Posted : Wednesday, September 04, 2024 02:37 PM
*Position Title*
Clinical Research Coordinator
*Salary Range*
$18-25/hr, based on experience
*Schedule*
Full-time Non-Exempt Status
Approximate Hours: Mon-Fri 7:00 am – 3:00 pm \*Flexibility\*
Professional meetings according to scheduled times
*Required Qualifications*
Bilingual (English, Vietnamese)
Required Training
· Certifications may be completed upon employment
· CITI GCP – 3-year renewal
· IATA/Hazardous shipping – 2-year renewal
· Infection control/ Blood Borne Pathogens – annual renewal
· Bachelor’s Degree or higher
· Prior experience in a patient care role such as a medical scribe, medical assistant (MA), LVN, or RN.
· Experience in diabetes and endocrinology or cardiology is a strong plus.
· Phlebotomy experience (1+year).
· Ability to learn and become proficient with industry software and computer applications.
· Skill and proficiency in verbal and written communication, analytical thinking, problem-solving, and multitasking.
· Ability to work independently in a fast-paced environment with minimal supervision and multiple ongoing priorities.
· Possess a positive, friendly, and professional demeanor.
· Proficiency with Microsoft Office.
*Reports to* · Clinical Research Director/CEO · Lead Research Coordinator *Duties/Responsibilities* · Performs all clinical research duties within regulatory compliance and industry guidelines as described in the Food and Drug Administration (FDA), Good Clinical Practices (GCP), International Conference on Harmonization (ICH), Health Insurance Portability and Accountability Act (HIPPA), institutional review boards (IRB), TVCR policies and standard operating procedures (SOP), and sponsor requirements.
· Understand the importance of maintaining research subject confidentially throughout the duration and upon completion of a trial.
· Create study-specific source document based on sponsor-provided study protocol.
· Perform timely data entry and documentation of completed study-directed assessments.
· Recruit and schedule new patients for study screening contacted through advertisement campaigns or physician referrals.
· Conduct and capture documentation of study-directed assessments with study subjects outlined in each study protocol, including but not limited to recording subject history, obtaining and reviewing medical records, collecting vital signs, performing phlebotomy and informed consent, reviewing adverse events, and subject health assessments.
· Obtain, process, and ship study lab specimens (blood, saliva, urine) for analysis, if needed.
· Resolve sponsor-initiated data management queries promptly.
· Assist in preparing source evaluation by sponsor monitors and provide monitor assistance/ feedback.
· Communicate effectively with study subjects about scheduling, appointment reminders, review of study procedure results, and relaying information from the principal investigator to the subject.
· Communicate via email or in person with internal and external personnel such as physicians, nurses, administration staff, industry sponsor representatives, central laboratory and imaging personnel, and study subjects.
· Perform new duties that arise due to changing clinic needs.
· Ensure investigational product/study medication is stored and managed correctly.
· Ensure compliance with sponsor study-specific manuals and guides.
· Ensure study supplies are on-site when required and manage inventory.
· Ensure all screening, enrollment, and randomization logs are kept current.
· Light office cleaning duties.
*Work Environment and Physical Demands* · The work environment and physical demands described here represent those that an employee must meet to successfully perform the essential functions of this job.
· Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
· Work is performed in an office/laboratory and a clinical environment.
· Exposure to biological fluids and bloodborne pathogens.
· Personal protective equipment may be required, such as protective eyewear, garments, and gloves.
· Ability to work upright and stationary for 6-10 hours daily.
· Frequent mobility required to include occasional squatting, kneeling, or bending.
· Light to moderate lifting and carrying (or otherwise moving) objects, including medical equipment, with a maximum lift of 20-50 lbs.
This job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee.
Duties, responsibilities, and activities may change, or new ones may be assigned at any time, with or without notice, as the clinic needs to change and grow.
Job Type: Full-time Pay: $18.
00 - $25.
