Clinical Research Coordinator II

Johnson County Clintrials LLC•Houston, TX

18d•Onsite

About The Position

The Clinical Research Coordinator II role is responsible for 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 role involves coordinating and administering overlapping clinical studies, serving as the main point of contact for sponsors, and performing diverse administrative duties requiring analysis, sound judgment, and a high-level knowledge of study-specific protocols.

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.
Bilingual Required (location specific): Proficiency in Spanish and English, including the ability to speak, read, and write in both languages.
Writing and verbal communication skills.
Strong study documentation skills in compliance with ALCOA+ 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.
Familiarity with electronic case report form systems such as Medidata Rave, Inform, TrialKit, etc. 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.