What are the responsibilities and job description for the Clinical Research Coordinator position at Clinical Research Solution?
Company Description Clinical Research Solution is a Site Management Organization focused on optimizing clinical research operations and improving patient outcomes. The company streamlines the complexities of clinical trials by offering innovative solutions that enhance efficiency, compliance, and data quality. Working closely with research sites, sponsors, and CROs, Clinical Research Solution supports study management, patient recruitment, and regulatory adherence. By combining cutting-edge technology with deep industry expertise, the organization enables healthcare professionals to conduct high-quality research and accelerate the development of life-changing treatments. A strong commitment to collaboration, robust data management, and a patient-centric approach drives all aspects of the company’s work.
Role Description This is a full-time, on-site Clinical Research Coordinator role based in Cypress, TX. The Clinical Research Coordinator will manage day-to-day clinical trial activities, including scheduling and coordinating participant visits, preparing study materials, and maintaining accurate source documents and case report forms. This role will support investigators in implementing study protocols, ensure timely collection and entry of study data, and monitor adherence to regulatory and sponsor requirements. The coordinator will facilitate the informed consent process, maintain communication with study participants, and address questions or concerns in a professional and compassionate manner. Additional responsibilities include coordinating with sponsors and CROs, preparing for monitoring visits and audits, managing investigational product accountability as applicable, and contributing to continuous improvement of site processes.
Qualifications
- Clinical research foundations: Strong understanding of clinical research principles, including Research methods and experience with Clinical Trials.
- Study conduct and protocol adherence: Demonstrated Clinical Research Experience with implementing and following Protocol requirements in a regulated environment.
- Participant safety and ethics: Proficiency in conducting and documenting the Informed Consent process in accordance with ethical and regulatory standards.
- Regulatory and operational skills: Knowledge of GCP/ICH guidelines, IRB processes, and regulatory documentation; experience preparing for monitoring visits and audits.
- Data and documentation: Ability to maintain accurate source documents, perform timely data entry, and ensure data integrity and confidentiality.
- Communication and collaboration: Effective written and verbal communication skills, with the ability to work closely with investigators, participants, sponsors, and CROs.
- Organizational skills: Strong attention to detail, time management, and the ability to manage multiple studies or tasks in a fast-paced environment.
- Education and credentials: Bachelor’s degree in a health-related, science, or related field preferred; certification as a Clinical Research Coordinator (e.g., ACRP, SOCRA) is a plus.
- Experience: Prior on-site clinical research coordination experience in outpatient or site-based settings strongly preferred; familiarity with electronic data capture and site management systems is beneficial.