Senior Clinical Research Monitor - Remote -Cancer Center
Holden Comprehensive Cancer Center is seeking a Senior Clinical Research Monitor who will manage protocol development and monitoring for all new and active investigator-initiated clinical trials as well as perform auditing functions within the Clinical Research Services office the Holden Comprehensive Cancer Center (HCCC).
This position is eligible for a combination of on-campus and remote work. Work arrangement options will be discussed during the hiring process.
Other Duties and Responsibilities:
- Perform clinical study monitoring and auditing activities of the Clinical Research Services
- Provide oversight in the design and evaluation of the execution and control of clinical research trial protocols
- Serves as a senior monitor for interventional investigator-initiated trials (IITs). Participates in site initiation visits for newly opening IITs.
- Perform monitoring/auditing visits based upon a complaint or by request
- Reviews and ensures eligibility for each patient to be entered on an IIT, ensuring all prerequisites have been completed and are within the required parameters.
- Reviews new investigator-initiated protocols to assure accuracy and thoroughness of documentation as reflected in data collection forms, both paper and electronic
- Consult with investigators regarding the adequacy of eligibility checklists, protocol documents, and supplemental materials
- Monitors and documents the progress of active clinical trials, reporting study progress, toxicity summaries and compliance issues to the HCCC Data and Safety Monitoring Committee (DSMC) and/or external Data and Safety Monitoring Boards
- Performs quality audits for cooperative group, industry sponsored, grant funded, and consortium sponsored trials as requested
- Identify risks and recommend strategies, including best practices in oversight of clinical research via monitoring/auditing
- Monitor compliance with regulatory guidelines and ensure proper maintenance of documents
- Assure staff compliance with policies and procedures as they relate to clinical research and regulatory activities
- Interpret clinical research practices and human subject regulations, provide guidance to investigators and research team members
- Assist in policy development as needed based upon regulatory changes and/or internal needs
- Develop educational materials for Clinical Research Services
- Serve as an expert 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, industrial sponsors and national agencies.
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.
Percent of Time: 100%
Pay Grade: 5B 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
- A Master's degree or an equivalent combination of education and experience is required
- 3 years of clinical research or clinical trials monitoring experience
- Excellent written, verbal and interpersonal communication skills
- Excellent organizational skills
- Proficient in computer software applications including spreadsheet and database experience
- Experience in coordinating multiple projects and diverse functions independently
- Knowledge of regulations that apply to human research
- Proven ability to utilize medical terminology
Highly Desirable Qualifications
- A Master's Degree in Nursing
- Current valid Iowa Registered Nurse license
- Experience working in a research facility with clinical oncology protocols or management of clinical data, i.e., laboratory values, toxicity levels.
- Prior experience with Institutional Review Board application materials and processing
Desirable 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 subject to a criminal background check. This position is not eligible for University sponsorship for employment authorization.
With additional questions, please reach out to Hannah Smith at hannah-smith-3@uiowa.edu
Equal Opportunity/Affirmative Action employer
The University of Iowa is an equal opportunity/affirmative action employer. All qualified applicants are encouraged to apply and will receive consideration for employment free from discrimination on the basis of race, creed, color, national origin, age, sex, pregnancy, sexual orientation, gender identity, genetic information, religion, associational preference, status as a qualified individual with a disability, or status as a protected veteran. The University also affirms its commitment to providing equal opportunities and equal access to University facilities. Women and Minorities are encouraged to apply for all employment vacancies. For additional information on nondiscrimination policies, contact the Coordinator of Title IX and Section 504, and the ADA in The Office of Equal Opportunity and Diversity, 319/335-0705 (voice) or 319/335-0697 (text), The University of Iowa, 202 Jessup Hall, Iowa City, Iowa, 52242-1316.
Persons with disabilities may contact University Human Resources/Faculty and Staff Disability Services, (319) 335-2660 or fsds@uiowa.edu, to inquire or discuss accommodation needs
