Clinical Research Coordinator

*** This is a contract position with potential to turn into full-time. ***

Our client is a leading innovator specializing in minimally invasive solutions that are redefining the boundaries of oncology treatment.

The Clinical Research Coordinator (CRC) assists with the planning, development, and execution of high-quality clinical activities. This role is ideal for someone with an interest in learning and developing skills in clinical research, research methodology, regulations, and applicable guidelines including FDA regulations, international regulatory standards, Good Clinical Practice (GCP), ISO compliance, and company SOPs.

The CRC role supports the broader clinical operations team by coordinating study activities and maintaining documentation standards. The CRC must demonstrate strong organizational skills, attention to detail, and the ability to produce high-quality work under tight timelines. The CRC collaborates with the internal team, contract research organizations (CROs), study personnel, and other vendors throughout the execution of clinical trials.

This is an entry-level position perfect for someone eager to build a strong foundation in clinical research.

• Support clinical trials in collaboration with other clinical team members pertaining to site qualification, initiation, site management, data management and other ongoing tasks to support clinical trials
• Perform study related activities in compliance with GCP and FDA regulations for clinical trials
• Contribute to the formatting of study documents and manage the upload and tracking of clinical documents into the Quality Management System (QMS)
• Ensure ordering of clinical study supplies when needed
• Assemble and distribute study related documents including regulatory binders, case report form binders, study manuals, retention initiatives, and other study related tools to sites
• Creation and maintenance of study trackers, dashboards, and reports
• Support clinical study payments, where applicable
• Participate in study-specific meetings, record meeting minutes including issues and actions items; and file minutes accordingly
• Manage and track the electronic (and/or paper) study site and master files, ensuring audit readiness
• Create and distribute study specific newsletters to the clinical sites
• Provide travel and logistical support to physician proctors and clinical team as needed
• Support the planning and conduct of investigator/study meetings
• Ensure proper handling, accountability, and reconciliation of all Investigational Product (IP)
• Assist with clinical trials.gov updates
• Complete Central IRB submissions
• Complete submission to the QMS
• Organize and manage the Clinical Site email inbox
• Facilitate licensing agreements with respective vendors
• Facilitate document translations with respective vendors
• Develop and maintain successful working relationships, manage deliverables, and provide feedback to cross functional team members.

• Excellent organizational skills
• Excellent interpersonal, written, and verbal communication skills
• Effectively build and maintain positive relationships with physicians, peers, and colleagues across all organizational levels
• Ability to multitask effectively while maintaining high quality outputs

• Bachelor's Degree
• Proven experience working within an FDA IDE pre‑market clinical studies, post‑market studies or registries
• Strong knowledge and understanding of prostate anatomy

• Occasionally exerting up to 20lbs and lifting to 50lbs
• Significant work pace and pressure due to deadlines of a start‑up organization
• Operate a computer, and other office equipment, proficient in Microsoft Office software
• Travel may be required (up to 5%); to assist with the logistics of Investigator and Research Coordinator meetings