Clinical Research Assistant

at  Dermcare Management Llc

Clinical Research Assistant will perform work in one or all of the following areas Phlebotomy, Data Entry, and Administrative Assistant responsibilities in support of the clinical research team. The Clinical Research Assistant will assist in the management of multiple clinical trials according to the study protocol, perform collection of clinical data points, and provide seamless customer service to the patients attending the site.

Responsibilities Include but not limited to:

• Complete training and ensure adherence of GCPs, SOPs, IATA, and HIPPA
• Ensure compliance with all clinical trial protocols
• Ensure compliance with Standard Operating Procedures (SOP), principles of Good Clinical Practice (GCP) and applicable federal, state, and local regulations through OSHA, CDC, and HIPPA.
• Assist research staff with Phase II-IV clinical trials from start through closure
• Enter visits, patient recruitment in Real Time Clinical Trial Management System (CTMS)
• Aid research department is meeting contracted and expected recruitment goals
• Engage in quality assurance of all study documents and data prior to monitoring visits
• Support central and local marketing campaigns by entering recruitment data, contacting patients and scheduling.
• Coordinate office visits for trial participants based on the protocol
• Perform phlebotomy, collect, process and ship clinical specimens
• Assist in patient care visits and procedures according to protocol
• Receive medication, confirm temperature in range and maintain temperature logs
• Perform ECGs
• Engage in patient recruitment
• Assist with entry into Electronic Data Capture (EDC) data queries are resolved
• Participate in Investigator meetings and trainings during the course of the trial
• Generate PowerPoint presentations
• Create and organize new patient charts, lab and other required supplies prior to the patient visit.
• Gain access to Institutional Review Boards.
• Maintain regulatory binders, CRFs, subject charting, and source documents
• Maintain the Investigator Site Files
• Assist with keeping Institutional Review Boards (IRB) documents, Electronic Data Capture (EDC) Clinical Trials Management System (CTMS) and Interactive Web Response Systems (IWRS) current
• Will support central and local marketing campaigns by contacting potential subjects and scheduling
• Possess a minimum of two (2) years experience in the clinical research or closely related field
• Bachelors degree or relevant work experience.
• Bilingual (Spanish), a plus.

• Complete training and ensure adherence of GCPs, SOPs, IATA, and HIPPA
• Ensure compliance with all clinical trial protocols
• Ensure compliance with Standard Operating Procedures (SOP), principles of Good Clinical Practice (GCP) and applicable federal, state, and local regulations through OSHA, CDC, and HIPPA.
• Assist research staff with Phase II-IV clinical trials from start through closure
• Enter visits, patient recruitment in Real Time Clinical Trial Management System (CTMS)
• Aid research department is meeting contracted and expected recruitment goals
• Engage in quality assurance of all study documents and data prior to monitoring visits
• Support central and local marketing campaigns by entering recruitment data, contacting patients and scheduling.
• Coordinate office visits for trial participants based on the protocol
• Perform phlebotomy, collect, process and ship clinical specimens
• Assist in patient care visits and procedures according to protocol
• Receive medication, confirm temperature in range and maintain temperature logs
• Perform ECGs
• Engage in patient recruitment
• Assist with entry into Electronic Data Capture (EDC) data queries are resolved
• Participate in Investigator meetings and trainings during the course of the trial
• Generate PowerPoint presentations
• Create and organize new patient charts, lab and other required supplies prior to the patient visit.
• Gain access to Institutional Review Boards.
• Maintain regulatory binders, CRFs, subject charting, and source documents
• Maintain the Investigator Site Files
• Assist with keeping Institutional Review Boards (IRB) documents, Electronic Data Capture (EDC) Clinical Trials Management System (CTMS) and Interactive Web Response Systems (IWRS) current
• Will support central and local marketing campaigns by contacting potential subjects and scheduling
• Possess a minimum of two (2) years experience in the clinical research or closely related field
• Bachelors degree or relevant work experience.
• Bilingual (Spanish), a plus