Description

Clinical Research Assistant

Skin Care Research is looking for a highly motivated Clinical Research Assistant to support the clinical research team. The candidate will be expected to be in compliance with Standard Operating Procedures (SOP), principles of Good Clinical Practice (GCP) and applicable federal, state, and local regulations through OSHA, CDC, and HIPPA. The position requires maintaining 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. Excellent verbal and written skills are required for communication with physicians, staff, patients, monitors, CRO's and sponsors (Pharmaceutical, Biotech and Device manufacturers. The position requires the research assistant to be organized, detail oriented, aid in the development of source documentation. Excellent technical and computer skills (ie Microsoft Office) is a must. The candidate will support central and local marketing campaigns by contacting potential subjects and scheduling. The Research Assistant should have strong phlebotomy, vital sign and ECG skills.

Candidates must have at a minimum of two (2) years experience in the clinical research or closely related field and Bachelor’s degree or relevant work experience. Bilingual (Spanish), a plus.

Responsibilities Include but not limited to:

• Complete training and ensure adherence of GCP’s, SOP’s, IATA, and HIPPA
• Ensure compliance with all clinical trial protocols
• 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 ECG’s
• 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
• Create and organize new patient charts, lab and other required supplies prior to the patient visit.
• Gain access to Institutional Review Boards and print or load docs into portal.
• Maintain regulatory binders (paper & electronic), CRF’s, subject charting, and source documents

Qualifications