Entry/Intermediate/Senior Clinical Science Professional

Job Summary

Entry/Intermediate/Senior Clinical Science Professionals perform clinical research related functions which may include patient-oriented research or research conducted with human subjects. Patient-oriented research includes mechanisms of human disease, therapeutic interventions, clinical trials, or development of new technologies. This is a part-time position, 0.75 FTE.

Examples of Duties Performed

• Assist with and oversee the day-to-day operations of clinical trials and studies
• Obtain study subject's medical history and current medication information, reviews research protocol inclusion/exclusion criteria, and confirms eligibility of subject to participate in clinical trial
• Perform informed consent process or ensures that the informed consent process has occurred, is properly documented, and that informed consent form documents are filed as required
• Interview prospective subjects for a variety of research clinical trials. Educate potential subjects on the details of the studies through phone contacts and personal interviews
• Schedule subject participation in research clinical trial, coordinating availability of necessary space, and clinical research support
• Collect, code, and analyze data obtained from research in an accurate and timely manner
• Adhere to research regulatory standards
• Maintain detailed records of studies to ensure compliance with requirements of the study protocols, department, hospital/clinical standard operating procedures and other regulatory guidelines
• Participate in subject recruitment efforts, including communicating with patients expressing an interest and all pre-screening/screening activities
• Ensure that the necessary supplies and equipment for studies are in stock and in working order
• Independently master study materials, including but not limited to protocols, informed consent forms, and all other essential study documents for assigned studies
• Independently perform study related processes, procedures, and assessments as defined in study protocol and in compliance with regulating bodies
• Assist Team Leads, Supervisors and/or management with creation and implementation of processes and procedures and quality improvement initiatives
• Act as a Primary Coordinator on multiple trials/studies
• Assist and train junior team members
• Assist with developing or develops protocol-specific systems and documents including process flows, training manuals, Standard Operating Procedures (SOPs) and Case Report Forms (CRFs)
• Assist with identifying issues related to operational efficiency and shares results with leadership
• Collect information to determine feasibility, recruitment and retention strategies
• Serve as a resource and participate in study initiation and close out duties

Additional examples of work performed

• Recruits and pre-screens potential study participants and coordinates advertisements via social media, flyers, etc.
• Manages study record in OnCore.
• Conducts the informed consent process and ensures proper documentation.
• Reviews protocol inclusion/exclusion criteria and confirms study eligibility.
• Assures protocol compliance and completes necessary records; maintains Standard Operating Procedures (SOPs).
• Accurately enters source data into the study database in a timely manner; reviews records after each visit for completeness and accuracy.
• Manages scheduling of participants, tracks subject participation, and runs study visits.
• Recognizes and tracks adverse events and serious events and promptly notifies appropriate parties.
• Attends lab and study team meetings.
• Collects and processes biological samples.
• Data entry and quality assurance reviews in REDCap and Excel.