Clinical Research Coordinator II

Johnson County Clintrials LLC • Houston, TX

18h • $27 - $32

About The Position

The Clinical Research Coordinator II coordinates and administers multiple overlapping clinical studies. The role serves as the main point of contact for sponsors on assigned trials and as a liaison among investigators, study teams, sponsors, and clinical staff. It requires advanced knowledge of study-specific protocols, sound judgment, strong organization, and the ability to prioritize and adapt to changing conditions. The position reports to the Site Manager or Site Director.

The coordinator supports protocol compliance, regulatory and documentation standards, participant safety, and the quality and timely conduct of clinical research. Responsibilities include managing study activities and participant appointments, assessing eligibility, maintaining study records, communicating study updates and safety information, coordinating with sponsors and clinical staff, and supporting audits. The role may also involve performing protocol procedures, collecting and shipping laboratory specimens, and mentoring and training team members.

JCCT describes its environment as family-focused and emphasizes customer service, employee support and respect, and opportunities for personal growth. The company conducts pharmaceutical research and drug-development work and states that it provides equal employment opportunities.

Requirements

• Bachelor of Science or Bachelor of Arts in Life Science or a related discipline, or equivalent work experience.
• At least 3 years of experience coordinating clinical trials, including the activities listed in the posting.
• Basic understanding of regulations governing clinical research, including CFR, GCP, and HIPAA.
• Demonstrated relationship-building ability and strong verbal and written communication skills.
• Ability to coordinate protocols with overlapping timelines.
• Ability to explain the importance and application of GCP guidelines.
• Ability to train others in study coordination responsibilities and protocol adherence.
• Ability to follow participant safety requirements, including the informed consent process, the role of the IRB, and adverse-event reporting.
• Strong interpersonal skills and attention to detail.
• Demonstrated ethical and professional conduct.
• Proficiency with word-processing, spreadsheet, database, and presentation software, including Microsoft Outlook, Word, Excel, PowerPoint, and SharePoint, and with regulatory filing systems.
• Excellent communication, interpersonal, analytical, and problem-solving skills.
• Ability to work effectively with a team and prioritize and manage multiple projects simultaneously.
• Time-management and organizational skills.
• Ability to perform accurately at a high level of detail.
• Strong critical-thinking and problem-solving skills.
• Self-motivated, results-oriented, able to multitask, and a quick learner.
• Ability to sit, stand, walk, reach with hands and arms, and use hands and fingers to handle or feel.
• Ability to lift and/or move up to 20 pounds.

Nice To Haves

• Previous nursing or medical assistant experience in a clinical setting.
• CCRC certification.
• Strong study documentation skills in compliance with ALCOA+.
• Familiarity with electronic case report form systems such as Medidata Rave, Inform, or TrialKit.
• Bilingual proficiency in Spanish and English, including speaking, reading, and writing, where required by location.

Responsibilities

• Develop strong working relationships and serve as a point of contact for the clinic and sponsors for clinic-related activities.
• Manage multiple concurrent clinical trials.
• Assist with mentoring and training study team members.
• Maintain study records, including study logs, case report forms, and regulatory forms.
• Schedule volunteers for appointments, procedures, and inpatient stays as required by study protocols.
• Assess potential volunteer eligibility through interviews, medical-record reviews, and discussions with Investigators and Research Associates.
• Communicate with Laboratory staff and Investigators regarding laboratory procedures and findings.
• Educate study volunteers on study procedures, diary completion, electronic devices, and expected outcomes in accordance with protocols.
• Ensure training and documentation are completed for protocol amendments, informed consent forms, updated guidelines, and related changes.
• Communicate ongoing study updates and amendments to Nursing staff, when applicable.
• Keep Investigators informed about study progress, safety issues, and other important information.
• Maintain timely communication with sponsors and CROs and schedule or coordinate site visits.
• Communicate professionally and collaborate with CRAs during site visits.
• Order and track supplies or devices needed to complete studies.
• Prepare study-related source documentation according to protocol and system guidelines and collaborate with Quality Assurance to make appropriate changes.
• Record adverse events and discuss reporting to oversight agencies with Investigators.
• Track volunteer enrollment status and documentation in the Clinical Conductor system.
• Perform protocol procedures such as interviewing volunteers, taking vital signs, and performing electrocardiograms.
• Prepare for or participate in quality assurance audits conducted by sponsors, federal agencies, or designated review groups.
• Collect, process, and ship laboratory specimens.
• Adhere to safety and privacy regulations.
• Travel for site-network support, audits, or investigator meetings as required.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level