Clinical Research Coordinator II

Johnson County Clintrials • Houston, TX

8d

About The Position

The Clinical Research Coordinator II coordinates and administers multiple overlapping clinical studies, serving as the main point of contact for sponsors on assigned trials and as a liaison among investigators, study teams, sponsors, and clinical staff. The role requires sound judgment, strong organizational and communication skills, and advanced knowledge of study-specific protocols to support protocol compliance, regulatory and documentation standards, and high-quality clinical research.

Requirements

• Bachelor's degree in life science or a related discipline, or equivalent work experience.
• Basic understanding of clinical research regulations, including CFR, GCP, and HIPAA.
• At least 3 years of experience coordinating clinical trials, including related activities listed in the posting.
• Strong relationship-building skills and 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.
• Ethical and professional conduct.
• Proficiency with word processing, spreadsheets, databases, presentation software, Microsoft Office applications (Outlook, Word, Excel, PowerPoint, and SharePoint), and regulatory filing systems.
• Excellent communication, interpersonal, analytical, and problem-solving skills.
• Ability to work effectively with a team and manage multiple projects simultaneously.
• Time-management and organizational skills; accuracy and attention to detail.
• Critical thinking and problem-solving skills; self-motivation, results orientation, multitasking ability, and capacity to learn quickly.
• Ability to sit, stand, walk, reach with hands and arms, use hands and fingers to handle or feel, and 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 compliant with ALCOA+.
• Familiarity with electronic case report form systems such as Medidata Rave, Inform, or TrialKit.

Responsibilities

• Develop working relationships and serve as the clinic and sponsor point of contact for clinic-related activities.
• Manage multiple concurrent trials.
• Assist with mentoring and training study team members.
• Maintain study activity 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 about laboratory procedures and findings.
• Educate volunteers about 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, and updated guidelines.
• Communicate ongoing study updates and changes to nursing staff, when applicable.
• Keep investigators informed about study progress, safety issues, and other important information.
• Maintain contact with sponsors and CROs, respond promptly, and coordinate site visits.
• Communicate and collaborate professionally with CRAs during site visits.
• Order and track supplies or devices needed to complete studies.
• Prepare study source documentation according to protocol and system guidelines, and collaborate with the QA department on 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 volunteer interviews, vital-sign measurements, and electrocardiograms.
• Prepare for or participate in quality assurance audits conducted by sponsors, federal agencies, or designated review groups.
• Collect, process, and ship laboratory specimens.
• Follow safety and privacy regulations.
• Travel for site network support, audits, or investigator meetings as required.

Benefits

• The company describes a family-focused environment and support for employees, but does not specify formal benefits.

What This Job Offers

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