Job Description

　　Overnight position

　　Summarized Purpose: Supports the Clinic in the overall conduct of multiple, ongoing clinical trials involving an in-patient setting, ensuring patient safety and cooperation during the study process.

　　Essential Functions

　　• Reviews inclusion/exclusion criteria with patients to ensure eligibility to participate in study. Interacts with Principal Investigator for inclusion/exclusion review of patient data. Reviews and witnesses the consenting process for subjects. Prepares study-specific documents for applicable study visit.

　　• Ensures the safety of patients by monitoring and assessing AEs, if any, and communicating potentially serious findings to investigators.

　　• Performs all procedures in the treatment areas (i.e., check-ins, gauze management, administration of drug, blood draws, ECGs, vital signs, etc.). Monitors staff to assure adherence to GCP, ICH, FDA, and OSHA guidelines.

　　• Attends initiation meetings when necessary to obtain study process clarification.

　　• Monitors and continuously evaluates the overall research experience of each patient to assure a positive experience.

　　• Performs other study-related duties as qualified by documented training.

　　Job Complexity: Works on difficult or complex assignments requiring considerable judgment and initiative to resolve issues. Understands implications of work and makes recommendations for solutions and / or new procedures.

　　Job Knowledge: As a skilled or highly skilled specialist, completes tasks in resourceful and / or creative ways, and may contribute to the development of concepts and techniques.

　　Supervision Received: May act independently on determining methods and procedures on new assignments. May be a facilitator and / or team leader (formal or informal).

　　Business Relationships: Contacts are frequent with individuals representing outside organizations, and / or individuals of significant importance within the company. Contacts involve planning and preparation of communications, requiring skill, tact, persuasion and / or negotiation to accomplish the objectives of the communication.

　　Qualifications

　　Education and Experience Nurses:

　　ADN from an accredited institution/active RN or LVN licence to practice1 year experience as RN or LVNTechnical positions may require a certificatePrevious experience that provides the knowledge, skills, and abilities to perform the job (comparable to at least 6 years). Bachelors degree preferred.Telemetry

　　Education and Experience for Paramedics:

　　High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification.Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to at least 4 years which should include 3 years experience as a Paramedic on an ALS unit and/or in a clinical setting). Florida Licensed/Certified EMT-Paramedic and American Heart Association Advanced Cardiac Life Support (ACLS) certification required.

　　In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

　　Knowledge, Skills and Abilities:

　　• Ability to work well in a team environment and interact with all levels of staff, clients, and subjects in a positive and professional manner

　　• Strong planning and organizational capabilities to manage multiple tasks and study groups at one time

　　• Basic computer skills, good handwriting and attention to detail

　　• Willingness and ability to administer investigational drugs or test investigational devices intravenously, topically, or by other approved methods of dosing

　　• Willingness and ability to learn and perform a variety of technical procedures such as drawing blood, processing and harvesting lab specimens, taking vital signs, performing ECGs, etc.

　　• Excellent verbal and written communication skills. • Ability to respond to medical emergency scenarios, in accordance with ACLS guidance, established emergency protocols, and Investigator instructions

　　Management Role: No management responsibility

　　Working Conditions and Environment:

　　• Work is performed in an office or clinical environment with exposure to electrical office equipment

　　• Occasional drives to site locations. Potential Occasional travel required

　　• Frequent long hours, weekends and/or holidays

　　• Exposure to blood and biohazardous waste

　　• Be available by cell phone after hours

　　• Exposure to fluctuating and/or extreme temperatures on rare occasions

　　Physical Requirements:

　　• Frequently stationary for 4-6 hours per day.

　　• Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.

　　• Frequent mobility required.

　　• Occasional crouching, stooping, bending and twisting of upper body and neck.

　　• Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.

　　• Ability to access and use a variety of computer software developed both in-house and off-the-shelf.

　　• Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences.

　　• May interact with others, relating and gathering sensitive information. Interaction includes diverse groups.

　　• Works with guidance or reliance on oral or written instructions from management. May require periods of intense concentration.

　　• Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task.

　　• Regular and consistent attendance.

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