Clinical Research Coordinator at Medix™ Texarkana, TX

Benefits

Job Description

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 situations
• •Excellent organizational and problem-solving skills
• •Effective time management skills with the ability to multi-task and manage competing priorities with exceptional attention to detail
• •Ability to establish and maintain effective working relationships with physicians, coworkers, managers, and clients
• •Practice a high level of integrity, honesty, and in maintaining confidentiality

Benefits

• •BENEFITS (Full-Time)
• •Competitive salary
• •Health Insurance
• •Dental Insurance
• •Disability Insurance
• •Life Insurance
• •Paid Time Off
• •Vision Insurance

Responsibilities

• •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
• •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