Department:
SOM KC Cancer Center Clinical Trials
-----
Clinical Trials Clinical OperationsPosition Title:
Clinical Research Coordinator Community Site Float
Job Family Group:
Professional Staff
Job Description Summary:
This position is responsible for working collaboratively with multidisciplinary teams, research and hospital staff to recruit, screen, educate, and assist in the overall clinical study coordination of clinical research. The Clinical Research Coordinator will manage clinical research studies by coordinating and participating in a variety of complex activities involved in the collection, compilation, documentation and analysis of clinical research data. Monitor participants’ progress including documenting and reporting adverse events. Participate in periodic quality assurance audits of protocols.
Job Description:
The Clinical Research Coordinator (CRC) is responsible for working collaboratively with multidisciplinary teams, research and hospital staff to recruit, screen, educate, and assist in the overall clinical study coordination of clinical research. The CRC will manage The University of Kansas Cancer Center clinical research studies by coordinating and participating in a variety of complex activities involved in the collection, compilation, documentation and analysis of clinical research data. Monitor participants’ progress including documenting and reporting adverse events. Participate in periodic quality assurance audits of protocols.
Individual filling this role will spend 2 days at our North Community Site - 8700 North Green Hills Rd., and 2 days at our Lee's Summit Community Site - 4881 NE Goodview Circle, Lee's Summit. The other day will at either clinic based on need.
The University of Kansas Cancer Center is the region's only National Cancer Institute-designated cancer center where patients gain access to the most promising therapies, cutting-edge clinical trials and world class research.
Join our clinical trials team where you can make a difference!
The starting salary is between the minimum and midpoint of the salary range listed.
Required Qualifications:
- Education: Associate’s degree plus two years related work experience OR an equivalent combination of relevant post secondary education and work experience that equals at least 4 years.
- Experience: Minimum of one year experience as a clinical research coordinator or two years healthcare experience with patient interaction or related experience. Basic understanding of regulations governing clinical research (CFR, GCP, HIPAA). Solid understanding of statutes and guidelines relevant to regulatory affairs in clinical research. Knowledgeable of study budgets, contracts and grant applications.
- Skills: Excellent communication, writing, organizational and presentation skills. Ability to effectively interact with multidisciplinary teams including physicians, administrative staff. Ability to recognize competing priorities and deadlines and seek guidance in management of these where needed. Willingness to seek research certifications to further skills in the position.
Preferred Qualifications:
- Research certification preferred such as Socra certification or certification eligible: Certified Clinical Research Coordinator (CCRC) or certification eligible, Certified Clinical Research Professional (CCRP) or certification eligible Collaborative Institutional Training Initiative (CITI) training certification or certification eligible.
- Skills: Ability to read, speak and write Spanish preferred.
Job Duties Outlined:
- Under the direction of the principal investigator, recruit and educate potential patients for and evaluate potential patient eligibility for clinical trials.
- Maintain source documents and submit case report forms (CRFs) as required for clinical trials.
- Recognize and report adverse events/serious adverse events to the Principal Investigator, FDA, and sponsors.
- Perform study procedures, as outlined in the protocol and within state and institutional scope of practice.
- Assist clinical staff with sample collection, processing, handling, and shipping as outlined in the protocol and within institutional/KUMC policy.
- Ensure adequate study supplies are being maintained. Track study expenditures and submit reimbursement requests for study equipment, supplies and study participants.
- Prepare documentation and participate in study monitoring visits, reviews and audits. Provide written and verbal reports to Principal Investigator and Project Manager, as required.
- Participate in quality assurance activities by reviewing clinical data in medical record charts, assessing pharmacy compliance with protocol criteria and reviewing study documentation to ensure compliance with GCP guidelines and FDA CFR.
- Work closely with the Research Institute and Human Research Protection Program and have a working knowledge of KUMC policies and procedures.
- Attend continuing education, research and training seminars as requested by manager.
- Perform other duties as assigned.
