Clinical Research Coordinator I at Texas Diabetes & Endocrinology, P.A. in Central Office (Mopac/Far West) - Central Austin, TX 78731

Job description

• 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.

Responsibilities

• 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
• Assists other CRCs with participant visits as needed
• Performs other duties as assigned to support study operations

Requirements

• Minimum Required
• Prior experience as a Clinical Research Coordinator or similar role in a medical setting
• 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

Skills

Preferred

• Good Clinical Practice Certification
• CPR AED certification