Job Summary

The Clinical Research Coordinator (CRC) manages and oversees clinical research data and documentation, including regulatory and patient records. The CRC performs various clinical procedures and supports daily workload management by collecting, recording, reporting, and interpreting data for patients participating in clinical studies, adhering to protocols, SOPs, and GCPs.

Responsibilities

- Support investigators in preparing and executing research studies by:

- Collecting, recording, and maintaining study data per protocols and SOPs, ensuring high standards of content, accuracy, and completeness.

- Submitting regulatory and ethics documentation as required by the FDA and other regulatory bodies.

- Recruiting and screening participants for clinical trials and keeping accurate subject screening logs.

- Assisting with the consent process by informing research subjects about the study's purpose, procedures, and process.

- Maintaining source documentation as per protocol requirements.

- Scheduling and conducting study visits and procedures.

- Handling lab tests, including specimen preparation, shipment, and logistics.

- Monitoring subject safety and reporting adverse events to the Principal Investigator or appropriate medical personnel.

- Communicating with research subjects and resolving study-related issues.

- Participating in team meetings to ensure daily tasks are assigned and completed to standard.

- Assisting with data quality checks and resolving queries.

- Performing various clinical procedures such as ECGs, sample collection, spirometry, vital signs, dose verification, cannulation, and cardiac telemetry monitoring as needed.

- Helping ensure study objectives are met on time and within budget while adhering to protocol, regulatory requirements, and quality standards.

- Training new site staff on study-specific topics and maintaining staff training records.

- Preparing for and attending study monitoring visits, audits, and regulatory inspections.

- Assisting with staffing and scheduling for research studies.

- Maintaining confidentiality of data and PHI.

- Collaborating with provider offices to streamline research workflows.

- Keeping track of study supplies as per protocol.

- Performing other duties and projects as assigned.

Qualifications

- Bachelor’s degree in a related field.

- 1-3+ years of clinical research experience.

- Relevant experience in a clinical or medical setting (e.g., medical assistant, nurse assistant, laboratory technician) or an equivalent combination of education, training, and experience.

- Proficiency in Microsoft Office applications.

- Understanding of medical terminology.

- Working knowledge of clinical trials.

- Familiarity with GCP/ICH and FDA regulations and guidelines for human subject protection.

- In-depth knowledge of departmental, protocol, and study-specific procedures, consent forms, and schedules.

- Ability to perform clinical procedures such as phlebotomy and taking vital signs.

- Strong written and verbal communication skills.

- Skill in applying research principles and techniques to patient care.

- Ability to prepare and maintain records, write reports, and handle correspondence.

- High attention to quality control standards.

- Ability to remain calm and effective in various situations.

- Excellent organizational and problem-solving skills.

- Effective time management with the ability to handle multiple tasks and prioritize with attention to detail.

- Capability to establish and maintain effective working relationships with colleagues, physicians, managers, and clients.

- Commitment to integrity, honesty, and confidentiality.