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This job was posted by https://www.kansasworks.com : For more information, please see: https://www.kansasworks.com/jobs/13133336

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rSenior Clinical Research Coordinator Internal Medicine (Nephrology)

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Department:

SOM KC Internal Medicine - Nephrology and Hypertension

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Medicine - Nephrology and Hypertension

Position Title:

Senior Clinical Research Coordinator - Internal Medicine (Nephrology)

Job Family Group:

Professional Staff

Job Description Summary:

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.

Job Description:

Job Duties:

• Under the direction of the principal investigator, recruit, educate potential patients for and evaluate potential patient eligibility for clinical trials.
• Transplant patients can be admitted at any time day or night. This position may require work over the weekend, nights, or holidays, depending on enrollment and transplant schedule. Coordinators will take a rotating call schedule for coverage.
• 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 phlebotomy and 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.
• This job description is not designed to cover or contain a comprehensive listing of activities, dutie or responsibilities that are required of the employee for this job. It is only a summary of the typical functions of the job, not an exhaustive list of all possible job responsibilities, tasks, duties, and assignments. Furthermore, job duties, responsibilities and activities may change at any time with or without notice.

Required Qualifications

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

Certifications: Research certification (CCRC or CCRP)

Work Experience:

• 4 years related work 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 study budgets, contracts, and grant applications.

Preferred Qualifications

Education: Master\'s degree in relevant field.

Work Experience: Business and financial acumen to assist in developing study budgets, contracts, and grant applications.

Skills

Excellent communication, writing, organizational and presentation skills.

Ability to fully contribute to multidisciplinary te