SOM KC Internal Medicine - Administration
Sr. Clinical Research Coordinator
Job Family Group:
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.
We seek to advance the power of medicine by providing a stimulating, supportive climate where faculty, scientists, trainees and support staff strive for excellence and collaborate freely to achieve shared goals. In order to accomplish this, we focus on five major principles:
Save the patient.
Ultimately, we all work in medicine, whether through patient care, education, or research to help save our patients. It is, at once, both our calling and our greatest challenge.
Do the right thing.
In caring for our patients and in pursuing research and teaching, we must act in a way that conveys our spirit of cooperation and our dedication to reason. We must do the right thing to serve as an example to our colleagues around us and especially to our patients and to our learners.
Be the bridge.
Separating ourselves from our colleagues who have dedicated themselves to patient care only, in an academic medical center we must constantly be striving to seek answers to questions that are yet unanswered. Our curiosity helps define this difference and it is our quest to respond to this curiosity that makes academic medicine our career.
Ask questions, seek answers.
In our department, we emphasize that we are here to build bridges and not silos. Our spirit of collegiality and collaboration as opposed to confrontation is critical to our success. By building bridges to the various research sciences and institutes in our university and in our community, we make ourselves stronger.
Those who laugh, last.
Finally, as is emphasized to the residents and our other learners almost every day, you have to love what you do and you have to do what you love. If you do those things, then it makes your job more than a job. Our department works hard, and we are proud of our people and our accomplishments. And while we work hard, we also have fun. It is this spirit that helps build a positive environment in which we define success not only in what we accomplish individually but how far we go as a team.
COMPREHENSIVE BENEFITS PACKAGE:
Health, dental, vision, employer paid life, LTD, flexible benefits plan, miscellaneous voluntary plans available, paid vacation and sick (begin accruing upon hire), paid holidays, paid discretionary day, paid bereavement leave, paid jury duty leave, military leave, paid parental leave, retirement plan.
Anticipated salary is $65k-$72k, commensurate with experience.
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.
Associate's degree plus six years related work experience OR an equivalent combination of relevant post-secondary education and work experience that equals at least 8 years.
Skills & Competencies:
Advanced understanding of regulations governing clinical research (CFR, GCP, HIPAA).
Advanced understanding of statutes and guidelines relevant to regulatory affairs in clinical research.
In-depth knowledge of study budgets, contracts and grant applications.
Ability to fully contribute to multidisciplinary teams including physicians, administrative staff.
Ability to effectively manage competing priorities and deadlines.
Required Research certification such as:
Research certification required such as:
Certified Clinical Research Coordinator(CCRC) or certification eligible
Certified Clinical Research Professional(CCRP) or certification eligible
Business and financial acumen to assist in developing study budgets, contracts and grant applications.
Master's degree in relevant field.
A complete application includes:
2. Cover letter showing how you meet the required and preferred qualifications.
3. 3 professional references
- This is a rolling Evergreen posting that continually accepts applications for numerous open positions within Internal Medicine.
$60,000.00 - $93,000.00
To learn more and apply online, please visit https://kumc.wd5.myworkdayjobs.com/en-US/kumc-jobs/job/Kansas-City-Metro-Area/Sr-Clinical-Research-Coordinator_JR000956 or go to https://careers.kumc.edu/ and search for position number JR000956.
Applications must be submitted directly through the KU Medical Center website to be considered for this position. Any applications submitted via email or this website will NOT be reviewed or considered.
About KU Medical Center:
The University of Kansas Medical Centers mission is to educate exceptional health care professionals through a full range of undergraduate, graduate, professional, postdoctoral and continuing education programs in the schools of Medicine, Nursing and Health Professions. KU Medical Center also advances the health sciences through world-class research programs; provides compassionate and state-of-the-art patient care in an academic medical center environment; and works with communities in every Kansas county to improve the health of Kansans. Learn more at www.kumc.edu .
KUMC offers a range of great benefits that support employees and eligible family members. Our health insurance benefits begin on hire date and KUMC offers other exciting benefits such as paid parental leave, generous employer retirement contributions and other resources to improve health and well-being. For more information, please visit https://www.kumc.edu/human-resources/benefits.html