Job Description

The Phlebotomist/Laboratory Technician plays a pivotal role in the successful execution and management of clinical trials, extending their support far beyond traditional laboratory tasks. Their responsibilities ensure the integrity of the research data, the welfare of study participants, and the operational efficiency of the study.  

Responsibilities include: 

Clinical Trial Support 

• Administrative Assistance: Support physicians, research managers, and clinical study staff with study-specific tasks to facilitate smooth operations of clinical trials. 

• Participant Interaction: Consent potential participants, providing them with necessary information regarding the study to make informed decisions. Additionally, gather vital signs, perform electrocardiograms, and ensure accurate documentation of visit assessments and participant eligibility. 

Laboratory and Specimen Management 

• Specimen Handling: Engage in phlebotomy, specimen collection, computer order entry, and specimen processing to guarantee precise test results. 

• Specimen Shipping: Obtain, process, and ship specimens to central laboratories, adhering to proper handling and transportation protocols. 

Data Management and Documentation  

• Record Keeping: Collect and record pertinent assessment details, ensuring the accuracy and confidentiality of all participant-related records. 

• Data Entry and Verification: Assist with the transcription and data entry of Source Documents and Case Report Forms (CRFs) into research management systems, maintaining data integrity and responding to queries in Electronic Data Capture (EDC) systems. 

Compliance and Protocol Adherence  

• Study Protocol Compliance: Ensure that all activities comply with study protocols, standard operating procedures (SOPs), and regulatory requirements to maintain the validity and integrity of the trial. 

• Documentation and Logs: Prepare and maintain essential documents, including visit documentation, study logs, participant binders, and ensure timely filing of study-specific paperwork. 

Logistics and Coordination  

• Visit Preparation: Organize ancillary supplies and documents required for upcoming participant visits. 

• Vendor Coordination: Coordinate the pickup of outgoing packages with appropriate vendors and monitor temperature-controlled study products to ensure their integrity. 

Team and Culture 

• Collaborative Input: Provide professional insights during team discussions and meetings, contributing to the collective decision-making process. 

• Work Culture: Engage actively in creating and maintaining a positive work environment, demonstrating teamwork and flexibility. 

General Duties 

• Miscellaneous Tasks: Perform other related duties as required, including but not limited to organizing incoming faxes, monitoring study product temperatures, and ensuring the daily filing of documents. 

Preferred Qualifications:  

The preferred qualifications for a Laboratory Technician involved in clinical research encompass a mix of educational background, experience, technical skills, certifications, and personal attributes that enable them to perform their duties effectively. Given the comprehensive list of responsibilities, here's a detailed outline of the qualifications that would be ideal for such a role: 

Educational Background  

• Minimum Education: Associate degree in a life science field such as Biology, Chemistry, Biochemistry, or Medical Technology. A Bachelor's degree in one of these fields is highly preferred. 

• Relevant Courses: Coursework that includes biology, chemistry, medical terminology, and possibly pharmacology, depending on the specific focus of the clinical research. 

Experience 

• Clinical Research Experience: Previous experience working in a clinical research setting or a clinical laboratory is highly beneficial. This can range from internships to full-time roles, with a preference for experience in a role that involved direct handling of clinical specimens, data management, and interaction with study participants. IV line experience is beneficial.

• Technical Skills: Hands-on experience with laboratory techniques such as phlebotomy, electrocardiograms (ECGs), specimen processing, and familiarity with laboratory information management systems (LIMS) and electronic data capture (EDC) systems. 

Certifications  

• Clinical Laboratory Certifications: Certifications such as a Certified Phlebotomy Technician (CPT) can be advantageous. 

• Good Clinical Practice (GCP): Training or certification in Good Clinical Practice, which is a standard for clinical trials that involve human participants, ensuring ethical and scientific quality. 

Skills and Competencies  

• Attention to Detail: Ability to perform tasks with precision and accuracy, crucial for data collection, specimen handling, and documentation. 

• Communication Skills: Strong written and verbal communication skills for effectively interacting with study participants, team members, and documenting procedures and results. 

• Organizational Skills: Proficiency in managing multiple tasks simultaneously, organizing study materials, and maintaining accurate records. 

• Computer Proficiency: Comfortable with data entry and the use of databases, spreadsheets, and other software used in clinical research. 

• Interpersonal Skills: Ability to work well in a team, as well as with study participants, displaying sensitivity and professionalism. 

Personal Attributes  

• Ethical Standards: High ethical standards and integrity in handling sensitive health information and adhering to confidentiality requirements. 

• Problem-Solving Abilities: Capable of identifying and resolving issues with specimen handling, data management, or study protocols. 

• Adaptability: Flexible in handling various tasks and adapting to changing priorities or procedures in a dynamic research environment. 

• Interest in Clinical Research: A genuine interest in contributing to medical research and the development of new therapies or treatments. 

Regulatory Knowledge  

• Familiarity with regulatory requirements and standards affecting clinical research, including those set by the FDA, HIPAA for privacy issues, and any relevant local regulations. 

Having a mix of these qualifications will make a candidate well-suited for the role of a Laboratory Technician in a clinical research setting, ensuring they can contribute effectively to the success of clinical trials and research projects. 

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