Phlebotomist

Job Summary

The Clinical Research Coordinator (CRC)/Phlebotomist manages and oversees clinical research data and documentation, including regulatory and patient records. The CRC/Phlebotomist 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.

- 1-2 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.