Cypress HCM
The Clinical Trial Documentation Coordinator plays a vital role within the Clinical Operations team, providing seasoned administrative and logistical support across a variety of clinical trial activities. This role is responsible for ensuring studies are well-organized, audit-ready, and progressing smoothly by flexibly managing documentation, image and data tracking, payments, device logistics, and meeting coordination. As a core and consistent member of the team, the Clinical Coordinator is regarded as a peer among fellow coordinators and a reliable contributor to study success.
Responsibilities: Clinical Documentation & Site Support Manage essential clinical documentation, including IRB approvals, informed consent forms, agreements, and regulatory files. Track and update CVs and credentials for study site personnel. Serve as a primary contact for clinical sites regarding documentation needs and visit scheduling. Maintain organized, audit-ready study files within electronic systems. Image & Data Management Coordinate the collection, processing, and tracking of clinical images and related data from sites and core labs. Troubleshoot and resolve data submission issues with sites and vendors to ensure completeness and timeliness. Ensure image data quality and compliance by maintaining accurate records in the EDC system. Payments & Financial Tracking Process payments to study sites, vendors, core labs, and data management groups. Maintain and update payment tracking databases; provide accrual information to the Finance team. Communicate regularly with vendors and sites to support timely and accurate financial transactions. Device & Logistics Coordination Manage logistics for study device shipments, returns, and related documentation. Track device inventory, usage, and return status. Collaborate with Operations to facilitate purchase orders and coordinate shipping logistics. Meeting & Training Support Assist with planning and coordinating investigator meetings, site coordinator trainings, and study committee meetings (in-person and virtual). Support travel arrangements and meeting logistics as needed. Prepare training materials, track participant attendance, and monitor related expenses. General Team Support Assemble and maintain study materials, binders, and equipment supplies. Provide backup support to fellow Clinical Coordinators during periods of high workload. Participate in continuous improvement efforts and team-wide initiatives.
Qualifications: Associate or Bachelor’s degree required; degree in life sciences, healthcare, or a related field preferred. 3–5 years of experience in clinical research, clinical trials, or a regulated healthcare setting. Strong understanding of clinical documentation requirements and trial operations. Proficient in Microsoft Office (Excel, Word, PowerPoint, Outlook); experience with EDC systems or clinical databases is highly preferred. Exceptional organizational skills with the ability to handle multiple priorities in a dynamic environment. High attention to detail, accuracy, and follow-through. Excellent communication skills and the ability to foster productive relationships with internal teams, clinical sites, and vendors. Demonstrated dedication to a coordinator-level role and a commitment to team stability and performance.
Salary of $60,000 to $80,000 + 5 to 7 % bonus
Responsibilities: Clinical Documentation & Site Support Manage essential clinical documentation, including IRB approvals, informed consent forms, agreements, and regulatory files. Track and update CVs and credentials for study site personnel. Serve as a primary contact for clinical sites regarding documentation needs and visit scheduling. Maintain organized, audit-ready study files within electronic systems. Image & Data Management Coordinate the collection, processing, and tracking of clinical images and related data from sites and core labs. Troubleshoot and resolve data submission issues with sites and vendors to ensure completeness and timeliness. Ensure image data quality and compliance by maintaining accurate records in the EDC system. Payments & Financial Tracking Process payments to study sites, vendors, core labs, and data management groups. Maintain and update payment tracking databases; provide accrual information to the Finance team. Communicate regularly with vendors and sites to support timely and accurate financial transactions. Device & Logistics Coordination Manage logistics for study device shipments, returns, and related documentation. Track device inventory, usage, and return status. Collaborate with Operations to facilitate purchase orders and coordinate shipping logistics. Meeting & Training Support Assist with planning and coordinating investigator meetings, site coordinator trainings, and study committee meetings (in-person and virtual). Support travel arrangements and meeting logistics as needed. Prepare training materials, track participant attendance, and monitor related expenses. General Team Support Assemble and maintain study materials, binders, and equipment supplies. Provide backup support to fellow Clinical Coordinators during periods of high workload. Participate in continuous improvement efforts and team-wide initiatives.
Qualifications: Associate or Bachelor’s degree required; degree in life sciences, healthcare, or a related field preferred. 3–5 years of experience in clinical research, clinical trials, or a regulated healthcare setting. Strong understanding of clinical documentation requirements and trial operations. Proficient in Microsoft Office (Excel, Word, PowerPoint, Outlook); experience with EDC systems or clinical databases is highly preferred. Exceptional organizational skills with the ability to handle multiple priorities in a dynamic environment. High attention to detail, accuracy, and follow-through. Excellent communication skills and the ability to foster productive relationships with internal teams, clinical sites, and vendors. Demonstrated dedication to a coordinator-level role and a commitment to team stability and performance.
Salary of $60,000 to $80,000 + 5 to 7 % bonus