Required Documents: Must provide both:
- Cover letter & Resume
Employee Type:
Regular
Time Type:
Full time
Pay Rate Type:
Salary
Pay Grade:
A11
Pay Range:
Minimum
51348Midpoint
65352Maximum
79356Department:
SOM KC Cancer Center Clinical Trials
-----
Clinical Trials Clinical OperationsPosition Title:
Clinical Research Coordinator Community Site Float
Job Family Group:
Professional Staff
Job Description Summary:
This position is responsible for working collaboratively with multidisciplinary teams, research and hospital staff to recruit, screen, educate, and assist in the overall clinical study coordination of clinical research. The Clinical Research Coordinator will manage clinical research studies by coordinating and participating in a variety of complex activities involved in the collection, compilation, documentation and analysis of clinical research data. Monitor participants’ progress including documenting and reporting adverse events. Participate in periodic quality assurance audits of protocols.
Job Description:
The Clinical Research Coordinator (CRC) is responsible for working collaboratively with multidisciplinary teams, research and hospital staff to recruit, screen, educate, and assist in the overall clinical study coordination of clinical research. The CRC will manage The University of Kansas Cancer Center clinical research studies by coordinating and participating in a variety of complex activities involved in the collection, compilation, documentation and analysis of clinical research data. Monitor participants’ progress including documenting and reporting adverse events. Participate in periodic quality assurance audits of protocols.
Individual filling this role will spend 2 days at our North Community Site - 8700 North Green Hills Rd., and 2 days at our Lee's Summit Community Site - 4881 NE Goodview Circle, Lee's Summit. The other day will at either clinic based on need.
The University of Kansas Cancer Center is the region's only National Cancer Institute-designated cancer center where patients gain access to the most promising therapies, cutting-edge clinical trials and world class research.
Join our clinical trials team where you can make a difference!
The starting salary is between the minimum and midpoint of the salary range listed.
Required Qualifications:
- Education: Associate’s degree plus two years related work experience OR an equivalent combination of relevant post secondary education and work experience that equals at least 4 years.
- Experience: Minimum of one year experience as a clinical research coordinator or two years healthcare experience with patient interaction or related experience. Basic understanding of regulations governing clinical research (CFR, GCP, HIPAA). Solid understanding of statutes and guidelines relevant to regulatory affairs in clinical research. Knowledgeable of study budgets, contracts and grant applications.
- Skills: Excellent communication, writing, organizational and presentation skills. Ability to effectively interact with multidisciplinary teams including physicians, administrative staff. Ability to recognize competing priorities and deadlines and seek guidance in management of these where needed. Willingness to seek research certifications to further skills in the position.
Preferred Qualifications:
- Research certification preferred such as Socra certification or certification eligible: Certified Clinical Research Coordinator (CCRC) or certification eligible, Certified Clinical Research Professional (CCRP) or certification eligible Collaborative Institutional Training Initiative (CITI) training certification or certification eligible.
- Skills: Ability to read, speak and write Spanish preferred.
Job Duties Outlined:
- Under the direction of the principal investigator, recruit and educate potential patients for and evaluate potential patient eligibility for clinical trials.
- Maintain source documents and submit case report forms (CRFs) as required for clinical trials.
- Recognize and report adverse events/serious adverse events to the Principal Investigator, FDA, and sponsors.
- Perform study procedures, as outlined in the protocol and within state and institutional scope of practice.
- Assist clinical staff with sample collection, processing, handling, and shipping as outlined in the protocol and within institutional/KUMC policy.
- Ensure adequate study supplies are being maintained. Track study expenditures and submit reimbursement requests for study equipment, supplies and study participants.
- Prepare documentation and participate in study monitoring visits, reviews and audits. Provide written and verbal reports to Principal Investigator and Project Manager, as required.
- Participate in quality assurance activities by reviewing clinical data in medical record charts, assessing pharmacy compliance with protocol criteria and reviewing study documentation to ensure compliance with GCP guidelines and FDA CFR.
- Work closely with the Research Institute and Human Research Protection Program and have a working knowledge of KUMC policies and procedures.
- Attend continuing education, research and training seminars as requested by manager.
- Perform other duties as assigned.
Required Documents: Must provide both:
- Cover letter & Resume
Employee Type:
Regular
Time Type:
Full time
Pay Rate Type:
Salary
Pay Grade:
A11
Pay Range:
Minimum
51348Midpoint
65352Maximum
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