Clinical Trials Research Assistant - Pediatric Neurology

UIOWA•Iowa City, IA

About The Position

To manage and support clinical trial regulatory activities for the Pediatric Department, Clinical Research Services. Act as back-up study coordinator for studies as appropriate. This is a specified term position. Duties to include: Take primary responsibility in collaboration with study lead coordinator to complete regulatory activities to open new clinical trials. Serve as a resource and support to study coordinators for regulatory activities required to maintain and close clinical trials. Coordinate specific aspects of external review and internal processes. Specifically, oversee the preparation and submission of the appropriate Human Subjects Review forms and application materials to the Institutional Review Board (IRB-01), and central IRB entities. Collaborate with study-specific coordinator to prepare consent forms for research protocols and local and central IRB submissions. Prepare and submit application forms and serve as liaison to the Clinical Research Unit (CRU), the Pharmacy and Therapeutics Committee, the Medical Radiation Protection Committee, the Protocol Review and Monitoring Committee, Joint Office of Compliance, Nursing Research Committee, Pathology Committee, and other review committees as necessary. Support the primary study coordinator(s) as needed on additional regulatory tasks (such as annual reviews, modifications, Adverse Events, Safety Reports and other reportable events to IRB). Coordinate the regulatory process and document preparation used in the implementation of clinical trials. Serve as liaison to clinicians, research investigators, data managers, nursing services staff, pharmacists and medical personnel to ensure sufficient cooperation among participating stakeholders for each clinical research study. Assist in the execution, administration and maintenance of protocols and clinical studies. Provide input into descriptions of research procedures. Coordinate specific aspects of external review and align with internal processes. Manage and organize regulatory documentation from sites and regulatory authorities. Prepare regulatory submissions and assist with on-site audits when needed. Monitor compliance with regulatory guidelines and ensure proper maintenance of documents. Work with primary coordinator to develop regulatory files and binders, assist as requested in maintenance. Assist primary study coordinator(s) with monitoring and auditing issues that relate to regulatory activities, when needed. Enter data for the evaluation of clinical research metrics through our OnCore database as it relates to the initial regulatory review and submission process. Assist study staff with compliance of policies and procedures as they relate to regulatory activities. Prepare and deliver basic content that enhances knowledge of and compliance with internal and external standards and regulations. Attend all appropriate meetings as assigned: this will include but is not limited to with internal and external groups to provide reporting of study updates, educational and training meetings, meetings with team leads and supervisors, and meetings with sponsors or CROs. Assist in general coordinator activities as required as a back-up coordinator. These might include study-specific training, assist with preparing for and completing subject visits, data entry, and other study specific tasks as appropriate.

Requirements

A Bachelor’s Degree or an equivalent combination of education and experience
Excellent written, verbal and interpersonal communication skills
Excellent organizational and time management skills
Proficient in computer software applications including spreadsheet and database experience
Experience in coordinating multiple projects and various functions independently
Prior experience with Institutional Review Board application materials and processing
Knowledge of regulations that apply to human research
Proven ability to utilize medical terminology

Nice To Haves

Experience working in a research facility with protocols or management of clinical data, i.e., laboratory values, toxicity levels
1-3 years administrative and/or program management experience
Knowledge of University of Iowa policies, procedures and regulations

Responsibilities

Complete regulatory activities to open new clinical trials.
Serve as a resource and support to study coordinators for regulatory activities required to maintain and close clinical trials.
Oversee the preparation and submission of Human Subjects Review forms and application materials to the Institutional Review Board (IRB-01), and central IRB entities.
Collaborate with study-specific coordinator to prepare consent forms for research protocols and local and central IRB submissions.
Prepare and submit application forms and serve as liaison to various committees and review boards.
Support study coordinator(s) on additional regulatory tasks (annual reviews, modifications, Adverse Events, Safety Reports).
Coordinate the regulatory process and document preparation for clinical trials.
Serve as liaison to clinicians, research investigators, data managers, nursing services staff, pharmacists and medical personnel.
Assist in the execution, administration and maintenance of protocols and clinical studies.
Provide input into descriptions of research procedures.
Manage and organize regulatory documentation from sites and regulatory authorities.
Prepare regulatory submissions and assist with on-site audits.
Monitor compliance with regulatory guidelines and ensure proper maintenance of documents.
Develop regulatory files and binders.
Assist with monitoring and auditing issues that relate to regulatory activities.
Enter data for the evaluation of clinical research metrics through our OnCore database.
Assist study staff with compliance of policies and procedures as they relate to regulatory activities.
Prepare and deliver basic content that enhances knowledge of and compliance with internal and external standards and regulations.
Attend appropriate meetings to provide reporting of study updates, educational and training meetings, meetings with team leads and supervisors, and meetings with sponsors or CROs.
Assist in general coordinator activities as required as a back-up coordinator, including study-specific training, preparing for and completing subject visits, and data entry.