Research Assistant

Research Assistant Care United Research Forney, TX Job Details Full-time From $21 an hour 1 hour ago Benefits Health insurance Dental insurance Paid time off Vision insurance Qualifications Spanish Clinical research Laboratory experience English Administrative experience Clerical experience Full Job Description About the

Position:

The Clinical Research Assistant is responsible for assisting all positions at Care United Research with managing the daily operations of multiple sponsored diagnostic, device or drug clinical trials Phases II through IV.

Primary Job Responsibilities:

Administrative & Clinical Participate in and assist with the day-to-day functions at Care United Research

• Utilizes a team approach with all members of the research team Administrative support for all research staff such as but not limited to mailing, scanning, faxing, copying, renaming/organizing electronic files Establishes, develops, organizes, maintains and updates filing system(s) accordingly such as one drive and regulatory files both paper and electronic Assist with supplies/kit ordering and for research office supplies & research trial activity Complete any tasks/assignments assigned by Research Director/Medical Director Answer and direct phone calls accordingly Greet and communicate with visitors, patients, vendors in a professional and friendly manner Handle confidential and non-routine information Attend staff meetings and sponsor/CRO meetings, which are all dependent of the PI schedule Patient triaging such as collecting medical history and concomitant medications Maintains a detailed knowledge of study protocol(s) in-order-to complete all study activities accurately and completely • Maintains an ongoing understanding of the indications under investigation Continuously monitor all patients who have checked in the clinic via the patient tracker system to assist with recruitment for current enrolling trials • Conducts pre-screening/chart review activities for assigned trials • Recruits patients in exam rooms multiple times a day or daily over the phone • Completes scheduled subject visits such as screens, and retains patients for clinical trials • Performs comprehensive medical history and data reviews to ensure proper enrollment and randomization of qualified subjects per the inclusion / exclusion criteria • Provides instructions and education to subjects to ensure proper protocol compliance, drug compliance and diary compliance • Ensures that all laboratory samples are collected and processed per the trial lab manual • Mindful of time frames for lab specimen shipping per trial to ensure stability is kept • Ensures all laboratory reports are printed/prepped for the PI within 24 hours from being generated • Ensures patients are updated with PI's instructions of medical care within same day of PI assessment • Distributes study test articles per the protocol requirements and Investigator instructions and maintain complete and accurate test article accountability records • Updates the Investigator of all patient progress, adverse events, non-compliance, and safety issues throughout the duration of the clinical trial • Reports all serious adverse events to the Medical Director, Sponsor and IRB in compliance with FDA regulations and sponsor requirements • Provides the Sponsor with accurate and complete documentation and information • Completes and maintains accurate, legible and complete source documents and case report forms per FDA guidelines and Sponsor requirements • Forwards/updates all team members of sponsor correspondence and updated forms • Inform sponsor of prospective FDA audits immediately • Prepares for FDA audits by ensuring all documentation and case report forms are available and complete.

Ensure the rights, safety and welfare of all subjects at all times

• Ensures that each subject has gone through the informed consent process following GCP guidelines, and consented to participate, before any study related procedures are performed
• Provides subject education on an ongoing basis throughout their participation in the protocol
• Enters all patients weekly, in a complete, accurate, and timely manner, in the appropriate database
• Assists in the training of new and current staff members on protocols and delegated role/job requirements
• Acts as a liaison to ensure complete and accurate communication between physicians, sponsors and subjects via in person, phone call or email
• Work in a collaborative, effective manner with the Sponsor personnel to meet research objectives completely and accurately
• Understands all internal policies and site practices, and Standard Operating Procedures approved by the

Medical Director/Research Director Qualifications and Certifications:

• Bachelor's Degree (BA/BS) with a scientific or education focus
• Proficiency in Microsoft Outlook, Word, Excel and PowerPoint
• An interest in pursuing career in the scientific, healthcare/medical field
• Previous administrative assistance required
• Bilingual (English and Spanish speaking) required Previous experience with vitals collection (blood pressure, respiratory rate, heart rate) required
• 1-2 years of clinical research experience is preferred, but not required
• Certifications for GCP, Human subject protection and IATA, will be required, but can be completed at the time of hire
• Phlebotomy experience preferred, but not required
• EKG experience preferred but not required

Mental Requirements:

• Ability to work well under pressure with diverse groups of professionals and physicians
• Requires reasoning ability and good independent judgment
• Must be sensitive to cultural and bilingual issues
• Requires working under stressful conditions
• Requires working with frequent interruptions

Job Type:

Full-time Pay:

From $21.00 per hour

Benefits:

Dental insurance Health insurance Paid time off Vision insurance

Medical Specialty:

Allergy & Immunology Cardiology Endocrinology Gastroenterology Infectious Disease Neurology Physical Setting:

Clinic Work Location:

In person