Clinical Trials Research Assistant or Associate Pediatrics Endocrine & Diabetes

Within the Stead Family Department of Pediatrics Division of Endocrinology we seek to hirea full time Clinical Trials Research Assistant (PRV1) or Clinical Trials Research Associate (PRV2). Thisposition will provide support for Pediatric Endocrinology and Diabetes Clinical Research by conducting study visits collecting and analyzing results and performing operational duties associated with human research. This is a specified term position.

The Division of Endocrinologyintends to hire either a Clinical Trials Research Assistant (PRV1) or a Clinical Trials Research Associate (PRV2) based on the qualifications of the successful indicate in your application materials the position you wish to be considered for or indicate both.

Pay Level:3A (PRV1) or 4A (PRV2)

Full job descriptions for both positions can be obtained by emailing

Primary responsibilities of the Clinical Trials Research Assistant (PRV1; 3A) include:

• Perform research activities in a specialized area.
• Consult with principal investigator to design forms to facilitate the collection and tracking of participant data study drugs and study study source documents assessment tools and participant questionnaires.
• Meet with families to introduce them to research opportunities currently available.
• Perform procedures and techniques as outlined in clinical research protocols assure fidelity to protocols.
• Complete basic lab processing sample storage and lab shipments per protocol.
• Use statistical analysis software (REDCap) to analyze and summarize study data.
• Submit protocols to the IRB and other review committees for approval prior to implementing research as necessary for modifications and then annually for continuing review approvals.
• Responsible for safety programs by following guidelines and maintaining required all participant Serious Adverse Events and Adverse Events and report these to the primary investigator study sponsor and IRB.
• Attend local and national research meetings as results findings or updates.
• Attend local fundraising events and activities to market and recruit participants for research studies.
• Conduct routine maintenance and controls on continuous glucose monitoring devices glucose meters YSI analyzer and centrifuge.
• Participate in managing the student research staff to ensure task completion and compliance with UI policies and directions assignments feedback coaching and counseling to ensure outcomes are training and oversight on basic lab requirements and protocols.

Primary responsibilities of the Clinical Trials Research Assistant (PRV2; 4A) include:

• Perform research activities in a specialized area.
• Assist in the design development execution administration and maintenance of protocols and clinical studies. Assist in study design and protocol development and provide input into descriptions of complex research procedures.
• Consult with principal investigator to design forms to facilitate the collection and tracking of participant data study drugs and study procedures.
• Oversee the recruitment of subjects and scheduling of trial-related procedures.
• Meet with families to introduce them to research opportunities currently available. Responsible for subject recruitment subject management scheduling phone calls etc. to aid in coordination of study visits.
• Perform procedures and techniques as outlined in clinical research protocols assure fidelity to insulin pumps and glucose meters; assist with tolerance tests clamp studies and other procedures.
• Participate in the design development and testing of clinical research trials data systems. Validate data query resolution and make recommendations for resolution. Revise and implement change in data collection.
• Use statistical analysis software (REDCap) to analyze and summarize study data.
• Submit protocols to the IRB and other review committees for approval prior to implementing research.
• Responsible for safety programs by following guidelines and maintaining required all participant Serious Adverse Events and Adverse Events and report these to the primary investigator study sponsor and IRB.
• Monitor implementation of study per protocol and ensure procedures are conducted using good clinical practice standards and meeting IRB guidelines.
• Manage and organize regulatory documentation from sites and regulatory authorities. Prepare regulatory submissions. Perform on-site audits of research and clinical data.
• Collaborate with Study Sponsors and Coordinating Centers to manage with study monitors as requested.
• Attend local and national research meetings as results findings or updates.
• Attend local fundraising events and activities to market and recruit participants for research studies.
• Conduct routine maintenance and controls on continuous glucose monitoring devices glucose meters YSI analyzer and study equipment to ensure safety of study participants and monitor environmental risks.
• Coordinate manage and test and resolve equipment failures error codes and repairs.
• Participate in managing the research staff to assure task completion and compliance with UI policies and direction assignments feedback coaching and counseling to ensure outcomes are training and oversight into basic lab requirements and protocols.
• May provide functional and/or administrative supervision. Mentor new staff under direction.
• Assist in preparing budgets for studies and timely billing compliance for studies.