Job Description

University of Utah Job Description

Job Summary

Coordinates complex clinical trial activities and plays a critical role in the conduct of multiple research studies

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.

 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.

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.

Essential Functions

1. Oversee, assess and ensure participant safety and strict protocol implementation/adherence; oversee compliance with GCP guidelines, federal regulations, institutional policies and procedures, and internal SOPs.
2. Develop study budgets; monitor and billing; negotiate payment schedule and fees with sponsor.
3. Evaluate processes to identify obstacles to successful recruitment and retention of study participants. Recommend and implement innovative approaches to maximize enrollment and optimize subject retention.
4. Analyze study monitoring and operational reports to monitor production and data collection events; evaluate progress towards meeting required timelines and data collection tasks.
5. Implement procedures to prevent future events, including staff education and retraining
6. Prepare for and coordinate site visits made by sponsors or federal agencies during course and at the close of the study.
7. Represent the research program at meetings, national and international research consortia.
8. Prepare, submit and maintain IRB, FDA, NCI, NIH, NSF and/or other regulatory documents and research correspondence
9. Assist in the selection and hiring process for study staff; supervise, mentor and train new or junior research staff; provide direction and oversee preparation of study staff for monitoring visits; manage staff schedules ensuring shift/studies are covered; approve requests for time off/approve KRONOS.
10. Contributes to developing educational materials and educates the community and other research professionals regarding studies and related research issues.
11. Develop training and staff certification materials, procedures and requirements.  Assist the PI in development of materials and tools necessary to appropriately train individuals involved in the conduct of the study.   Oversee and train team members across the entire spectrum of research studies to include, but not limited to: protocol requirements, schedule of visits, recruitment plan, execution of research plan, collecting adverse event information, maintaining study subject documentation.  Maintain records and other documentation of training.
12. Helps develop applicable data management queries and oversees data cleaning activities.
13. Determine subject population availability, develop recruitment,  informed consents and screening materials; help develop survey and study data collection instruments
14. Evaluate new protocols for feasibility.  Thoroughly review study protocols and map process and data flow to predict areas of vulnerability. Identify, recommend and implement solutions to address such vulnerabilities in specific trials and across the team’s study portfolio.
15. Coordinate approval of new study agreements and contracts; assists in the development of case report forms.
16. Develops QA/QC processes and conduct quality control activities (field/study visits, data queries)
17. Determine study visit and site/clinic work flows for studies/protocols
18. Works with data managers to help design, develop and test appropriate informatics tools to meet study data, participant and sample tracking needs
19. Helps to develop standard operating procedures
20. Compiles information for grant applications
21. Participates in abstract and manuscript preparation.

Problem Solving

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 as necessary.

The incumbent is expected to closely monitor use of experimental equipment and drugs. Because some subjects referred to participate on a research study have no other option for recovery, the incumbent must be aware of the subjects condition, well informed in the use of study material (devices, equipment, etc.) and conscientious in his/her analysis of appropriate actions.

The incumbent is responsible to organize coverage when not present to ensure protocol requirements are followed.

Comments

Work Environment and Level of Frequency that may be required:

Nearly Continuously: Office environment.

Seldom: Infectious disease, oils (there is air or skin exposure to oils or other cutting fluids).

Physical Requirements and Level of Frequency that may be required

Nearly 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.