Clinical Research Coordinator II

Responsibilities

Develop strong working relationships and become the point of contact for the clinic as well as the sponsor for clinic related activities

Manage multiple concurrent trials

Assist with mentoring and training study team members

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 (if applicable) 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 ethics 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

Collect, process and ship laboratory specimens

Adherent to safety and privacy regulations

Preferred

Strong study documentation skills in compliance with ALCOA+

Familiarity with electronic case report form systems such as Medidata Rave, Inform, TrialKit, etc

Previous nursing, medical assistant experience in a clinical setting a plus

CCRC certification a plus

Benefits

Support, acceptance, and respect as an individual in a family focused environment

A positive work environment

The opportunity for personal growth and satisfaction

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.

Lenexa, Kansas, USA

https://jcct.com/

Growth Stage

Total Funding

unknown

Key Investors

Friedman Fleischer & Lowe (FFL)

2023-08-28

Private Equity

Leadership Team

Nathan Arthur

Chief Executive Officer

Recent News

Morningstar.com

JCCT Appoints New CEO to Accelerate Growth and Innovation

2025-06-12

FFL Partners

news FFL Partners Completes Growth Investment in Johnson County Clin-Trials

2025-04-09

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Qualifications

The position requires sound judgment and a high-level knowledge of study specific protocols

The primary skills include logical thinking, ability to prioritize, “can-do” attitude, the ability to adapt quickly to changing business conditions, strong interpersonal and team building skills

BS/BA in Life Science or related discipline or equivalent work experience

Basic understanding of regulations governing clinical research (CFR, GCP, HIPAA)

Minimum 3 years of experience coordinating clinical trials, including the activities listed above

Demonstrated relationship building, with strong verbal and written skills

Ability to successfully coordinate protocols with overlapping timelines

Ability to explain importance of GCP guidelines and their application

Ability to train others on coordinating responsibilities and protocol adherence

Able to follow clinical research participant safety requirements including ICF process, role of the IRB and adverse event reporting

Strong interpersonal skills with attention to detail a must

Proven ethical and professional codes of conduct

Demonstrated proficiency with word processing, spreadsheet, database, and presentation software (MS Office skills such as Outlook, Word, Excel, PowerPoint, SharePoint) and with regulatory filing systems

Excellent communication, interpersonal, analytical and problem-solving skills

Microsoft Office Suite proficiency

Proficiency in Spanish and English, including the ability to speak, read, and write in both languages

Writing and verbal communication skills

Ability to work effectively with a team

Ability to prioritize and manage multiple projects simultaneously

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

Strong study documentation skills in compliance with ALCOA+

Familiarity with electronic case report form systems such as Medidata Rave, Inform, TrialKit, etc

Previous nursing, medical assistant experience in a clinical setting a plus

CCRC certification a plus

Required skills

Clinical Trial Coordination, Clinical Practice (GCP), Code of Federal Regulations (CFR), HIPAA, Clinical Research Coordinator Certification (CCRC), Microsoft Office, Medidata Rave, Inform, TrialKit, ALCOA+ Documentation

Preferred skills

Strong study documentation skills in compliance with ALCOA+, CCRC certification a plus

Experience

3+ years