Sub-Investigator

Job Description

Job Summary

The Sub-Investigator, under the supervision of the Principal Investigator, is responsible for both clinical and educational aspects of clinical trial studies while focused on interpreting clinical protocols and conducting study visits with subjects.

Key Responsibilities

Clinical 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
• Assist in recruitment team training
• Assist 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
• Assist in writing for RCR website and newsletter as needed
• Assist with workplace wellness initiatives

Qualifications

• Excellent verbal and written communication skills.
• Excellent interpersonal and customer service skills.

Education and Experience

• NP with NYS certification as Family or Adult NP or PA
• At least two years’ clinical experience preferred