Clinical Research Program Manager Jobs in Merton, WI

SPAULDING CLINICAL aims to be the clinical research organization by which all others are measured. Pioneering in our approach to redefining how the industry perceives and achieves success; passionate in our pursuit of ingenious solutions that mitigate risk; loving in our care for our volunteers, customers and employees; and heroic in our ambitions to ensure the health and safety of people around the globe - Spaulding Clinical is taking research beyond results to create a marketplace of safer drugs.    

SPAULDING CLINICAL is looking for a Clinical Research Technician - Advanced to join our AM Team!

Position Snapshot

• Full-time
• Onsite
• Monday – Friday, Hours are between (7am – 3:30pm)
• Ability to work every other holiday rotation and weekend rotation
• Health, Dental, Vision, Life, Long/Short Term Disability, and Supplemental insurance options
• 401k
• Paid Time Off / Holiday Pay

Required Training: Training will begin starting your first two days of New Hire Orientation, which will be a Monday and a Tuesday from 8a-4:30p. Training would continue on Wednesday through Friday 8AM - 4:30PM for your first week. Starting week #2, the training start time may vary between the hours of 6AM and 8AM Monday-Friday, to get signed off on events but are still 8-hour shifts on AM Shift. Training takes a minimum of 8 weeks on this AM schedule before you would switch to your offered shift.

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.