Clinical Research Coordinator – Austin Regional Clinic, Austin, TX

# Clinical Research Coordinator Austin Regional Clinic - Austin, TX 78726## Overview Salary Range $53,411.20 - $73,440.40 Salary/year Position Type Full Time Job Shift Day Education  Level Bachelor's Degree## Description
** JOB SUMMARY
** A Clinical Research Coordinator (CRC) is responsible for reviewing, processing, and managing clinical research data and documents, both regulatory and patient records. The CRC performs a variety of clinical procedures, and assists with daily workload planning; ie; collect, record, report, and interpret data on patients enrolled in and/or seeking enrollment in clinical studies according to the protocol, SOPs, and GCPs.

** RESPONSIBILITIES
* ** Provide clinical research support to investigators to prepare for and execute assigned research studies, including:  + Collect, record, and maintain research subject study data according to study protocols and SOPs, preserving quality control for content, accuracy, and completeness.  + Collect and submit regulatory/ethics documentation as required by the FDA and other regulatory bodies governing the conduct of clinical research.  + Recruit and screen participants for clinical trials and maintain subject screening logs.  

+ Assist in the initial and ongoing consent process; orient research subjects to the study, including the purpose of the study, procedures, and research process.  + Maintain source documentation based on protocol requirements.  + Schedule and execute study visits and perform study procedures.  + Handle lab testing and analysis, including preparation of specimen collection tubes, shipment, and lab logistics.  + Monitor subject safety and report adverse events/reactions to the Principal Investigator and/or appropriate medical personnel.  

+ Correspond with research subjects and troubleshoot study-related questions or issues.  + Participate in “huddles” to confirm daily study tasks are assigned to team members and are executed to the expected standards.
* Assist with study data quality checking and query resolution.
* Perform a variety of complex clinical research procedures including but not limited to ECG, sample collection, spirometry, vital signs, dose verification, cannulation, and cardiac telemetry monitoring, if needed.
* Assist the investigator in verifying that research study objectives are met on time, within budget, and according to applicable protocol requirements, clinical research regulations, and quality standards.
* Provide training to new investigator site staff members on study-specific topics and requirements.  Assist in maintaining adherence to investigator site staff training requirements by auditing and maintaining training records.
* Prepare for and attend study monitoring visits, study audits, and regulatory inspections with clinical research regulatory agencies.
* Assist the research site with coverage planning related to staffing and scheduling for research studies.
* Monitor subject safety and report adverse reactions to appropriate medical personnel.
* Maintain confidentiality of data and PHI as required.
* Collaborate with provider offices to carry out research in the most efficient workflow possible.
* Maintains stock of supplies needed to carry out each study per protocol.
* Performs other duties and projects as assigned.## Qualifications
** QUALIFICATIONS
* ** Bachelor's degree in a related field
* 1-2 years of clinical research experience
* Relevant work experience in a clinical environment or medical setting, e.g., medical assistant, assistant nurse, laboratory technician; or equivalent combination of education, training, and experience
* Proficient in the use of Microsoft Office applications
* Understanding of medical terminology
* Working knowledge of clinical trials
* Knowledge and ability to apply GCP/ICH and all applicable FDA regulations and guidelines for human subject protection, drug, and device.
* In-depth knowledge of departmental, protocol, and study-specific operating procedures, consent forms, and study schedules
* Skilled in carrying out required clinical procedures such as phlebotomy and vital signs.
* Strong written and verbal communication skills including good command of the English language.
* Skill in applying and modifying professional research principles, methods, and techniques to provide ongoing patient care.
* Skill in preparing/maintaining records, writing reports, and responding to correspondence.
* Ability to maintain quality control standards.
* Ability to react calmly and effectively in all…