- Prior CRC/Regulatory experience.
- Experience in health behavioral education is desirable.
- Excellent communication, writing, organization, presentation skills.
- Attention to detail, proficient with time management challenges, ability to effectively interact with multidisciplinary teams including physicians, administrative staff.
- Ability to recognize 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.
- Other relevant duties as requested by the supervisor.
- Resume/CV
- Cover Letter
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Clinical Research Coordinator - Kansas City, United States - University of Kansas Medical Center
Description
Department:
SOM KC Psychiatry & Behavior Sciences
* -Administration
Position Title:
Clinical Research Coordinator - Psychiatry
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 assigned clinical research studies by supervising 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:
Required Qualifications
Education:
Associate's degree plus two years required work experience OR an equivalent combination of relevant post-secondary education and work experience that equals 4 years.
A combination of education and relevant experience may substitute for a degree on a year for year basisWork Experience:
Basic understanding of regulations governing clinical research (CFR, GCP, HIPAA), basic understanding of statutes and guidelines relevant to regulatory affairs in clinical research and knowledgeable of study budgets, contracts and grant applications.
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
