Sub-Investigator, PA

Key Responsibilities

• Interpret clinical protocols
• Create telephone screening tools for the call center’s use in pre-screening patients
• Create study summaries, providing a basic overview of the research study as a reference for staff
• Advise on Inclusion/Exclusion set up
• Draft correspondence to subjects and follow up letters to primary care physicians
• Be familiar with all assigned studies
• Be a resource for all staff clinical questions
• Review marketing materials and give clinical input
• Additional duties and projects as assigned
• Conduct study visits with subjects
• Adhere to good clinical practices and FDA human subject protection guidelines
• Administer Informed Consent
• Review and record medical histories
• Review and record physical assessments
• Review inclusion/exclusion criteria to determine patient eligibility
• Review and record medications, indications for use, dates of use
• Assess patient compliance with study drug and follow-up visits
• Assess patient’s response to therapy
• Review and sign off on lab results and tests in consultation with Principal Investigator if needed
• Review ECG’s and provide a provisional interpretation
• Assess and document adverse events per company SOPs with final sign off by the Principal Investigators
• Conduct other visit procedures as assigned by supervisor and delegated by Principal Investigator
• May share on-call responsibilities as needed to support subjects in trials

Educational Responsibilities

• Train applicable staff on informed consent
• Train recruitment/marketing team on telephone screen tools/protocols
• Absist in recruitment team training
• Absist staff in understanding clinical requirements of the protocol
• Attend Investigator’s Meetings for new studies, as needed
• Perform “Free Screen” assessments, provide interpretation and education regarding results
• Provide in-services on scientific rationales of studies for clinical staff, as needed
• Develop, attain, and provide patient education regarding the clinical trial process as well as diseases and treatments
• Absist with writing for RCR website and newsletter as needed
• Absist with workplace wellness initiatives