- Bachelor's degree OR an equivalent combination of relevant post-secondary education and work experience that equals at least 4 years .
- Must have research certification such as Certified Clinical Research Coordinator (CCRC), Certified Clinical Research Professional (CCRP) or other related research certification.
- Demonstrated advanced understanding of regulations governing clinical research (CFR, GCP, HIPAA).
- Demonstrated advanced understanding of statutes and guidelines relevant to regulatory affairs in clinical research.
- In-depth knowledge of study budgets, contracts, and grant applications.
- Excellent communication as evidenced by application materials.
- Experience using computer MSO Suite: Outlook, Windows, Excel and Word.
- Business and financial acumen to assist in developing study budgets, contracts and grant applications.
- Ability to fully contribute to multidisciplinary teams including physicians, administrative staff
- Demonstrated ability to work independently.
- Superb attention to detail, organizational, and time management skills as evidenced by application materials.
- 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.
- This position is responsible for lead worker duties including mentoring, training and assisting junior staff with onboarding and learning the clinical research coordinator position.
- 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.
- Review and assist 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.
- Resume/CV
- Cover Letter
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Senior Clinical Research Coordinator- Cancer Center - Kansas City, United States - University of Kansas Medical Center
Description
Description
:Condition of employment:
Must maintain research certification during employment, such as Certified Clinical Research Coordinator (CCRC), Certified Clinical Research Professional (CCRP) or other related certification.
Required Qualifications
Education:
Work Experience: 4 years clinical research experience that includes the following.
Preferred Qualifications
Education: Master's degree in relevant field.
Work Experience:
Skills:
Job Duties Outlined:
Required Documents:
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 nine 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.
Employee Type:
RegularTime Type:
Full timeRate Type:
SalaryCompensation 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, $99,000.00Minimum
$65,000.00Midpoint
$82,000.00Maximum
$99,000.00