00 per hour Expected hours: 30 – 50 per week Benefits: * Flexible schedule * Paid time off Experience level: * 1 year * 2 years * 3 years * 4 years * 5 years * No experience needed * Under 1 year Medical specialties: * Endocrinology Schedule: * 4 hour shift * 8 hour shift * Weekends as needed Language: * Vietnamese (Required) Work Location: In person
· Experience in diabetes and endocrinology or cardiology is a strong plus.
· Phlebotomy experience (1+year).
· Ability to learn and become proficient with industry software and computer applications.
· Skill and proficiency in verbal and written communication, analytical thinking, problem-solving, and multitasking.
· Ability to work independently in a fast-paced environment with minimal supervision and multiple ongoing priorities.
· Possess a positive, friendly, and professional demeanor.
· Proficiency with Microsoft Office.
*Reports to* · Clinical Research Director/CEO · Lead Research Coordinator *Duties/Responsibilities* · Performs all clinical research duties within regulatory compliance and industry guidelines as described in the Food and Drug Administration (FDA), Good Clinical Practices (GCP), International Conference on Harmonization (ICH), Health Insurance Portability and Accountability Act (HIPPA), institutional review boards (IRB), TVCR policies and standard operating procedures (SOP), and sponsor requirements.
· Understand the importance of maintaining research subject confidentially throughout the duration and upon completion of a trial.
· Create study-specific source document based on sponsor-provided study protocol.
· Perform timely data entry and documentation of completed study-directed assessments.
· Recruit and schedule new patients for study screening contacted through advertisement campaigns or physician referrals.
· Conduct and capture documentation of study-directed assessments with study subjects outlined in each study protocol, including but not limited to recording subject history, obtaining and reviewing medical records, collecting vital signs, performing phlebotomy and informed consent, reviewing adverse events, and subject health assessments.
· Obtain, process, and ship study lab specimens (blood, saliva, urine) for analysis, if needed.
· Resolve sponsor-initiated data management queries promptly.
· Assist in preparing source evaluation by sponsor monitors and provide monitor assistance/ feedback.
· Communicate effectively with study subjects about scheduling, appointment reminders, review of study procedure results, and relaying information from the principal investigator to the subject.
· Communicate via email or in person with internal and external personnel such as physicians, nurses, administration staff, industry sponsor representatives, central laboratory and imaging personnel, and study subjects.
· Perform new duties that arise due to changing clinic needs.
· Ensure investigational product/study medication is stored and managed correctly.
· Ensure compliance with sponsor study-specific manuals and guides.
· Ensure study supplies are on-site when required and manage inventory.
· Ensure all screening, enrollment, and randomization logs are kept current.
· Light office cleaning duties.
*Work Environment and Physical Demands* · The work environment and physical demands described here represent those that an employee must meet to successfully perform the essential functions of this job.
· Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
· Work is performed in an office/laboratory and a clinical environment.
· Exposure to biological fluids and bloodborne pathogens.
· Personal protective equipment may be required, such as protective eyewear, garments, and gloves.
· Ability to work upright and stationary for 6-10 hours daily.
· Frequent mobility required to include occasional squatting, kneeling, or bending.
· Light to moderate lifting and carrying (or otherwise moving) objects, including medical equipment, with a maximum lift of 20-50 lbs.
This job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee.
Duties, responsibilities, and activities may change, or new ones may be assigned at any time, with or without notice, as the clinic needs to change and grow.
Job Type: Full-time Pay: $18.
00 - $25.
00 per hour Expected hours: 30 – 50 per week Benefits: * Flexible schedule * Paid time off Experience level: * 1 year * 2 years * 3 years * 4 years * 5 years * No experience needed * Under 1 year Medical specialties: * Endocrinology Schedule: * 4 hour shift * 8 hour shift * Weekends as needed Language: * Vietnamese (Required) Work Location: In person
• Phone : NA
• Location : 4118 Pond Hill Rd Ste 300, Shavano Park, TX
• Post ID: 9127437837