JVT Advisors

Clinical Research Assistant (Virginia)

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Location: , Virginia
Employment Type: Contract

Job Description

Contract Length: 3 Months

Job Summary: Candidate will be working in clinic to enroll patients in Genomic studies. Approach patients for consent and educate them on genetics study. Will need strong communication, listening and conversation skills. Engage patients to get involved and get them signed up. Need Data entry skills, using Tablet and Red Cap program. Will support multiple clinics within 25 mile radius and will pay standard mileage. Shift is 8 hours a day M-F but can be flexible on start time, 5am, 7am, or 3pm. Could also work Saturday if needed to offset M-F.

 

Responsibilities:

• Adheres to Standard Operating Procedures (SOP), GCP, all regulatory practices as established by law, and company policies and procedures
• Provides assistance to research staff by organizing files, project information, and data
• Assists with collecting training forms, collection and/or preparation of essential documents, and obtaining required signatures from all applicable research personnel for regulatory/essential documents throughout the duration of a study including, but not limited to, Form Food and Drug Administration (FDA) 1572, Curriculum Vitae (CV), professional licensure, financial disclosure forms (FDF) and Institutional Review Board (IRB) submission forms
• Understands protocol specific key inclusion/exclusion criteria to assist pre-screening efforts
• Completes sponsor-specific logs, timely updates of subject information, diagnosis, and study subject status in the clinical trial management system (CTMS)
• Maintains all research-specific temperature logs
• Acquires dry ice for shipping laboratory specimens
• Files and maintains all research-specific regulatory documents
• Prints and certifies research-specific medical records per established guidelines
• Trains under the guidance of direct supervisor and other site personnel to promote participation in research studies including mail-outs and other marketing programs as applicable
• Ensures research subject’s referring and/or primary care physician receives notification of subject’s participation in studies as requested by the subject
• Assists with general managed site projects and workload-sharing as assigned by direct supervisor
• Develops an understanding of the regulations governing clinical research by obtaining and maintaining GCP certification and Human Subjects Research Training certification
• Develops an understanding of the regulations governing the transport of human specimens by obtaining and maintaining International Air Transport Association (IATA) certificate
• Become familiar with study protocols by attending training where possible, or self-review
• Prepares research site team for research subject visits, including but not limited to printing source document worksheets, preparing laboratory sampling kits, and completing subject reminder calls daily or as applicable
• Utilizes the Slope Inventory System to maintain study specific laboratory supplies and identify quantity and expiration dates; subsequently orders supplies from sponsor vendors as needed
• Prepares, processes, and ships study-specific laboratory specimens per protocol and IATA requirements
• Ensures laboratory and other local and central results are given to the appropriate investigators for review of clinical significance in a timely manner; files signed results in appropriate location
• Performs timely and accurate data entry of study-specific data into electronic case report forms (eCRF)
• Update site’s CTMS with accurate data entry daily
• Assists direct supervisor or other site personnel with routine quality assurance verification following the Site Quality Assurance Working Practice Guideline (WPG)
• Assists with preparation for monitoring visits, study close-out visits, and audits as required
• Attends clinical research-related training as required: 2

• Ensures completion and collection of Form W9 from new research subjects
• Requests new vendor information following CCPay WPG
• Ensures stipends are assigned to each research subject’s study visits in CTMS

Requirements:

• High School Diploma required
• Certified Medical Assistant preferred

• 0-2 year experience in a medical setting and/or clinical research setting preferred
• Attention to detail
• Willingness to obtain research specific training as needed
• Ability to meet deadlines for multiple concurrent projects
• Ability to understand and follow study-specific protocol guidelines
• Ability to understand and comply with direction provided by PI, direct supervisor, and other site and Frenova personnel
• Ability to understand the complexities of a patient medical record
• Proficient with different types of technology and Microsoft Office applications
• Strong communication skills, verbal and written
• Strong organization skills

Brian Potts

Recruiter

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