Department:

SOM KC Internal Medicine - Pulmonary, Critical Care, and Sleep Medicine

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Pulmonary and Critical Care Medicine

Position Title:

Senior Clinical Research Coordinator - Internal Medicine (Pulmonary)

Job Family Group:

Professional Staff

Job Description Summary:

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.

*** This role is required to be on campus due to the nature of the work***

Compensation to commensurate with experience.

Job Description:

Required Qualifications:

Education/Certifications:

• Associate’s degree or an equivalent combination of relevant post-secondary education and work experience that equals at least 2 years

• At least one of the following certifications:

  • Certified Clinical Research Coordinator(CCRC)

  • Certified Clinical Research Professional(CCRP)

Work Experience:

• 4 years related work experience

• Advanced understanding of regulations governing clinical research (CFR, GCP, HIPAA).

• Experience with study budgets, contracts and grant applications.

• Advanced understanding of statutes and guidelines relevant to regulatory affairs in clinical research as evidenced by application materials

Preferred Qualifications

Education:

• Master’s degree in relevant field.

Skill:

• Business and financial acumen to assist in developing study budgets, contracts, and grant applications.

• Ability to fully contribute to multidisciplinary teams including physicians, and administrative staff.

• Ability to effectively manage competing priorities and deadlines.

Job Duties

• 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 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

• Assure that all professional nursing care provided is conducted in accordance with all KUMC and other regulatory requirements and is in accordance with the scope of practice for the nursing license held

• Other relevant duties as requested by the supervisor.

Required Documents

• Resume

• Cover letter showing how you meet the required and preferred qualifications. 

• 3 professional references 

Comprehensive Benefits Package:

Employee Type:

Regular

Time Type:

Full time

Rate Type:

Salary

Compensation Statement:

The pay range listed for this position is determined by our compensation program using market data and salary benchmarking. A combination of factors is considered in making compensation decisions including, but not limited to, education, experience and training, qualifications relative to the requirements of the position, and funding. At the University of Kansas Medical Center, a reasonable estimate for the starting pay range will be the minimum to midpoint of the posted range, taking into account the combination of factors listed above. 

Pay Range:

$65,000.00 - $99,000.00

Minimum

$65,000.00

Midpoint

$82,000.00

Maximum

$99,000.00