Clinical Research Coordinator

**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** - 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…