Clinical Research Coordinator- Cardiology

University of Kansas Medical Center; United States; On-site; USD 61,000 - 91,000; Full time

Benefits offered by this job

Health insurance

Retirement plan

Paid time off

Job summary

University of Kansas Medical Center is seeking a Clinical Research Coordinator in Cardiology to coordinate complex clinical studies and ensure regulatory compliance. The role involves enrolling participants, managing CRFs, and collaborating with investigators and staff across departments.

Responsibilities include running study procedures, monitoring data quality, budgeting support, and mentoring Clinical Research Assistants within the Cardiovascular Research program.

Qualifications

• Six years of work experience in healthcare or research setting.
• Experience with clinical research regulations (FDA, GCP, IRB, HIPAA).
• Experience with study budgets, contracts and/or grant applications.

Responsibilities

• Under PI direction, recruit and educate potential patients for clinical trials.
• Develop and maintain source documents and submit CRFs for trials.
• Recognize and report adverse events to PI, FDA, and sponsors.
• Perform study procedures per protocol and scope of practice.
• Assist with sample collection, processing, and shipping per protocol and policy.
• Track and document study visits in the trial management system and assist with reimbursements.

Skills

Communication

Computing

Self-initiative

Organization

Detail orientation

Time management

Prioritization

Delegation

Education

Bachelor’s degree in health sciences, biology, nursing, or related field

Job description

Department

SOM KC Division of Cardiovascular Diseases

Position Title

Clinical Research Coordinator- Cardiology

Job Family Group

Professional Staff

Job Description Summary

The Clinical Research Coordinator in the department of Cardiology works collaboratively with multidisciplinary teams, research, and hospital staff in the overall clinical study coordination of clinical research.

This position coordinates assigned clinical research studies across a variety of complex activities involved in the collection, compilation, documentation, and analysis of clinical research data.

Supports regulatory and study compliance.

Job Responsibilities

• Under the direction of the principal investigator, recruit and educate potential patients for and evaluate potential patient eligibility for clinical trials.
• Develop and 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 with sample collection, processing, handling, and shipping as outlined in the protocol, department expectations, and within institutional/KUMC policy.
• Ensure adequate study supplies are being maintained.
• Track and document study visits in the Clinical Trials Management System, study expenditures and submit reimbursement requests for study equipment, supplies and study participants.
• Maintain trial regulatory documentation files as directed, including correspondence with sponsor, IRB, departmental support and participants.
• Prepare documentation and participate in study monitoring visits, reviews and audits.
• Provide written and verbal reports to Principal Investigator and other team members, 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 Administration, Department Administrators and Human Research Protection Program and have a working knowledge of KUMC policies and procedures.
• Participate in continuing education, research and training.
• Coordinate study participant visit activities including scheduling procedures, communicating with participants.
• Assist feasibility assessment of research protocol including appropriate patient population, budget and specific needs for the study.
• Report out study budgets, contracts, and grant applications throughout the Lifecyle of the study.
• Support the development of study budgets, contracts grant applications and study documents for start-up and throughout the lifecycle of the study.
• This role will mentor Clinical Research Assistants.

This job description is not designed to cover or contain a comprehensive listing of activities, duties 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

• Work Experience: Six years of work experience in healthcare or research setting.
• Experience with clinical research regulations (FDA, GCP, IRB, HIPAA).
• Experience with study budgets, contracts and/or grant applications.

Preferred Qualifications

• Education: Bachelor’s degree in relevant field like health sciences, biology, nursing, or a related field.
• Experience may be substituted for education on a year for year basis.
• Certifications: Certified Clinical Research Coordinator (CCRC) or Certified Clinical Research Professional (CCRP) or Association of Clinical Research Professionals (ACRP).

Skills

• Communication skills.
• Computer skills.
• Self-initiative.
• Organization.
• Detail-Oriented.
• Time management.
• Prioritization.
• Delegation.

Required Documents

Resume Cover Letter

Comprehensive Benefits Package

• Coverage begins on day one for health, dental, and vision insurance and includes health expense accounts with generous employer contributions if the employee participates in a qualifying health plan.
• Employer-paid life insurance, long-term disability insurance, and various additional voluntary insurance plans are available.
• Paid time off, including vacation and sick, begins accruing upon hire, plus ten paid holidays.
• One paid discretionary day is available after six months of employment, and paid time off for bereavement, jury duty, military service, and parental leave is available after 12 months of employment.
• A retirement program with a generous employer contribution and additional voluntary retirement programs (457 or 403b) are available.
• https://www.kumc.edu/human-resources/benefits.html

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: $60,800.00 - $91,200.00 Minimum $60,800.00 Midpoint $76,000.00 Maximum $91,200.00

Mission

The mission of the University of Kansas Medical Center is to improve lives and communities in Kansas and beyond through innovation in education, research, and health care.

Equal Opportunity/Affirmative Action

The University of Kansas Medical Center is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, national origin, ethnicity, ancestry, age, protected veteran or disability status, marital status, parental status, or genetic information.

http://policy.ku.edu/IOA/nondiscrimination

https://kumc-publicpoliciesandprocedures.policystat.com/policy/8446235/latest/

Disability Preference under Kansas State Law

Under Kansas state law, certain KUMC positions are subject to disability preference. For positions subject to this requirement, KUMC will offer an interview to a person who has applied for an open position who is qualified, with or without reasonable accommodation, to meet the performance standards of the position and who has presented acceptable proof of disability. If the position you apply for is subject to the disability preference requirement, you will be asked to provide information in support of your request for disability preference when you complete the application for employment.

https://civilrights.ku.edu/annual-security-and-fire-safety-report

https://www.e-verify.gov/sites/default/files/everify/posters/EVerifyParticipationPoster.pdf

https://www.laborposters.org/federal/1606-federal-pay-transparency-poster.htm