Prms Coordinator - Cancer Center

Duties To Include

The Holden Comprehensive Cancer Center is seeking a PRMS Coordinator to assist in the administration of activities related to the review, management, and monitoring of new and ongoing research protocols submitted through the Holden Comprehensive Cancer Center’s (HCCC) Protocol Review and Monitoring System (PRMS). Additionally, this position assists in the coordination of data management and reporting activities for the HCCC Clinical Trials Management System (OnCore), related systems, and databases to support HCCC clinical trial operations.

• Assists in the ongoing maintenance and testing of new and existing software integrations with OnCore including HawkIRB, Epic, Advarra Insights, eReg, EDC, and other products.
• Participates in the development of general goals for HCCC protocol management.
• Assists in maintaining documentation of protocols and relevant data, follow-up correspondence, and summaries.
• Enter, maintain, and update protocol data in the HCCC Clinical Trials Management System, OnCore. Assist with data queries, analyzing results, and developing reports as requested by administrative staff. Identify issues and problems and provide feedback to appropriate administrative staff.
• Assist in the processing of new protocols, prepare forms and reports, communicate with investigators, reviewers, committees, and staff. Audit information for accuracy and completeness; identify issues, compose queries, and facilitate solutions.
• Assists with other projects and support as needed.
• Assist in the ongoing management of HCCC’s Protocol Review and Monitoring Committee (PRMC) including the scheduling of committee meetings, preparing agendas, and meeting minutes.
• Assists in initial registration and ongoing updates including results reporting of clinical trials to the National Institutes of Health (NIH) clinicaltrials.gov in accordance with FDAAA and ICMJE reporting requirements.
• Manage the processing protocol modifications and continuing reviews in OnCore via the system’s integration with HawkIRB and Epic, ensuring all impacted fields and documentation are updated and accurate.
• Assists in the initial registration and ongoing updates of clinical trials and subject enrollment data to the National Cancer Institute’s (NCI) Clinical Trials Reporting Program (CTRP).
• Assists in monitoring Quality Assurance (QA) of data within OnCore and performing routine QA checks via various OnCore reporting tools. This position will also help with other mandatory reporting requirements and SOP development. Assists in judging validity of data; makes recommendations for change as opportunities for improvement are identified in close collaboration with protocol management staff.

Universal Competencies

• Ability to meet or exceed customer service needs and expectations and provide excellent service in a direct or indirect manner. Ability to effectively transmit and interpret information through appropriate communication with internal and external customers.
• Ability to utilize existing resources and learning to achieve or exceed desired outcomes of current and future organizational goals/needs. Able to demonstrate ethical behavior in diverse situations while producing results.
• Ability to work with a variety of individuals and groups in a constructive and civil manner while appreciating the unique contribution of individuals from varied cultures, race, creed, color, national origin, age, sex, disability, sexual orientation, and gender identity.

Technical Competencies

• Knowledge of and ability to utilize tools, techniques and processes for gathering and reporting data in a particular department or division of a company.
• Knowledge of tools, techniques and resources for obtaining or validating information to be published, exhibited or presented in a variety of methods.
• Knowledge of practices, behaviors, applicable laws, rules, and regulations governing proper research conduct; ability to demonstrate ethical and compliant behavior in diverse situations.
• Knowledge of theories and methodologies of medical science research.

Supervision Received

Administrative supervision is provided by the PRMS Supervisor.

Supervision Exercised

N/A

University of Iowa Hospitals & Clinics—recognized as one of the best hospitals in the United States—is Iowa's only comprehensive academic medical center and a regional referral center. Each day more than 12,000 employees, students, and volunteers work together to provide safe, quality health care and excellent service for our patients. Simply stated, our mission is: Changing Medicine. Changing Lives.®

Holden Comprehensive Cancer Center is Iowa’s only NCI-designated comprehensive cancer center. The NCI designation recognized our cancer center, and its research scientist, physicians, and other health care professionals, for their roles in advancing cancer research that impacts on our ability to prevent, detect and treat our patients with cancer. Not just a floor, or a building, or even confined to a single college. Holden Comprehensive Cancer Center coordinates all cancer-related research, education, and patient care by faculty from 41 departments and six colleges, as well as UI Hospitals and Clinics and UI Children’s Hospital.

UI Health Care Core Values (WECARE)

Welcoming

We strive for an environment where everyone has a voice that is heard, that promotes the dignity of our patients, trainees, and employees, and allows all to thrive in their health, work, research, and education.

Excellence

We aim to achieve and deliver our personal and collective best in the pursuit of quality and accessible healthcare, education, and research.

Collaboration

We encourage collaboration with healthcare systems, providers, and communities across Iowa and the region, as well as within our UI community. We believe teamwork – guided by compassion – is the best way to work.

Accountability

We behave ethically, act with fairness and integrity, take responsibility for our own actions, and respond when errors in behavior or judgement occur.

Respect

We are committed to ensuring the UI Health Care is an inclusive environment where individuals from the full spectrum of diversity – which includes identity, backgrounds, cultures, ability, and perspective – feel safe, seen and valued.

Equity

We dedicate ourselves to equity and fairness in research, health care, education, and health.

Percent of Time: 100%

Pay Grade: 3B

https://hr.uiowa.edu/pay/guide-pay-plans

Benefits Highlights

• Regular salaried position located in Iowa City, Iowa
• Fringe benefit package including paid vacation; sick leave; health, dental, life and disability insurance options; and generous employer contributions into retirement plans
• For more information about Why Iowa?, click here

Required Qualifications

• Experience with medical terminology.
• 6 months to 1 year experience in a health care setting.
• Proficient in computer software applications.
• Bachelor’s degree or an equivalent combination of education and experience.
• Excellent verbal, written and interpersonal communication skills.
• Ability to manage complex information with attention to detail and a high level of accuracy.

Highly Desirable Qualifications

• Knowledge of regulatory guidelines and procedures.
• Experience with OnCore.
• Knowledge of clinical oncology research protocols.
• Experience with RedCap or similar electronic data capture software.
• Relevant experience in the conduct of clinical research studies.

Desired Qualifications

• Knowledge of University of Iowa policies, procedures and regulations.

Application Process: In order to be considered, applicants must upload a resume and cover letter (under submission relevant materials) that clearly address how they meet the listed required and desired qualifications of this position.

Job openings are posted for a minimum of 14 calendar days.

Successful candidates will be required to self-disclose any conviction history and will be subject to a criminal background check and credential/education verification.

References: Five professional references will be requested and required at a later step in the recruitment process

This position is not eligible for University sponsorship for employment authorization.

With additional questions, please reach out to Sarah Waldschmidt at [email protected]

Additional Information

• Schedule: Full-time
• Classification Title: Compliance Coordinator
• Appointment Type: Professional and Scientific

Compensation

• Pay Level: 3B

Contact Information

• Organization: Healthcare
• Contact Name: Sarah Waldschmidt
• Contact Email: [email protected]