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Job Description

Help patients with diabetes in Iowa navigate the value Iowa Diabetes team can provide them through research, care, education and technology. Become a champion for the patients and help them solve their diabetes problems and have better health. Hours need to be flexible to include evenings and weekends to be able to reach our patients at the times that they are available.

Required Qualification

Minimum Knowledge, Skills and Abilities Required

• General high school diploma or equivalent
• At least 1 year of work experience
• Knowledge of business English, spelling, arithmetic, modern office practices and procedures, standard office equipment.
• Proficiency in Microsoft Office/Google Suite of products

Key Responsibilities

• 10% – Promotion/Outreach-Build and maintain relationships in the community including subsites as well as referral clinics. Conduct and coordinate community events such as local health fairs and patient support groups throughout the week (including evenings/weekends as applicable). Maintain and improve local marketing contacts and patient databases for recruitment.
• 35% – Patient Navigation and Communication-Respond to calls from interested patients for our services in a timely manner. Guide the patient to services at IDR that would meet the needs of the patient through Research, clinic, education or technology. Contact potential patients and assist with scheduling and tracking appointments and entering notes/data in appropriate systems. Educate current and prospective patients on the benefits of the IDR portal and EMR connection. Assist with sign-ups and answer questions to ensure a continual growth and usage of the services offered.
• 55% – Clinical Trial Recruitment-Actively seek patients for enrolling studies using Patient Qualifier and by screening medical records for subsites and partner clinics, identifying potential patients using inclusion/exclusion criteria. Work with the Clinical Research Team to adequately recruit patients based on the criteria provided and schedule screening visits.

Job Description

Further the development of medications and therapies for people living with diabetes & related conditions through the conducting of research study visits in adherence to FDA and sponsor guidelines.

Required Qualification

• CMA, LPN or RN
• 1 to 3 years in patient care or research
• Knowledge of business English, spelling, arithmetic, modern office practices and procedures, standard office equipment.
• Proficiency in Microsoft Office/Google Suite of products
• CPR Certification (obtained within 6 months of start date)

Key Responsibilities

• 45% – Conduct clinical studies according to GCP & FDA regulations and guidelines to ensure the safety and welfare of the study participants. Assist medical investigators in understanding and implementing the protocol. Screen potential study participants according to the protocol’s inclusion/exclusion criteria. Obtain proper written informed consent from each study participant prior to participation in the study. Plan & schedule clinical research activities. Communicate with the sponsors regarding study activities as necessary. Collect blood (phlebotomy), urine, and other human specimens as required by clinical studies. Obtain patient vitals and electrocardiograms ( ECG’s). Maintain patient confidentiality and follow HIPAA guidelines and regulations. Collaborate with subsites and perform research activities at the sub-site locations according to protocol.
• 30% – Understand the study protocol so all study activities are completed correctly and concurrently. Document the study activities with accurate and complete data. Maintain adequate and accurate case histories for each study participant. Perform internal audits of studies. Review the study protocols to capture all the supporting data to the study. Report all adverse experiences to the Investigator and sponsor. Enter the study data into the electronic case report forms in the required timelines and follow up on the queries in a timely manner. Create the source documents to ensure all data points are recorded. Complete study related training in a timely manner. Ensure protocol amendments, notices, suspensions & terminations are implemented. Maintain awareness of all regulatory documents and ensure all required documents are completed real-time to ensure we are audit ready at all time. Maintain all required documentation in the study file. Use computer applications to enhance the efficiency of the workflow and study activities. Assist with performing quality assurance measures and other quality improvement opportunities as directed by the Leadership team.
• 15% – Maintain professional mannerisms in communication with the Sponsors and study personnel. Meet with sponsor representatives to discuss the conduct of the study and review study data. Inform the Sponsor of any study protocol deviations, issues with study participants, etc and proper documentation is retained. Communicate with the IRB. Maintain and enhance rapport with research partners. Communicate with sub-sites to ensure all study specific activities are covered including scheduling physicals, reviewing study procedures, etc. Help improve the sub-site collaboration to increase the patient visits to maintain the established relationship
• 10% – Strategize with recruitment coordinators to meet the targets for each study. Actively support and contribute to patient recruitment activities including but not limited to outreach, marketing and telephone screening. Educate patients on the value of the Iowa Diabetes Portal and EMR connect. Assist with registration as needed. Collaborate with finance to ensure visits are appropriately entered and invoiced. Respond to all study or visit related requests in a timely manner. Submit written documentation for items that must be manually billed on an agreed upon basis. Notify finance of expected last patient visit date.

Job Description

This position is responsible for managing and conducting all regulatory activities that are related to conducting clinical research trials.

Required Qualification

Minimum Knowledge, Skills, and Abilities Required

• Associate’s or Bachelor’s Degree (may be substituted with relevant experience)
• 1 to 3 years working with complex documents
• Detail-oriented with a high level of organization
• Knowledge of business English, spelling, arithmetic, modern office practices and procedures, standard office equipment
• Proficiency in Microsoft Office/Google Suite of products

Key Responsibilities

• 30% – Internal Activities-Lead regulatory maintenance of ongoing studies by processing protocol amendments, med-watches and other regulatory documentation and communication of protocol updates in a timely manner. Collaborate with PI to coordinate and maintain sponsor requested documentation as directed. Collaborate with Clinical Research Coordinators to close completed studies.
• 30% – External Activities-Communicate with the clinical team to be prepared for Monitor Visits by ensuring all regulatory documents are complete and filed appropriately. Respond to monitor issues, create documents, get signatures and lead necessary follow ups. Assist in the preparation of regulatory binders for audits. Complete annual regulatory updates for all clinical trials. Maintain informational binders for Institutional Review Boards used by IDR. Communicate with IRB and sponsor and ensure all documentation is complete for study closure.
• 20% – New Study Start Up-Prepare regulatory documents for the implementation of new clinical research trials. Collaborate with PI, Sub I’s, Recruiting and Screening Coordinators and Clinical Research Coordinators to complete and submit all forms in a timely manner. Prepare submission packet for Institutional Review Board. Keep stakeholders up to date on progress and maintain easily accessible files of all submissions. Work with the leadership team to ensure clinical trial start-up activities and advertisement submissions are completed in a timely manner.
• 20% – Training Coordination-Prep materials for the Investigator meetings with the proper training materials for New studies and protocol amendments or notifications on important communication. Complete the presentation and allow for PI to approve materials for the Investigator Meeting and make sure all appropriate personnel are invited to the meeting. Ensure all study specific personnel are alerted and trained on updated information when available and keep all training documented and filed. Track all employee training for GCP, NIH, IATA, CVS, Medical Licenses, etc as applicable. Communicate with the team when due for specified training and follow up to ensure they are filed appropriately. Participate in special projects and sub committees as assigned by the Leadership Team.