Clinical Research Coordinator II

Johnson County Clintrials LLC•North Kansas City, MO

About The Position

The purpose of the Clinical Research Coordinator II role is to ensure the successful execution of multiple concurrent clinical trials through effective study coordination, subject management, and cross-functional communication. This position serves as a primary liaison between investigators, study teams, sponsors, and clinical staff to maintain protocol compliance, uphold regulatory and documentation standards, and support the integrity and quality of clinical research activities. By applying advanced knowledge of study protocols, strong organizational skills, and sound judgment, the Clinical Research Coordinator II contributes to the timely, efficient, and high-quality conduct of clinical studies that advance research objectives and improve patient outcomes. The Clinical Research Coordinator II is responsible for the coordination and administration of overlapping clinical studies. Serves as the main point of contact for sponsors for assigned trials. The Study Coordinator will perform diverse administrative duties requiring analysis. 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. This position reports to the Site Manager or Site Director.

Requirements

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
Writing and verbal communication skills
Strong study documentation skills in compliance with ALCOA+ preferred
Familiarity with electronic case report form systems such as Medidata Rave, Inform, TrialKit, etc. preferred
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
Ability to travel for site network support, audits and or attend investigator meetings, as required.

Nice To Haves

Previous nursing, medical assistant experience in a clinical setting a plus
CCRC certification a plus
Bilingual Required (location specific): Proficiency in Spanish and English, including the ability to speak, read, and write in both languages
Familiarity with electronic case report form systems such as Medidata Rave, Inform, TrialKit, etc. preferred
Strong study documentation skills in compliance with ALCOA+ preferred

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