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The Clinical Research Assistant is responsible for: Assisting with multiple research protocols and completing administrative duties on several projects within the center. Recruiting and scheduling patient appointments, including visiting participating clinics for recruitment efforts. Conducting recruitment interviews and consenting participants into studies. Collecting demographic and relevant information, and maintaining and updating patient and research databases. Assisting the team during research visits as needed. Assisting in the operations and maintenance of the biorepository, including processing of samples, storage, transport, and shipment of lab samples and tracking. Performing general laboratory maintenance and assisting with equipment maintenance. Assisting with Institutional Review Board (IRB) requirements, including drafting consent forms, reviewing study protocols to prepare written applications/reports to the IRB, and ensuring protocols meet regulatory rules and guidelines. Reviewing and verifying site regulatory files and assisting with monitoring visits. Providing administrative support to the director and investigators of the MASLD research center. Completing other tasks as directed.
Job Responsibility:
Assisting with multiple research protocols and completing administrative duties on several projects within the center
Recruiting and scheduling patient appointments, including visiting participating clinics for recruitment efforts
Conducting recruitment interviews and consenting participants into studies
Collecting demographic and relevant information, and maintaining and updating patient and research databases
Assisting the team during research visits as needed
Assisting in the operations and maintenance of the biorepository, including processing of samples, storage, transport, and shipment of lab samples and tracking
Performing general laboratory maintenance and assisting with equipment maintenance
Assisting with Institutional Review Board (IRB) requirements, including drafting consent forms, reviewing study protocols to prepare written applications/reports to the IRB, and ensuring protocols meet regulatory rules and guidelines
Reviewing and verifying site regulatory files and assisting with monitoring visits
Providing administrative support to the director and investigators of the MASLD research center
Completing other tasks as directed
Requirements:
Bilingual English/Spanish
Experience with EPIC
Theoretical knowledge of biology, microbiology, social sciences, clinical sciences as typically attained by a Bachelor's degree, or an equivalent combination of education and experience
Experience performing clinical research duties in a clinical research environment
Experience using statistical software applications. Knowledge of database, word processing and spreadsheet applications such as Velos, Access, Excel and MS Word
Experience with laboratory procedures and values and experience in interpreting them to determine patient eligibility and potential toxicities
Experience working with FDA policies regulating clinical trials
Experience in medical assessment and patient interviewing to determine toxicities related to protocol management
Experience interpreting medical charts, experience in abstracting data from medical records
Knowledge of National Institute of Health (NIH), Good Clinical Practice (GCP), Injury and Illness Prevention Program (IIPP), Human Resource Protection Program (HRPP), IATA Shipping of Blood Specimens, and Bloodborne Pathogens
Experience with clinical trials participant or study subject recruitment
Experience coordinating study startup activities
Experience maintaining files and keeping records
Excellent planning and organizational skills and ability to work in a changing, multiple-demand setting in order to prioritize a large volume of work and meet deadlines efficiently and accurately
Excellent interpersonal, as well as written and verbal communication skills (using grammatically correct written English and accurate typing) to interact with a diverse population. Excellent phone etiquette skills
Ability to work independently. Ability to maintain confidentiality
Experience completing clinical trials case report forms via hard copy and online
Demonstrated ability to interact effectively with diverse groups, including professional and non-professional staff and clients.