TECH CHARGE ADVANCED

Description

PM CHARGE POSITION

Job Summary:

Responsible for advanced technical procedures (such as, but not limited to, meal administration, subject positioning, bag check, vital signs, ECG lead placement, phlebotomy, urine collection, PK runner, height/weight/BMI, dose verification) in the conduct of clinical trials with emphasis on the safety and welfare of study participants.  Performs the practical activities of clinical studies according to protocol, regulatory requirements, SOPs, scope of practice and current training status.

Essential Duties and Responsibilities:              

• With supervision, ensures that clinical trials are conducted according to protocol requirements by utilizing the following techniques & procedures.
• Performs meal administration, ensuring the correct meal and correct content is delivered to the correct study participant.
• Performs subject bag checks to ensure no contraband is present on study floor
• Performs study activities such as ECG positioning, exercises, or other study procedures requiring supervision of subjects.
• Performs venipuncture, capillary, and/or IV specimens from study subjects according to established protocol, maintains aseptic technique.
• Performs proper and accurate sample management, including collection, identification, transport, and/or processing of biological (blood, urine, etc) subject samples.
• Performs dose verification, assisting Clinical Research Nurses during dose administration to accurately verify subject identity and dosing labeling, as additional quality check.
• Report any subject complaints of adverse events immediately to Charge staff or Clinical Research Nurses to ensure appropriate evaluation and treatment.
• Performs and records physical measurements including height, weight, and BMI calculation.
• Performs and records vital sign measurements (blood pressure, pulse oximetry, heartrate, temperature, respirations, etc).
• Places ECG electrodes and leads accurately to ensure precise telemetry monitoring.
• Performs additional task list items as delegated and supervised by Charge Staff.
• Reviews Study Specific Trainings and applicable protocols for a thorough understanding of the study procedures, as they apply to their role and ensures that Delegation of Authority/Training Log for each study is completed in a proper and timely manner.
• Keeps abreast of SOPs, Good Clinical Practice (GCP) and ICH guidelines, state and national laws and ethical standards.
• Observes and maintains all HIPAA, OSHA, and Exposure Control regulations and Emergency Response as required by applicable training.
• Creates and maintains accurate records of all protocol activities and events, as delegated and trained.
• Follows progress of volunteers and provides for their care, comfort and safety by attending to their needs during study participation.
• Participates in quality assurance of clinical research projects and initiates the need for same as it impacts on clinical practice.

The Statements made in the job description are intended to describe the general nature and level of work being performed by people assigned to this job.  These statements are not intended to be an exhaustive list of all responsibilities, duties and skills required of people assigned to this job.

Skills/Qualifications              

• Ability to read, write and interpret the English language.
• Portrays professionalism in all interactions at Spaulding Clinical.
• Good computer skills; inclination to adopt technology to maximize efficiency
• Demonstrates strong analytical, problem solving skills
• Strong written and verbal communication skills.
• Detail oriented, good organizational traits.
• Self-motivated
• Must be results-oriented, multi-tasking, quick learner, respond to the urgent needs of the team, and show a strong track record of meeting deadlines.
• Ability to work beyond normal work hours and various shift availability required.
• Ability to perform and record data entry via computer systems while conducting timed clinical procedures.

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Ability to sit, stand, walk, reach with hands and arms, and use hands along with fingers, to handle or feel.
• Ability to lift and/or move up to 25 pounds.
• Specific vision abilities required by this job include clarity of vision both near and far. 
• Ability to identify and distinguish colors.

Hazards:

• Potential for exposure to toxic or caustic chemicals
• Potential for exposure to blood borne pathogens

Education and Experience:

• Associate's Degree in a scientific/medical discipline desirable
• Phlebotomy Certificate or associated real-world (on-the-job training) experience required
• Certified Nursing Assistant or Medical Assistant certification highly desirable
• BLS certification required within 6 months of hire or promotion date.

 Spaulding Clinical Research management has the discretion to hire personnel with a combination of experience and education which may vary from the above listed skills and qualifications.

CHARGE SPECIFIC

Job Summary:

Essential Duties and Responsibilities:              

• Keeps abreast of SOP’s, ICH/GCP guidelines, NIH guidelines, as well as state and national regulatory requirements.

Maintains calm, professional atmosphere on study floor, leading by example with professional resolution of conflict and appropriate delegation.

• Ensures that Study Manager and Clinical Floor Supervisors are updated and escalates study related issues that arise on the study floors with urgency, if needed.  Communicates all other issues as warranted to the appropriate department. 
• Records subjects Adverse Events with proper documentation and treatment as warranted and escalates to medical personnel or project management as appropriate.
• Administers oral study drug, while accurately ensuring the 5 Rights of Medication Administration (the right subject, the right drug, the right dose, the right route, and the right time)
• Performs dose verification, assisting other dosers during dose administration to accurately verify subject identity and dosing labeling, as additional quality check.
• Contributes and is accountable for secure and appropriate storage of all drug supplies after removing from pharmacy.
• Ensures all shift duties are completed according to Charge Checklist or equivalent, including completion of all applicable logs and metrics.
• Works with colleagues to achieve departmental goals as delegated.
• Maintains knowledge of company goals to assist all floor staff in their development and engagement.
• Maintains a clean, quiet study environment in all study areas.
• Works with Training Department to perform and document Process Monitoring to ensure staff compliance and adherence.

The Statements made in the job description are intended to describe the general nature and level of work being performed by people assigned to this job.  These statements are not intended to be an exhaustive list of all responsibilities, duties and skills required of people assigned to this job.

Skills/Qualifications:              

• Ability to read, write, and interpret the English language.
• Must show ability to stay up-to-date on all available trainings.
• Excellent time management skills.
• Demonstrates strong analytical and problem solving skills.
• Demonstrates effective leadership traits with ability to direct and delegate.
• Portrays professionalism in all interactions at Spaulding Clinical.
• Strong written and verbal communication skills.
• Self-motivated.
• Must be reliable and responsible for attending scheduled shifts, along with flexibility for higher study activity demands.
• Must be results oriented, proficient at multi-tasking, quick learner, organized, responsive to the urgent needs of the team and show a strong track record of meeting deadlines.
• Proficient computer skills; inclination to adopt technology to maximize efficiency.
• Strong attention to detail.
• Demonstrates ability to adapt to a rapidly changing study environment.

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Ability to sit, stand, walk, reach with hands and arms, and use hands along with fingers, to handle or feel.
• Ability to lift and/or move up to 25 pounds.
• Specific vision abilities required by this job include clarity of vision both near and far. 
• Ability to identify and distinguish colors.

Hazards:

• Potential for exposure to toxic or caustic chemicals
• Potential for exposure to blood borne pathogens

Education and Experience:

 Spaulding Clinical Research management has the discretion to hire personnel with a combination of experience and education which may vary from the above listed skills and qualifications.

Qualifications