- Experience with regulations governing clinical research (CFR, GCP, HIPAA).
- Experience with statutes and guidelines relevant to regulatory affairs in clinical research.
- Experience study budgets, contracts, and grant applications.
- Excellent communication as evidenced in application materials.
- Willingness to seek research certifications to further skills in the position.
- Research certification preferred such as Socra certification or certification eligible: Certified Clinical Research Coordinator (CCRC) or certification eligible, Certified Clinical Research Professional (CCRP) or certification eligible Collaborative Institutional Training Initiative (CITI) training certification or certification eligible.
- Excellent writing, organizational and presentation skills.
- Effectively interact with multidisciplinary teams including physicians, administrative staff.
- Experience recognizing competing priorities and deadlines and seek guidance in management of these where needed.
- Under the direction of the principal investigator, recruit and educate potential patients for and evaluate potential patient eligibility for clinical trials.
- 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 clinical staff with phlebotomy and sample collection, processing, handling, and shipping as outlined in the protocol and within institutional/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.
- 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 Institute and Human Research Protection Program and have a working knowledge of KUMC policies and procedures.
- Attend continuing education, research and training seminars as requested by manager.
- Perform other duties as assigned.
- Resume/CV
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Clinical Research Coordinator - Kansas City, United States - University of Kansas Medical Center
Description
Department:
SOM KC Cancer Center Clinical Trials
* -Clinical Research
Position Title:
Clinical Research Coordinator - Cancer Center (Hem/CT)
Job Family Group:
Professional Staff
Job Description Summary:
The 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.
This position manages clinical research studies by coordinating and participating in a variety of complex activities involved in the collection, compilation, documentation and analysis of clinical research data.
Monitors participants' progress including documenting and reporting adverse events. Participates in periodic quality assurance audits of protocols.Job Description:
This position will be 100% onsite due to the fact this is a patient facing role.
This clinical research is dedicated to the treatment of hematologic malignancies through cellular therapies such as hematopoietic stem cell transplantation (HCT).
The research focuses on strategies to reduce complications of HCT and ranges from preclinical studies using murine models of HCT to Phase 1 and Phase 2 clinical trials.
Areas of interest include the role of the microbiota, nutrition, and exercise in modulating HCT outcomes such as graft-versus-host disease (GVHD) and infections.
The University of Kansas Cancer Center is the only National Cancer Institute designated Comprehensive Cancer Center in the region, 1 of only 57 in the nation to receive this distinction.
Required Qualifications
Education:
Associate's degree plus two years related work experience OR an equivalent combination of relevant post secondary education and work experience that equals at least 4 years.
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.
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:
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:
$58, $86,000.00
Minimum
$58,000.00
Midpoint
$72,000.00
Maximum
$86,000.00