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University of Kansas Medical Center Senior Clinical Research Coordinator - Masonic Cancer Alliance in Kansas City, Kansas

This job was posted by https://www.kansasworks.com : For more information, please see: https://www.kansasworks.com/jobs/12837071

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Department:

SOM KC Cancer Center Administration

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Masonic Cancer Alliance

Position Title:

Senior Clinical Research Coordinator - Masonic Cancer Alliance

Job Family Group:

Professional Staff

Job Description Summary:

Job Description:

The Senior Clinical Research Coordinator works collaboratively with Masonic Cancer Alliance (MCA) member sites and 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 contracts, and grant applications. Provides task direction, as needed, for junior level clinical research coordinators.

The University of Kansas Cancer Center is the region\'s only National Cancer Institute-designated comprehensive 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.

Condition of Employment

  • Research certification required such as Socra, Certified Clinical Research Coordinator (CCRC), or Certified Clinical Research Professional (CCRP).

Required Qualifications:

Education: Bachelor\'s degree OR and equivalent combination of relevant post-secondary education and work experience that equals at least 4 years.

Work Experience:

  • 4 years clinical research experience.
  • Advanced understanding of regulations governing clinical research (CFR, GCP, HIPAA).
  • Advanced understanding of statutes and guidelines relevant to regulatory affairs in clinical research.
  • In-depth knowledge of contracts and grant applications.

Preferred Qualifications

Education: Master\'s degree in relevant field.

Work Experience: Experience in business and financial acumen to assist in developing, contracts and grant applications.

Skills:

  • 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.

Job Duties Outlined

  • Under the direction of the KUCC-MCA MU NCORP principal investigator evaluate potential patient eligibility for clinical trials.
  • Assist MCA clinical staff with maintaining source documents and submit electronic case report forms (CRFs) as required for clinical trials.
  • This position is responsible for lead worker duties including mentoring, training and assisting MCA staff with onboarding and assure completion of KU requirements for investigators and site staff.
  • Recognize and report adverse events/serious adverse events to the Principal Investigator, FDA, and sponsors.
  • Assist clinical staff with understanding study procedures, as outlined in the protocol, reporting protocol deviations and developing corrective and preventive plans as needed.
  • Prepare documents for distribution to MCA sites regarding eligibility and training for new trials.
  • As requested, facilitate monitoring visits, reviews and audits. Provide written and verbal reports to Principal Investigator and Project Manager, as required.
  • Assist clinical staff with sample collection, processing, handling, and shipping as outlined in the protocol.
  • Ensure adequate study supplies are being maintained.
  • Prepare documentation and participate in study monitoring visits, reviews and audits. Provide written and verbal reports to Principal Investigator and Project Manager, as required.

{=html} <!-- --> - Attend continuing education, research and training seminars as requested by manager, including KUCC disease working group meetings and national NCTN meetings. - 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. - Assesses feasibility of research protocol including appropriate patient population, budget and specific needs for the study if inclusion of MCA sites. - Assist Principal Investigators with internal and external funding application submissions. - A minimum of 20% travel. - Other relevant duties as requested by the supervisor.

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