Senior Clinical Research Coordinator Community Site Float

Department:
SOM KC Cancer Center Clinical Trials

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Clinical Trials Clinical Operations
Position Title:
Senior 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 Senior Clinical Research Coordinator will manage clinical research studies by coordinating and overseeing a variety of complex activities involved in the collection, compilation, documentation and analysis of clinical research data. Participate in periodic quality assurance audits of protocols. Assist with study budgets and contracts and assist with grant applications.
Job Description:
The Senior Clinical Research Coordinator works collaboratively with multidisciplinary teams, research, and hospital staff to recruit, screen, educate, and assist in the overall clinical study coordination of clinical research. The Senior Clinical Research Coordinator will manage assigned clinical research studies by supervising a variety of complex activities involved in the collection, compilation, documentation, and analysis of clinical research data. Participates in periodic quality assurance audits of protocols. Supports the development of study budgets, contracts, and grant applications. Provides task direction, as needed, for junior level clinical research coordinators.

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. We strive to provide the most advanced comprehensive care possible. In addition to standard care and treatments, we perform studies to help find better ways of preventing, diagnosing and treating various types of cancer.
Join our clinical trials team where you can make a difference!

Required Qualifications:

• Education: Associate’s degree plus six years related work experience OR an equivalent combination of relevant post secondary education and work experience that equals at least 8 years. 
• Skills: Basic understanding of regulations governing clinical research (CFR, GCP, HIPAA). Solid understanding of statutes and guidelines  relevant to regulatory affairs in clinical research. Excellent communication, writing, organizational and presentation skills. Ability to fully contribute to multidisciplinary teams including physicians, administrative staff. Ability to effectively manage competing priorities and deadlines. Knowledgeable of study budgets, contracts and grant applications.

Preferred Qualifications:

• Skills: 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. Ability to read, speak and write Spanish preferred.

Job Duties Outlined:

• Under the direction of the principal investigator, recruit, educate potential patients for and evaluate potential patient eligibility for clinical trials. 
• Assist clinical staff with maintaining 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.
• Assist clinical staff with study procedures, as outlined in the protocol and within state and KUMC scope of practice. 
• As requested, facilitate monitoring visits, reviews and audits.  Provide written and verbal reports to Principal Investigator and Project Manager, as required.
• Prepare and maintain clinical trial contract documents and study budget reports.
• 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 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.
• Attend continuing education, research and training seminars as requested by manager.
• 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. 
• Coordinate closely with the Research Institute and Human Research Protection Program and have a significant working knowledge of KUMC policies and procedures. 
• Reviews and assists with editing of new protocols.  Assesses feasibility of research protocol including appropriate patient population, budget and specific needs for the study.
• Assist Principal Investigators with internal and external funding application submissions
• Other relevant duties as requested by the supervisor.

Required Documents:

• Resume/CV & Cover Letter

Employee Type:
Regular
Time Type:
Full time
Pay Rate Type:
Salary
Pay Grade:
A12
Pay Range:

Minimum

57572

Midpoint

73650

Maximum

89210

Department:
SOM KC Cancer Center Clinical Trials

-----

Clinical Trials Clinical Operations
Position Title:
Senior 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 Senior Clinical Research Coordinator will manage clinical research studies by coordinating and overseeing a variety of complex activities involved in the collection, compilation, documentation and analysis of clinical research data. Participate in periodic quality assurance audits of protocols. Assist with study budgets and contracts and assist with grant applications.
Job Description:
The Senior Clinical Research Coordinator works collaboratively with multidisciplinary teams, research, and hospital staff to recruit, screen, educate, and assist in the overall clinical study coordination of clinical research. The Senior Clinical Research Coordinator will manage assigned clinical research studies by supervising a variety of complex activities involved in the collection, compilation, documentation, and analysis of clinical research data. Participates in periodic quality assurance audits of protocols. Supports the development of study budgets, contracts, and grant applications. Provides task direction, as needed, for junior level clinical research coordinators.

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. We strive to provide the most advanced comprehensive care possible. In addition to standard care and treatments, we perform studies to help find better ways of preventing, diagnosing and treating various types of cancer.
Join our clinical trials team where you can make a difference!

Required Qualifications:

• Education: Associate’s degree plus six years related work experience OR an equivalent combination of relevant post secondary education and work experience that equals at least 8 years. 
• Skills: Basic understanding of regulations governing clinical research (CFR, GCP, HIPAA). Solid understanding of statutes and guidelines  relevant to regulatory affairs in clinical research. Excellent communication, writing, organizational and presentation skills. Ability to fully contribute to multidisciplinary teams including physicians, administrative staff. Ability to effectively manage competing priorities and deadlines. Knowledgeable of study budgets, contracts and grant applications.

Preferred Qualifications:

• Skills: 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. Ability to read, speak and write Spanish preferred.

Job Duties Outlined:

• Under the direction of the principal investigator, recruit, educate potential patients for and evaluate potential patient eligibility for clinical trials. 
• Assist clinical staff with maintaining 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.
• Assist clinical staff with study procedures, as outlined in the protocol and within state and KUMC scope of practice. 
• As requested, facilitate monitoring visits, reviews and audits.  Provide written and verbal reports to Principal Investigator and Project Manager, as required.
• Prepare and maintain clinical trial contract documents and study budget reports.
• 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 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.
• Attend continuing education, research and training seminars as requested by manager.
• 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. 
• Coordinate closely with the Research Institute and Human Research Protection Program and have a significant working knowledge of KUMC policies and procedures. 
• Reviews and assists with editing of new protocols.  Assesses feasibility of research protocol including appropriate patient population, budget and specific needs for the study.
• Assist Principal Investigators with internal and external funding application submissions
• Other relevant duties as requested by the supervisor.

Required Documents:

• Resume/CV & Cover Letter

Employee Type:
Regular
Time Type:
Full time
Pay Rate Type:
Salary
Pay Grade:
A12
Pay Range:

Minimum

57572

Midpoint

73650

Maximum

89210