Clinical Trials Research Associate - Gastroenterology/Hepatology

The Clinical Trial & Database Management Research Associate will serve as a member of the research team at the University of Iowa, Division of Gastroenterology and Hepatology within Internal Medicine. The primary responsibility is to support, conduct and manage the regulatory aspect of 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 regulatory management; understanding and following through with regulatory guidelines; documents and submission; and CRF development and data entry.

KEY AREAS OF RESPONSIBILITY

Protocol Development/ Management and Study Responsibilities:

Assist coordinators in the development of data management plans; design complex study materials to facilitate the collection and tracking of study participant data, study drugs, biological specimens, and study procedures.

Assist with CRF development.

Prepare and submit pre site selection visit documents.

Oversee regulatory monitoring visit issues and assist with query reports; oversee close out visits.

Serve as a liaison to sponsors and CROs.

Provide training and guidance on regulatory issues.

Research/Clinical Activities; Subject Recruitment and Enrollment:

May oversee clinical, data and patient coordination for observational/non-drug research activities.
Data Collection and Monitoring:

Participate in the design, development, and testing of clinical research trials data systems

Lead the coordination of studies and data in the I-CTMS system.

Validate data, query resolution, and make recommendations for resolution.

Revise and implement change in data collection.

May assist with data processing tasks; enter data, verify data, identify problem data, generate queries, etc.

Regulatory Guidelines and Documents:

Manage and organize regulatory documentation from sites and regulatory authorities.

Manage and organize regulatory documents from sponsors and CROs.

Prepare regulatory submissions and start-up activities for new studies; submit to both local and central IRBs.

Perform on-site audits of research and clinical data.

Monitor compliance of regulatory guidelines and proper maintenance of documents; submit annual reports.

Assume responsibility for reportable events reporting, and any corrective actions taken.

Assist with obtaining signatures on regulatory documents and point of contact for monitors.

Serve as a liaison with IRB staff, regulatory authorities, and investigators and study coordinators.

Human Resources/Leadership:

May provide functional and/or administrative supervision.

Mentor new staff under direction.

Financial Responsibility:

Review budget for patient compensation information.

Assist with patient compensation reimbursement.

About Gastroenterology/Hepatology
Since its foundation nearly 40 years ago, the Division of Gastroenterology and Hepatology has continuously distinguished itself as a highly ranked specialty within the Department of Internal Medicine. As part of the James A. Clifton Digestive Health Center, it provides state of the art medical care to patients with gastrointestinal or liver diseases and nutritional problems in a multidisciplinary environment. The Center also plays an important role in the education of students, residents and fellows and offers a variety of learning opportunities for continuing medical education of physicians and other health care professionals. The nationally and internationally recognized faculty conducts many clinical and basic science research projects to further our understanding of gastrointestinal and liver diseases and help design better treatment for patients with these illnesses.