Clinical Research Coordinator

Overview

Come join our team and make a difference as we blaze the way into the future of medical discovery through world-class clinical research. At Pinnacle Clinical Research, we are committed to driving innovation and advancing medical knowledge. Through our rigorous research studies, we strive to unlock breakthroughs that have the potential to transform patient care and improve lives. We pride ourselves on conducting high quality research as a complement to the medical care that our volunteers receive from their routine care center.

Together, we will raise awareness about the importance of clinical research and its role in shaping the future of healthcare. Be a part of the discovery!

Summary: PCR seeks a Clinical Research Coordinator who will manage the day-to-day operations of assigned clinical trials, assist in project planning, and ensure pre-established work scope, study protocol, and regulatory requirements are followed. They will attend meetings and events to promote studies, recruit and screen study participants, and document and report on the daily operations and participant status. This person must understand clinical trial priorities and establish a workflow to complete all required activities in a timely manner.

This position involves a broad range of duties involving confidential information. The Clinical Research Coordinator I must be organized, able to multi-task, detail-oriented, an excellent communicator, and capable of providing high quality patient care. This role reports directly to the Clinical Research Project Manager.

• Exercise judgement within the limits defined by clinical trial protocols, standard operating procedures, and direction from the study investigator, Project Manager, and Director of Clinical Research Operations.
• Maintain subject and document confidentiality and comply with sponsor requirements and regulations (FDA, GCP, ICH, HIPAA, IRBs, and institutional policies).
• Complete study-directed assessments with patients (e.g., informed consent, subject history, adverse events, Fibroscan, test article handling, appointment scheduling, records review, treatment coordination, vital signs, and health assessment).
• Create and complete study-related documents and new study preparations.
• Function as a liaison with pharmaceutical sponsors and external vendors.
• Prepare for study monitor visits (onsite or remote) and audit inspections.
• Respond to internal and external information requests in a timely manner.
• Perform subject screening and recruitment.
• Contribute to data management for research projects.
• Identify opportunities to improve patient care and satisfaction.
• Conduct patient-facing encounters with compassion and thoroughness.
• Review medical records against inclusion/exclusion criteria to identify potential subjects.
• Ensure subjects qualify for study prior to dosing and remain monitored post-dose.
• Obtain and document adverse event data on appropriate forms.
• Ensure source documents are transcribed to the EDC platform per protocol on a timely manner.
• Ensure EDC queries are answered within the required time.
• Resolve other study-related queries within a reasonable time.
• Interact with physicians, nurses, administration staff, sponsor representatives, central laboratory and imaging personnel, and clinical trial patients.
• Coordinate multiple projects with competing priorities and deadlines as directed by protocol and study volume.
• Attend investigator meetings, pre-study site visits, study initiation visits, and other study-related visits hosted by monitors or sponsor representatives.

• Ensure electronic case report forms are completed.
• Create memos, emails, and letters related to study activities.
• Create and maintain reports and/or spreadsheets as requested.
• Enter all patient data into the clinical trial management system in a timely manner.
• Maintain study documents and ensure electronic regulatory documents are saved and uploaded in the appropriate sections.
• Report safety information to all regulatory agencies.
• Understand regulatory and IRB requirements for studies.
• Perform quality checks on source documents specific to the study.
• Assist with Corrective Action…