Interested in Applying?
With our core team values of being focused and fun, providing an exceptional experience to those we serve, a quality-driven team that pursues excellence every day, and being passionate and enthusiastic about helping people affected by diabetes, our employees accomplish many challenging yet rewarding experiences here at Iowa Diabetes. Along with career-growth opportunities and amazing benefits, our employees are involved in rewarding work that is impacting people’s lives, supported by a family-like team culture. Joining our team is a great way to achieve your goals or enhance your career skills!
Apply if You…
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Want to Grow Professionally
We are a fast-paced organization with multiple ongoing projects at any given time. We value employees with a high degree of autonomy who like to take initiative with their work and are flexible to take on new tasks and projects frequently. Your work here will help you gain valuable long-term skills such as multi-tasking and prioritization to ensure success in future positions too.
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Want to Serve Patients in Unique Ways
At Iowa Diabetes, we are focused on delivering exceptional care to our patients at our research center, clinic, and through our education programs. If you are patient-centered in your work approach and want to be a part of a passionate team, this could be the place for you.
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Have Great Communication Skills
We are looking for employees who are skilled at communicating with other members of our team as well as patients. Whether it be writing proposals for collaborating with other organizations or presenting projects to other team members, great communication is a key factor in enabling us to operate at full steam.
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Want Comprehensive Benefits
At Iowa Diabetes we offer our employees value-adding benefits such as: 1) 401(k) 2) 401(k) matching 3) Dental Insurance 4) Employee assistance program 5) Flexible schedule 6) Flexible spending account 7) Health insurance 8) Life insurance 9) Paid time off 10) Vision insurance
Position Summary
Lead a team charged with furthering 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.
Core Job Responsibilities
This is the expected job description but the employee may be asked to perform other duties assigned by the supervisor or company leadership. This position would require onsite working hours with flexibility in the evenings/weekends in order to support visits and/or attend outreach events, etc.
| Responsibility | % | Description |
|---|---|---|
| Leadership | 50% |
Promote a positive and nurturing environment that fosters employee retention, growth and continual improvement and helps them achieve company goals effectively and efficiently. Facilitate hiring, on-boarding, performance evaluations, disciplinary action, counseling and termination. Maintain a dynamic growth and development plan (GDP) for each employee. Proactively invest in plans to increase team members’ knowledge and education and resolve issues related to job knowledge and performance. Ensure the department is adequately staffed and minimize overtime. Maintain primary loyalty to the leadership team (The First Team). Engage in strategic planning and implementation, putting the company’s needs before that of self or one’s own department. Speak in a unified voice with staff outside the leadership team; always in support of company initiatives and other leaders. Escalate team members’ concerns/issues to the leadership team and CEO as necessary. Continually seek opportunities to improve processes, while maintaining a focus on quality. Ensure the team’s responsibilities and key processes (SOPs or PWIs) are well documented and employees are being held accountable for their adherence and performance. Cross train employees to ensure backups for all key processes. Manage team to success through effective delegation and completion of all shared responsibilities. Assign the new Research studies to the CRCs for primary and back up responsibilities based on the workload and current status. Participate in and maintain an on-call schedule for the Clinical Team. |
| Quality | 20% | Lead the quality Initiatives within the CRC Team. Work with the Quality department to implement spot checks on the highest risk areas in Clinical Research (IP logs, source completion, filing, etc.) to ensure an audit ready all the time environment. Ensure that the core quality processes are documented and all company personnel are trained based on the roles. Ensure source readiness and review for the Research studies to ensure all documentation is captured per protocol. |
| Patient Care | 20% | 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. 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. 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. |
| Quantity | 10% | Collaborate with the Navigator Team 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. Meet with the Navigator Manager at the study start to ensure recruitment readiness to get ready for the first patient visit at site. |
Minimum Knowledge, Skills and Abilities Required
- 1 to 3 years in Healthcare management preferred
- Bachelor’s Degree preferred
- Background in Clinical Research preferred
- 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)
Physical, visual, intellectual requirements and workplace conditions can be found in the job appendix.
