Clinical Research Coordinator - Urology

General Summary/Responsibilities: Assist with completion of study start-up documents, including IRB submission and regulatory Complete and maintain regulatory documents, updating as needed Organize and maintain the regulatory binder(s), file essential documents, obtain signatures as needed Ensure timeliness and accurate submission of all regulatory/essential documents Obtain and maintain updated lab/test ranges, documentation of required licensure/certification Maintain calibration records Prepare regulatory binder(s) for monitor visits, audits, or site inspections ensuring a neat, orderly, thorough regulatory binder Ensures all regulatory documents are filed in appropriate binder and correspondence/forms are submitted in a timely manner; files regulatory documents within 5 days of receipt; maintains neat and orderly binders. Assists in developing procedures to ensure regulatory compliance Maintain investigator(s) CV, medical licenses, and certifications Schedule patient procedures and visits in accordance with protocol requirements; maintain a calendar of patient appointments in accordance with protocol schedule of events Process patient encounters by entering data on protocol-specific worksheet Process patient stipend forms to the research manager Perform timely EDC, eTMF, and other study-related vendor portal data entry, within 48-72 hours of visit Manage and respond to queries/data clarifications adequately and within 5 days of receipt Together with investigator/sub-I, monitor for adverse events/serious adverse events. Notify the study investigator immediately of any adverse event/serious adverse event. Notify sponsor/IRB as per protocol requirements. Assure accurate and timely documentation of any adverse event/serious adverse event. Inform patient of any changes in protocol, safety information, visit requirements by obtaining updated informed consent as required by sponsor Coordinate monitor visits, ensure all source data is complete, accurate and signed and all CRFs/EDC are complete, all queries/data clarifications have been responded to Assist in maintaining federal and GCP/ICH compliance during the conduct of the protocol Obtain enrolled patient QOLs, diaries, and other data completed by the enrolled patient Assist in completion of various trackers, data metrics, preparation for Site Initiation Visits, Pre-Qualification Visits, Interim Monitor Visits, Close-out Visits, and Meetings. Perform other related duties as directed or assigned. Qualifications Skills/Abilities Must be patient service focused with the ability to deliver high patient satisfaction. Excellent communications skills required, ability to develop relationships with patients to provide a positive experience, along with the clinical research associates (CRA) with the sponsor that is assigned to our site. Knowledge of accurate data entry skills Knowledge of medical terminology Self-starter with the ability to complete daily tasks with minimal supervision. Skill in communicating effectively with patients, staff, or providers about research studies. Ability to multitask effectively, dealing with phone calls, in-office patients, staff, and others in a pleasant manner along with multiple tasks/studies. Ability to analyze situations and respond appropriately. Ability to speak clearly and concisely to be heard by callers and patients. Excellent organizational and time management skills. Superior interpersonal and problem-solving skills to ensure coordinated efforts and patient satisfaction. Always maintain a professional and positive attitude. Demonstrate teamwork and support for fellow department team members; can be flexible when necessary. Urology experience is preferred but not required. Bilingual (Spanish) is preferred but not required. Experience: Two years of clinical trial research experience (required) Ability to prioritize multiple tasks/projects Ability to handle and keep up with a fast-paced, high patient volume doctor's office Education: High school diploma or GED (required) Associates or Bachelor's Degree (preferred) Schedule: 8 hour shift with a 30 minute unpaid lunch break Monday to Friday Travel: Ability to travel between our five clinic locations, as well as to our ASC, depending on where the clinical trial visits are located or where patients are scheduled for consenting and/or performing study procedures.

Created: 2026-03-04