CLINICAL TRIALS TECHNICIAN

Description:

JOB TITLE: Clinical Trial Technician

JOB SUMMARY: Coordinate and participate in clinical research studies conducted by principal investigators at Nebraska Hematology-Oncology, PC, performing clinical trial patient specific procedures including phlebotomy, specimen processing, electrocardiograms, and vital signs across multiple studies in accordance to appropriate regulations, Standard Operating Procedures, and study specific protocols/manuals.   

TYPICAL PHYSICAL DEMANDS: Requires full range of motion including manual and finger dexterity and eye-hand coordination. Frequent standing and walking required for extended periods of time. Lifts and carries items weighing up to 50 pounds. Requires visual acuity and normal color perception.

REPORTS TO: Clinical Trials Manager

EDUCATION/EXPERIENCE: At least 1 year of experience as a phlebotomist. Clinical research experience in the collection and processing of lab samples, EKGs, vital signs preferred. 

 

DUTIES/RESPONSIBILITIES:

• Perform clinical trial procedures for clinical research studies conducted by principal investigator(s) at Nebraska Hematology-Oncology, PC. 
• Participate in study initiation visits, source document creation/review, planning for cross-departmental procedures (such as with laboratory and sample collection from vascular access devices)  
• Confirm study visit lab orders are accurate in preparation for visit 
• Ensure billing compliance for study-related lab testing
• Perform study lab collection including phlebotomy, lab sample processing, storage, packaging and shipment across multiple studies simultaneously   
• Perform vital signs collection and electrocardiograms in collaboration with clinical trials coordinators
• Assess/facilitate study-specific patient reported outcomes/diary compliance in collaboration with clinical trials coordinators
• Assure compliance of general and study specific processes with SOPs, the FDA, and applicable regulatory agencies. 
• Perform other related duties incidental to the work described herein. 
• Perform phlebotomy if/as needed for routine patient care 

Requirements:

REQUIRED SKILLS/ABILITIES:

• Applicant should be detail-oriented with excellent communication skills. 
• Position will require interaction with patients, study sponsors, the research team, and principal investigators. 
• Knowledge of organizational policies, regulations, and procedures to administer clinical research protocols.  
• Knowledge of medical terminology.  
• Knowledge of common safety hazards and precautions to establish a safe work environment.  
• Skill in identifying problems and recommending solutions.  
• Skill in preparing and maintaining records, writing reports, and responding to correspondence.  
• Skill in developing and maintaining department quality assurance.  
• Skill in establishing and maintaining effective working relationships with patients, medical staff, and the public.  
• Ability to maintain quality control standards.  
• Ability to react calmly and effectively in emergency situations. 
• Ability to interpret, adapt, and apply guidelines and procedures. 
• Ability to communicate clearly.  
• Knowledge of safety requirements and ability to recognize and correct hazardous conditions.