Job 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

• 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.

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