters related to assigned studies; 5. Enrolling patients into assigned clinical studies; 6. Coordinating patient and study monitor site visits; and 7. Presenting study updates at weekly team meetings. The Clinical Research Coordinator I position will join a team of coordinators that focuses on inherited muscular diseases. The Clinical Research Coordinator I will coordinate assigned simple clinical research studies while simultaneously assisting senior team members on more complex clinical research studies. The Clinical Research Coordinator I must be able to perform the following essential functions independently: Coordinate clinical research studies Activities include and are not limited to: recruiting patients to enroll in study(ies); coordinating patient visits; managing patient visits in accordance to protocol; coordinating site monitor visits; submitting necessary compliance paperwork; ensuring billing compliance; resolving issues/questions with the sponsor; serving as the liaison between the Principal Investigator and study subjects; performing study feasibility assessments for potential new studies. Clinical trial regulatory compliance management for clinical studies managed and assisting. Activities included but are not limited to: initiating and maintaining a current regulatory file; preparing and submitting documents related to clinical trials to both internal (UF-IRB UF-OCR UF-IBC etc.) and external (FDA RACWCG etc) organizations as required; completing end of study procedures; scheduling and participating in sponsored research monitoring visits; assuring that the clinical research trials integrity and quality are maintained and that the trial is conducted following Good Clinical Practice guidelines; attending UF-IRB 01 full board meetings as necessary. Assist senior team members on more complex clinical research studies. Assisting research managerand other team members with regulatory submissions as needed. Miscellaneous Activities Activities include but are not limited to: completing tasks as assigned to complete clinical trial(s); Satisfying annual competencies as required by the University of Florida and Institutional Review boards; participating in professional development and continuing education.
Expected Salary:	$46000 - $50000 annually; commensurate within this range based on qualifications and experience.
Required Qualifications:	Associates degree or an allied health professional degree in an appropriate area and one year of relevant experience; or an equivalent combination of education and experience.
Preferred:	Bachelors Degree Knowledge and experience with clinical trial research process and policies Proficiency in all Microsoft Office applications; ability to communicate effectively both verbally and in writing Excellent interpersonal skills Prior experience of direct patient contact preferred Prior experience working with inherited muscular diseases
Special Instructions to Applicants:	This is a Time-Limited position. To be considered for this position please upload your cover letter or letter of interest resume and a list of professional references. Application must be submitted by 11:55 p.m. (ET) of the posting end date.
Health Assessment Required:	Yes