Clinical Trials Research Assistant or Associate - Pediatrics Endocrine & Diabetes

University of Iowa•Iowa City, IA

About The Position

Within the Stead Family Department of Pediatrics, Division of Endocrinology, we seek to hire a full time Clinical Trials Research Assistant (PRV1) or Clinical Trials Research Associate (PRV2). This position 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 Endocrinology intends to hire either a Clinical Trials Research Assistant (PRV1) or a Clinical Trials Research Associate (PRV2), based on the qualifications of the successful candidate. Please 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 [email protected].

Requirements

Bachelor’s Degree in related field or an equivalency of education and/or related experience.
Excellent written, verbal and interpersonal communication skills.
Demonstrated proficiency with Microsoft Office and software applications, and ability to learn new applications or systems.
Experience working independently and in a group setting.
Experience managing information requiring attention to detail and high level of organization.
Experience with data entry and management.
Minimum 6 months of research experience
A Bachelor’s Degree in a related field or an equivalency of education and/or related experience.
Minimum of 1 year of research experience.

Nice To Haves

Experience in medical or clinical research directly related to endocrinology and diabetes.
Demonstrated ability to multi-task and excellent time management skills.
Knowledge of medical terminology related to pediatric endocrinology and diabetes.

Responsibilities

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 procedures. Design 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 documentation. Document 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 required. Present 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 procedures. Provide directions, assignments, feedback, coaching and counseling to ensure outcomes are achieved. Provide training and oversight on basic lab requirements and protocols.
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.
Oversee the recruitment of subjects and scheduling of trial-related procedures. Responsible for subject recruitment, subject management, scheduling, phone calls, etc. to aid in coordination of study visits.
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.
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 protocols. Meet with study monitors as requested.
Participate in managing the research staff to assure task completion and compliance with UI policies and procedures. Provide direction, assignments, feedback, coaching and counseling to ensure outcomes are achieved. Provide 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.