Clinical Research Coordinator II

About the Role

The Clinical Research Coordinator II ensures the successful execution of multiple concurrent clinical trials through effective study coordination, subject management, and cross-functional communication. This role serves as the 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.

Responsibilities

• Develop strong working relationships and become the point of contact for the clinic and sponsors 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 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 professional and accountable manner following protocol requirements.
• Ensure training and documentation are completed for protocol amendments, ICFs, updated guidelines, etc.
• Communicate with Nursing staff (if applicable) on an ongoing basis regarding study updates, amendments, or changes.
• Communicate with Investigators regarding study progress, safety issues, and other important information.
• Maintain contact with sponsors/CROs, respond in a timely manner, and schedule/coordinate site visits.
• Order and track supplies or devices necessary for study completion.
• Prepare study-related source documentation according to protocol and system guidelines and collaborate with the QA department 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 the Clinical Conductor system.
• Perform specific 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 specially designated review groups.
• Collect, process, and ship laboratory specimens.
• Adhere to safety and privacy regulations.

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.
• Previous nursing or medical assistant experience in a clinical setting is a plus.
• CCRC certification is a plus.
• Demonstrated relationship-building skills with strong verbal and written communication.
• Ability to successfully coordinate protocols with overlapping timelines.
• Ability to explain the 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.
• Proven ethical and professional codes of conduct.
• Proficiency with word processing, spreadsheet, database, and presentation software (MS Office skills such as Outlook, Word, Excel, PowerPoint, SharePoint) and regulatory filing systems.

Skills

• Excellent communication, interpersonal, analytical, and problem-solving skills.
• Microsoft Office Suite proficiency.
• Bilingual (location specific): Proficiency in Spanish and English, including speaking, reading, and writing in both languages.
• 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 and organizational skills.
• Detail-oriented with the ability to perform at a high level of accuracy.
• Strong critical thinking and problem-solving skills.
• Self-motivated and results-oriented.
• Ability to multitask and quickly learn new concepts.
• Ability to travel for site network support, audits, or to attend investigator meetings, as required.

Physical Requirements

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

• Ability to sit, stand, walk, reach with hands and arms, and use hands along with fingers to handle or feel.
• Ability to lift and/or move up to 20 pounds.

About JCCT

JCCT has provided exceptional customer service to clients, volunteers, and vendors for the last 20 years. This team effort has resulted in the company being recognized as one of the best clinical research sites in the United States. JCCT is actively growing through acquisition and organic growth and seeks high-performing individuals to support continued success. Our clients come from all over the world to place studies at our research sites.

JCCT promises to support, accept, and respect you as an individual in a family-focused environment. Our vision is to make a difference in the world by improving the health and well-being of others through pharmaceutical research and drug development. Our impact is driven by genuine care, support, and customer service provided to employees, volunteers, and sponsors.