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

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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