Clinical Research Coordinator

TEXAS DIABETES & ENDOCRINOLOGY PA - 3.8

Austin, TX Job Details 10 hours ago Qualifications Laboratory sample storage Data integrity assurance Version control Incident reporting compliance Healthcare incident report preparation CPR Certification Laboratory inventory control Quality records maintenance Informed consent LVN Laboratory equipment routine checks Pre-examination patient preparation Adverse event reporting Labeling Operations coordination BLS Certification HIPAA Filing Good documentation practices (GDP) Care documentation Phlebotomy specimen handling Laboratory equipment calibration Patient safety Research project coordination ICH guidelines Health information data integrity Product management Data quality monitoring Adverse drug reaction monitoring Informed consent procedures implementation Full Job Description Texas Diabetes and Endocrinology PA (TD&E) has grown over the years to meet the Endocrinology needs of the Austin community. Our mission is to strive to provide expert care in Diabetes Thyroid problems Osteoporosis Weight management and hormonal conditions by providing thorough evaluations and innovative personalized solutions focused on our patients success. Our employees are the strength that keeps us moving forward. Our Clinical Research Department is looking for a Clinical Research Coordinator CRC I role at our Central location

Purpose:

The Clinical Research Coordinator I CRC I is an entry level research professional who supports the conduct of Phase II IV clinical trials under the direct supervision of the Principal Investigator PI and senior research staff. The CRC I assists with day to day study operations to ensure participant safety data integrity and compliance with the protocol Good Clinical Practice GCP Institutional Review Board IRB requirements and applicable regulatory guidelines. This role serves as a key liaison between participants the research team and study sponsors contributing to high quality trial execution and audit readiness. Essential Functions Study Coordination Supports the coordination of assigned clinical trials in accordance with the protocol ethical principles and regulatory requirements Maintains working knowledge of study procedures visit schedules investigational product IP requirements and data collection processes Assists with specimen collection labeling processing storage and shipment per protocol and laboratory standards Communicates with central and local laboratories to resolve missing results or data discrepancies Monitors study supply inventory and ensures equipment is functioning and calibrated as required Participates in site initiation visits monitoring visits investigator meetings and required study training Maintains documentation to support inspection readiness including version control of study materials Participant Management Assists with screening recruitment and enrollment of participants including obtaining HIPAA authorization and informed consent under PI supervision Reviews medical records and pre screening information to assess eligibility escalates eligibility questions to the PI Performs permitted clinical procedures for example vital signs phlebotomy ECGs and collects protocol required data Educates participants on study procedures visit expectations device usage for example pumps and meters and safety considerations Monitors participant adherence safety and well being throughout study participation Documents all study activities in source documents and case report forms CRFs following Good Documentation Practices GDP Supports investigational product management including receipt storage preparation accountability and destruction under PI or pharmacist oversight Identifies documents and promptly reports adverse events AEs and serious adverse events SAEs in accordance with regulatory and sponsor requirements Reviews participant diaries questionnaires and patient reported outcomes for completeness and protocol compliance Provides a safe environment for participants and staff by adhering to OSHA CDC and institutional safety standards Regulatory Compliance Conducts study activities in accordance with

ICH GCP E6 R3

emphasizing participant protection data reliability and risk based quality principles Ensures timely communication of study updates safety reports and regulatory documents to the Regulatory Specialist for filing Supports maintenance of essential documents and contributes to audit and inspection readiness Follows institutional SOPs and reports deviations or non compliance to the PI and Quality Assurance team Collaboration and Communication Maintains clear timely communication with the PI regarding study progress participant concerns and protocol issues Collaborates with the Director of Operations Regulatory Specialist QA Supervisor Data Entry Coordinators and other team members to ensure smooth study operations Works closely with sponsor Clinical Research Associates CRAs during monitoring visits and supports resolution of data queries Assists recruitment staff with implementing study specific recruitment strategies Contributes to a positive collaborative team environment

Additional Non Essential Functions:

Assists other CRCs with participant visits as needed Performs other duties as assigned to support study operations Education & Experience Requirements Minimum Required Prior experience as a Clinical Research Coordinator or similar role in a medical setting Preferred Good Clinical Practice Certification At least 2 years of experience as a Clinical Research Coordinator or similar role Experience in diabetes and or endocrine clinical care or research Prior patient care experience MA LVN RN or similar CPR AED certification AAP/EEO Statement Texas Diabetes and Endocrinology, P.A. TDE provides equal employment opportunities EEO to all employees and applicants for employment in accordance with applicable federal, state, and local laws. TDE complies with applicable state and local laws governing nondiscrimination in employment in every location in which it has facilities. Other Duties Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.