PS Clinical Research Coord Sr. at University of Utah
Salt Lake City, UT 84112
About the Job
PS Clinical Research Coord Sr.
Job Summary
The Division of Pediatric Hematology/Oncology at the University of Utah School of Medicine has an immediate opening for a Sr. Clinical Research Coordinator (Sr. CRC). The incumbent coordinates complex clinical trial activities and plays a critical role in the conduct of multiple research studies for the treatment of pediatric cancers. The Sr. CRC assists the clinical trials process by registering patients for clinical studies, assessing eligibility criteria, maintaining current study documents, and assuring that all quality assurance measures are maintained within the protocol/study. The Sr. CRC. assists the Principal Investigator in all IRB and regulatory submissions and clinical coordination specific to protocol. They coordinate the implementation, quality control and completion of research studies while assisting the Principal Investigator in determining and accomplishing study objectives. The Sr. CRC oversees research studies in an administrative and operational capacity while maintaining compliance with guidelines set by governing agencies.
The University of Utah offers a comprehensive benefits package including:
- Excellent health care coverage at affordable rates
- 14.2% retirement contributions that vest immediately
- Generous paid leave time
- 11 paid Holidays per year
- 50% tuition reduction for employee, spouse, and dependent children
- Flex spending accounts
- Free transit on most UTA services
- Employee discounts on a variety of products and services including cell phones & plans, entertainment, health and fitness, restaurants, retail, and travel
- Professional development opportunities
Additional benefits information is available at www.hr.utah.edu/benefits
Responsibilities
- Oversees, assesses, and ensures participant safety and strict protocol implementation/adherence; oversees compliance with GCP guidelines, federal regulations, institutional policies and procedures, and internal SOPs.
- In coordination with the Research Manager develops strategy and operational best practices for early phase clinical trials.
- Analyzes study monitoring and operational reports to monitor production and data collection events; evaluates progress towards meeting required timelines and data collection tasks.
- The incumbent decides how to best accomplish the daily requirements of various study objectives, prioritizes and delegates workload and establishes systems needed to achieve specific study goals. Efforts of multiple departments or disciplines must be coordinated to ensure effective follow through and compliance of all involved.
- The incumbent functions independently under minimal supervision, following FDA, Good Clinical Practice, IRB, NIH, NCI, NSF and/or other regulatory agency guidelines and seeking council from the Principal Investigator or manager as necessary.
- Implements procedures to prevent future events, including staff education and retraining.
- Prepares for and coordinates site visits made by sponsors or federal agencies during course and at the close of the study.
- May prepare, submit or maintain IRB, FDA, NCI, NIH, NSF and/or other regulatory documents and research correspondence for early phase trials.
- Assists in the selection and hiring process for study staff; mentors and trains new or junior research staff.
- Process specimens as required by study protocols, including after hours support. May require the need train other team members in these processes.
- Contributes to developing educational materials and educates the community and other research professionals regarding studies and related research issues.
- Develops training and staff certification materials, procedures and requirements. Assists the PI in development of materials and tools necessary to appropriately train individuals involved in the conduct of the study.
- Helps develop applicable data management queries and oversees data cleaning activities.
- Evaluates new protocols for feasibility and workflow considerations.
- Thoroughly reviews study protocols and maps process and data flow to predict areas of vulnerability. Identifies, recommends and implements solutions to address such vulnerabilities in specific trials and across the team’s study portfolio.
- Assists in the development of case report forms.
- Develops QA/QC processes and conducts quality control activities (field/study visits, data queries).
- Works with data managers to help design, develop and test appropriate informatics tools to meet study data, participant and sample tracking needs.
- Helps to develop standard operating procedures.
- Compiles information for grant applications.
- Participates in abstract and manuscript preparation.
Disclaimer This job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.
Physical Requirements and Level of Frequency that may be requiredNearly Continuously: Hearing, listening, talking.Often: Repetitive hand motion (such as typing), walking, standing, sitting. Seldom: Bending, reaching overhead. The staff member must be able to demonstrate the knowledge and skills necessary to provide care appropriate to the age of the patients served on his or her assigned unit. The individual must demonstrate knowledge of the principles of life span growth and development and the ability to assess data regarding the patient’s status and provide care as described in the department’s policies and procedures manual.
Minimum Qualifications
Bachelor’s degree in a health science or related field or equivalency (one year of education can be substituted for two years of related work experience); plus, 4 years professional research experience and completion of University RATS Clinical Certification within one year of hire required. Exceptional organizational skills, attention to detail, and demonstrated human relations and effective communication skills also required.
Knowledge of Good Clinical Practices, FDA, HIPAA and IRB regulations; an understanding of research procedures; and the ability to function independently is preferred.
Departments may require IRB CITI Course or IATA DGR training within a specified timeframe.
Departments may prefer a nursing degree for this position, which requires the incumbent to have two years related experience and possess a nationally recognized research compliance certification.
This position is patient-sensitive and must fulfill all associated requirements. We protect our patients, coworkers and community by requiring all patient-sensitive employees to be immunized according to CDC standards and hospital policy. Limited exemptions may be made for documented medical contraindications or religious beliefs that object to vaccinations.
Care is appropriate to the population served
Applicants must demonstrate the potential ability to perform the essential functions of the job as outlined in the position description.
Preferences
- Working knowledge of pediatric hematology/oncology clinical trials
- Laboratory experience processing tissue samples
- Credentialing as a Certified Clinical Research Coordinator (CCRC), Certified Clinical Research Professional (CCRP), or other related certification.
Special Instructions
Requisition Number: PRN38183B
Full Time or Part Time? Full Time
Work Schedule Summary: Monday-Friday from 8am-5pm
Department: 00848 - Pediatric Administration
Location: Campus
Pay Rate Range: $47,600 - $84,249
Close Date:
Open Until Filled: Yes
To apply, visit https://utah.peopleadmin.com/postings/162924
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