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About the Role
The Clinical Research Coordinator I (CRC I) is an entry-level research professional supporting Phase II-IV clinical trials under the direct supervision of the Principal Investigator (PI) and senior research staff. This role ensures participant safety, data integrity, and compliance with protocols, GCP, IRB, and regulatory guidelines, acting as a key liaison between participants, the research team, and sponsors.
Responsibilities
- Supports the coordination of assigned clinical trials.
- Maintains knowledge of study procedures, visit schedules, and IP requirements.
- Assists with specimen collection, labeling, processing, storage, and shipment.
- Communicates with laboratories to resolve data discrepancies.
- Monitors study supply inventory and equipment.
- Participates in site initiation visits, monitoring visits, investigator meetings, and study training.
- Maintains documentation for inspection readiness.
- Assists with screening, recruitment, and enrollment of participants.
- Reviews medical records and pre-screening information for eligibility.
- Performs permitted clinical procedures and collects protocol-required data.
- Educates participants on study procedures, visit expectations, device usage, and safety.
- Monitors participant adherence, safety, and well-being.
- Documents all study activities in source documents and CRFs.
- Supports investigational product management.
- Identifies, documents, and reports adverse events (AEs) and serious adverse events (SAEs).
- Reviews participant diaries, questionnaires, and patient-reported outcomes.
- Provides a safe environment for participants and staff.
- Conducts study activities in accordance with ICH GCP E6 R3.
- Ensures timely communication of study updates, safety reports, and regulatory documents.
- Supports maintenance of essential documents.
- Contributes to audit and inspection readiness.
- Follows institutional SOPs and reports deviations.
- Maintains clear and timely communication with the PI.
- Collaborates with the Director of Operations, Regulatory Specialist, QA Supervisor, and Data Entry Coordinators.
- Works closely with sponsor CRAs during monitoring visits and supports query resolution.
- Assists recruitment staff with recruitment strategies.
- Contributes to a positive and collaborative team environment.
- Assists other CRCs with participant visits as needed.
- Performs other duties as assigned to support study operations.
Requirements
- Minimum of 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.
- CPR/AED certification.
- Must be able to obtain Good Clinical Practice Certification.
Skills
- Clinical research coordination
- Phase II-IV clinical trials
- Participant safety
- Data integrity
- Protocol compliance
- Good Clinical Practice (GCP)
- Institutional Review Board (IRB) requirements
- Regulatory guidelines
- Specimen collection, labeling, processing, storage, and shipment
- Laboratory communication
- Study supply inventory management
- Equipment calibration
- Site initiation visits
- Monitoring visits
- Investigator meetings
- Study training
- Documentation and version control
- Participant screening, recruitment, and enrollment
- HIPAA authorization
- Informed consent
- Medical record review
- Eligibility assessment
- Vital signs
- Phlebotomy
- ECGs
- Data collection
- Participant education
- Investigational product management
- Adverse event reporting
- Patient-reported outcomes
- OSHA safety standards
- CDC safety standards
- Institutional safety standards
- ICH GCP E6 R3
- Risk-based quality principles
- Regulatory document filing
- Institutional SOPs
- Deviation reporting
- Quality Assurance
- Communication
- Collaboration
- Sponsor CRA interaction
- Data query resolution
- Recruitment strategy implementation
- Teamwork
Location
- Central Office (Mopac/Far West) - Central Austin, TX 78731
Work Type
- Full-time
Experience Level
- Entry level
- 2 years of experience
Education Level
- MA, LVN, RN, or similar
About the Company
- 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.
Equal Opportunity
- 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.