PS Manager, Clinical Research (PRN27572B)

PS Manager, Clinical Research (PRN27572B)
Under minimal supervision, responsible for planning, organizing, directing and/or controlling all aspects pertaining to clinical research operations within the Dept. of Neurosurgery with a particular emphasis on neurotrauma and critical care research. Responsibility for internal and external customer service, human resource and financial management operations, standardization, statistical analysis, monitoring clinical trials, and development and completion of clinical studies. Acts as a catalyst between the department and its customers and staff to ensure continuity and quality of service and care.
Our clinical research enterprise is growing rapidly with a significant number of exciting opportunities and we're looking for someone with research management experience to lead the team and help guide the operations to ensure we not only grow quickly but also smartly and effectively.
This position is considered Category I: Mandatory and required on campus or health care facilities to support on-site operations. Employees hired into this category will be required to be physically located at the Clinical Neurosciences Center if they are healthy and without COVID-19 symptoms for a significant, if not a majority, percentage of their time. Some remote work may be possible depending on operational needs

University of Utah Job ID# PRN27572B 00268 - Neurosurgery

COMPENSATION: 65,000 to 85,000

WORK SCHEDULE: Full Time (Usual schedule is Mon-Fri 8-5; some evening/weekend hours may be required as per some studies' needs.)

RESPONSIBILITIES:
The Clinical Research Manager will supervise, mentor, train, and provide backup for a team of Clinical Research Coordinators, Study Coordinators and research volunteers ensuring the effective and efficient completion of the team's responsibilities such as:

1. Overseeing compliance to protocol; manages quality control, completion and submission of study related documentation; prepares reports for organizations and agencies.
2. Developing study budgets; monitoring budget expenses and billing for allied services; negotiating payment schedule with sponsor and fees for internal services.
3. Monitoring enrollment goals and initiating strategies to promote enrollment and participant compliance. Coordinating and performing responsibilities related to research participants including determining subject population availability, developing informed consents and screening materials, screening and recruiting subjects, scheduling visits, obtaining informed consent, answering subject inquiries, overseeing study visits and acting as a liaison between participants and study-related parties.
4. Recognizing, tracking and reporting adverse events and protocol deviations.
5. Preparing for and coordinating site visits made by sponsors or federal agencies during course and at the close of the study.
6. Representing the research program at meetings, national and international research consortia.
7. Preparing, submitting and maintaining IRB, FDA, NCI, NIH, NSF and/or other regulatory documents and research correspondence.
8. Contributing to developing educational materials and educating the community and other research professionals regarding studies and related research issues.
10. Coordinating with referring physicians to provide information regarding available research projects and to maintain a strong referral basis.
11. Developing and maintaining patient databases, investigational logs and records of drugs administered, medical devices monitored and/or procedures followed.
12. Assisting the Principal Investigator in the development of study protocols.
Departments may require IRB CITI Course or IATA DGR training within a specified timeframe.

This job description 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.

Work Environment and Level of Frequency that may be required

Nearly Continuously: Office environment.

Physical Requirements and Level of Frequency that may be required

Nearly Continuously: Sitting, hearing, listening, talking.

Often: Repetitive hand motion (such as typing), walking.

Seldom: Bending, reaching overhead.

QUALIFICATIONS:

Bachelor's degree in a related area or equivalency (2 years related work experience may be substituted for 1 year of education). Four to six years of progressively more responsible management experience. Background knowledge of hiring department's area of specialization in order to analyze, plan and draw conclusions for recommendations to superiors. Demonstrated leadership skills in planning and directing employees and processes in order to effectively monitor and develop subordinates and to ensure the smooth operation of department. Master's degree in a related area may be preferred.

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.

Applicants must demonstrate the potential ability to perform the essential functions of the job as outlined in the position description.

PREFERENCES: Familiarity with clinical research practices with an academic setting, preferably at the University of Utah.

TO APPLY, VISIT: https://utah.peopleadmin.com/postings/122246

EQUAL EMPLOYMENT OPPORTUNITY

The University of Utah is an Affirmative Action/Equal Opportunity employer. Upon request, reasonable accommodations in the application process will be provided to individuals with disabilities. Please contact the Office of Equal Opportunity and Affirmative Action, 201 S. Presidents Cr., Rm 135, (801) 581-8365 (V/TDD), for further information or to request an accommodation. The University of Utah is committed to diversity in its workforce. Women and minorities are encouraged to apply.