PRN Research Assistant - overnight, weekend, and holidays

About the role

The role of the part time Research Assistant (RA) is to support the clinical staff and patients. This is a part-time clinic-based position. A RA typically performs a variety of administrative tasks in support of clinical trials and assists in the performance of clinical procedures to collect data on patients enrolled and/or seeking enrollment in clinical studies. The RA will assist the Clinical Research Coordinators (CRC)/Research Nurse in the conduct of Phase I-IV industry-sponsored and investigator-initiated clinical trials in accordance with trial protocols FDA Regulations, and ICH/GCP Guidelines.

Responsibilities

• Develop management systems and prepare for study initiation
• Possess a sound and in-depth understanding of each protocol that has been assigned as a primary responsibility
• Review with the Principal Investigator the inclusion/exclusion criteria, overall structure, and requirements of each protocol
• Review the protocol summary sheet and the Informed Consent Form for accuracy and clarity
• Develop draft protocol follow-up worksheets and then review the worksheets for accuracy and clarity
• Develop a mechanism for subject recruitment and ongoing communications with primary care physicians and nursing staff, as appropriate.
• Screens and enrolls study subjects
• Manage study-related activities, subject compliance, and documentation
• Record data and study documentation
• Maintain copies of any documentation for dispensing of investigational products and/or study-related supplies
• Oversee specimen collection, storage, and shipment
• Attend study-related meetings as appropriate
• Communicate regularly with the principal investigator, monitor (and others responsible for conduct of the research) about study-related issues.
• Monitor and report adverse events
• Prepare for quality assurance audits and regulatory inspections, as needed
• Train and supervise support staff (e.g., research assistants, clerical staff and volunteers).

Requirements

• MUST HAVE relevant work experience in a clinical environment
• Must be able to work overnight, weekend, and some holidays
• Knowledge of clinical trials and medical terminology
• Knowledge of basic Computer Skills: Microsoft Office Suite, including Word PowerPoint, Excel
• Excellent time management and social skills
• Highly motivated with a phenomenal eye for detail
• Ability to maintain a professional attitude through our online workspace (proper email etiquette, willingness to show up to remote meetings, etc.)
• Preferred- BLS
• Other certification as applicable to clinical degree or program (i.e. medical assistant, medical technician, phlebotomy)
• Specialized knowledge of the unique needs of patients in the assigned therapeutic areas undergoing treatment
• Specialized knowledge of assigned therapeutic areas as it relates to research and clinical trials.
• One to two years skill in human life sciences/biomedical research; physiological, cellular, biochemical, or molecular biology
• Preferred AA/AS or BA/BS in life sciences or educational equivalent

Qualifications

• Knowledge of clinical trials and medical terminology
• Knowledge of basic Computer Skills: Microsoft Office Suite, including Word PowerPoint, Excel
• Excellent time management and social skills
• Highly motivated with a phenomenal eye for detail
• Ability to maintain a professional attitude through our online workspace (proper email etiquette, willingness to show up to remote meetings, etc.)
• BLS
• Other certification as applicable to clinical degree or program (i.e. medical assistant, medical technician, phlebotomy)
• Specialized knowledge of the unique needs of patients in the assigned therapeutic areas undergoing treatment
• Specialized knowledge of assigned therapeutic areas as it relates to research and clinical trials.
• One to two years skill in human life sciences/biomedical research; physiological, cellular, biochemical, or molecular biology
• AA/AS or BA/BS in life sciences or educational equivalent