Johnson County Clin Trials (JCCT) · 2 months ago
Clinical Study Coordinator-JCCT
Lenexa, KS
Full-time
Onsite
Mid Level
3+ years expJohnson County Clin Trials (JCCT) is a recognized clinical research site in the United States, seeking a Clinical Study Coordinator to manage clinical studies. The role involves coordinating research procedures, maintaining study records, and ensuring compliance with protocols under the direction of the Study Management team.
BiotechnologyClinical TrialsConsultingLife ScienceMedicalTherapeutics
Responsibilities
Maintain required records of study activity including study logs, case report forms, and/or regulatory forms
Schedule volunteers for appointments, procedures and inpatient stays as required by study protocols
Assess eligibility of potential volunteers through methods such as subject interviews, reviews of medical records, and discussions with Investigators and Research Associates
Communicate with the Laboratory and/or Investigators regarding Lab procedures and/or findings
Educate study volunteers on study procedures such as diary completion, electronic devices and expected outcomes in a profession and accountable manner following protocol requirements
Responsible for assuring training and documentation is completed for protocol amendments, ICFs, updated guidelines, etc
Communicate with Nursing staff on an ongoing basis regarding study updates, amendments/ changes
Communicate with Investigators on an ongoing basis regarding study progress, safety issues and other important information
Maintain contact with sponsors/CROs and respond in a timely manner as well as schedule/ coordinate site visits
Professional communication and collaborative work ethic with CRAs at Site visits
Order and track supplies or devices necessary for study completion
Prepare study-related source documentation according to protocol and system guidelines and work with QA department collaboratively to make appropriate changes
Record adverse events and discuss with Investigators regarding the reporting of events to oversight agencies
Track enrollment status of volunteers and documentation in Clinical Conductor system
Perform specific protocol procedures such as interviewing volunteers, taking vital signs, and performing electrocardiograms, etc
Prepare for or participate in quality assurance audits conducted by sponsors, federal agencies or specially designated review groups
Adherent to safety and privacy regulations
Other duties as assigned
Qualification
Required
High school diploma or GED
Basic understanding of regulations governing clinical research (CFR, GCP, HIPAA)
Solid understanding of statutes and guidelines relevant to regulatory affairs in clinical research
Excellent communication, interpersonal, analytical and problem-solving skills
Microsoft Office Suite proficiency
Writing and verbal communication skills
Strong study documentation skills in compliance with ALCOA+
Familiarity with electronic case report form systems such as Medidata Rave, Inform, TrialKit, etc
Ability to work effectively with a team
Ability to manage small projects personally and work independently
Ability to prioritize and manage multiple projects simultaneously
Memory to retain information and know where to research answers
Time management skills
Organizational skills
Detail oriented with the ability to perform at a high level of accuracy
Demonstrates strong critical thinking, problem solving skills
Self-motivated
Must be results oriented, multi-tasking, quick learner
Respond to the urgent needs of the team and show a strong track record of meeting deadlines
Ability to sit, stand, walk, reach with hands and arms, and use hands along with fingers, to handle or feel
Ability to lift and/or move up to 20 pounds
Preferred
Bachelor's degree in Science
3 to 5 years of experience in a clinical research setting or related work environment
Familiarity with or ability to learn clinical trial management system software
Company
Johnson County Clin Trials (JCCT)
Johnson County Clin-Trials (JCCT) has been providing clinical research services to small biotech’s and large multi-national CRO’s and Pharma since 2005.
51-200 employees
Funding
Current Stage
Growth StageTotal Funding
unknownKey Investors
Friedman Fleischer & Lowe (FFL)
2023-08-28Private Equity
Leadership Team
Nathan Arthur
Chief Executive Officer
Recent News
Morningstar.com
2025-06-12
2025-04-09
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