Clinical Trials Research Associate - Gastroenterology/Hepatology

BASIC FUNCTION

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

Management of Regulatory Guidelines and Documents:

• Responsible for opening, maintaining, and closing clinical trials: provide leadership, oversight and management of multiple complex clinical studies. Serve as a liaison with IRB staff, regulatory authorities, and investigators and study coordinators.
• Coordinate external and internal review processes. Prepare and submit pre site selection visit documents. 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 and any corrective actions taken; manage all regulatory requests to sponsors and detailed letters of correspondence to the IRB. Perform on-site audits of regulatory documents. Monitor compliance with regulatory guidelines and ensure proper maintenance of documents. Maintain regulatory files and binders.
• Responsible for regulatory process and document preparation used in the implementation and maintenance of clinical trials sponsored by industry, national agencies, consortia, and cooperative. 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.
• 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.
• Coordinate and prepare for monitor visits and audits. Resolve monitoring and auditing issues that relate to regulatory activities. Manage and organize regulatory documents from sites, regulatory authorities, sponsors and CROs. Serve as a liaison to sponsors and CROs. Oversee regulatory monitoring visit issues and assist with query reports; oversee close out visits. Obtain signatures on regulatory documents and point of contact for onsite and remote monitors.
• Lead the coordination of studies and data in the Advarra eReg system and enter data for the evaluation of clinical research metrics through our Advarra eReg database as it relates to the regulatory review and submission process.
• Assure staff compliance with policies and procedures as they relate to regulatory activities. Provide training and guidance on regulatory issues. 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.

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.

The department intends to hire for one position as either a Clinical Trials Research Assistant, requisition 25004144 or Clinical Trials Research Associate, requisition 25004146, based on the qualifications of the successful candidate. Please apply to the specific position for which you which to be considered or both.

REQUIRED QUALIFICATIONS

• A Bachelor's degree or an equivalent combination of education and experience is required.
• 6 months - 1 year of related experience with preparation of IRB submissions or regulatory submissions with clinical trials is required.
• Excellent written and verbal communication skills are required.
• Excellent time management skills and the ability to perform detail-oriented work independently is required.
• Proficiency in computer software applications (MS Word, Excel, Outlook, and PowerPoint) is required.

DESIRED QUALIFICATIONS

• Experience with EPIC is desirable.
• Experience with OnCore or Advarra eReg is desirable.
• Experience with following specific protocol techniques and management is desirable.
• Knowledge of University of Iowa policies, procedures and regulations is desirable.

Position and Application Details

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 ....

• Classification Title: Clin Trials Rsrch Associate
• Appointment Type: Professional and Scientific
• Schedule: Full-time

• Pay Level: 4A

• Organization: Healthcare
• Contact Name: Ashley Nelson
• Contact Email: ...