Support, conduct and manage clinical trials to deliver and evaluate research protocols and clinical trials in the Gastroenterology and Hepatology Division of Internal Medicine. Key areas of responsibility include protocol development/management and study responsibilities; research/clinical activities, subject recruitment and enrollment, data collection and monitoring; and regulatory guidelines and documents.
KEY AREAS OF RESPONSIBILITY
Responsible for opening, maintaining, and closing clinical trials: provide leadership, oversight and management of multiple complex clinical studies.
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) as well as external IRBs such as WCG IRB and Advarra CIRB; prepare consent forms for research protocols.
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 when necessary. Perform preliminary investigation and analysis, including basic comparison of practice to regulations across teams.
Responsible for the preparation and submission of documents related to research protocol annual reviews, modifications, Adverse Events, Safety Reports and other reportable events to IRB as needed; manage all regulatory requests to sponsors and detailed letters of correspondence to the IRB.
Responsible for regulatory process and document preparation used in the implementation and maintenance of clinical trials sponsored by industry, national agencies, consortia, and cooperative.
Analyze and prepare data/reports as needed, and serve as liaison to clinicians, research investigators, data managers, nursing services staff, pharmacists and medical personnel to ensure sufficient cooperation among participating investigators for each clinical research study; maintain liaison with participating University departments, industry sponsors and national agencies. Assist in the execution, administration and maintenance of protocols and clinical studies. Provide input into descriptions of research procedures. Develop study materials.
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 perform on-site audits of research data.
Monitor compliance with regulatory guidelines and ensure proper maintenance of documents. Maintain regulatory files and binders.
Resolve monitoring and auditing issues that relate to regulatory activities.
Coordinate and prepare for monitor visits and audits.
Enter data for the evaluation of clinical research metrics through our OnCore database as it relates to the initial regulatory review and submission process.
Assure staff compliance with 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.
REQUIRED QUALIFICATIONS
A Bachelor's degree or an equivalent combination of education and experience.
6 months - 1 year of administrative and/or program experience.
Excellent written, verbal and interpersonal communication skills
Excellent organizational skills.
Proficient in computer software applications including spreadsheet and database experience.
DESIRABLE QUALIFICATIONS
Experience in coordinating multiple projects and diverse 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.
Application Process:
In order to be considered for an interview, applicants must upload the following documents and mark them as a "Relevant File" to the submission: • Resume • Cover Letter Job openings are posted for a minimum of 14 calendar days and may be removed from posting and filled any time after the original posting period has ended.
Successful candidates will be required to self-disclose any conviction history and will be subject to a criminal background check and credential/education verification.. Up to 5 professional references will be requested at a later step in the recruitment process.
For additional questions, please contact michaela-davis-1@uiowa.edu
