Job Summary:
UW Clinical Trials Institute is a partnership between the University of Wisconsin School of Medicine and Public Health (SMPH) and UW Health. It supports clinical research professionals, investigators, and participants to advance discovery and research in the prevention, detection, and treatment of disease to help improve the health of individuals, families, and communities across Wisconsin and beyond. Our exceptionally talented and diverse workforce provides care, support, and information to clinical trials participants; resources, training, and guidance to research professionals; and opportunities for industry partners to advance groundbreaking medical research.
Supporting the mission and vision of the UW CTI, the Director of Clinical Trials Implementation and Coordination will manage clinical trials study activation and coordination across the UW Health and UW-Madison enterprise. They will provide oversight and management to the Portfolio Management Team, providing start-up management, and the clinical research coordinator teams providing study implementation and coordination services across the enterprise. Working directly with investigators and staff, they will ensure the appropriate use of resources, and the management of efficient study work. The Director of Clinical Trials Implementation and Coordination will work with senior leadership on strategy for the research portfolio and will ensure an adequately trained and staffed team to complete required study activities. They will be the primary contact with Principal Investigators (PIs) ensuring that studies are being completed on time and on budget and will work across the organization to mitigate potential compliance or implementation challenges.
The Director of Clinical Trials Implementation and Coordination will serve as a content expert resource to PIs, study coordinators and other research staff with regard to study-specific protocol requirements and problem solving related to clinical, logistical, financial, and regulatory issues. They will maintain strong collaborative relationships with ancillary services, UW Health Nursing, UW Health Lab and operational staff in the clinics and hospitals in which we work. They will further work to ensure a research culture that encourages compliance, collaboration, efficiency and professionalism among all staff.
The incumbent should possess excellent time management skills, ability to work collaboratively, manage multiple projects despite interruptions, while closely tracking details and looking for ways to improve processes, have advanced communication skills, the ability to interface with multiple parties with competing interests, and demonstrated ability to work in multi-disciplinary teams.
Responsibilities:
Plans, develops, and directs a clinical research program within a division, center, or department.
Solicits clinical research opportunities, develops policies and procedures, and has significant responsibility for the overall functioning and effectiveness of the clinical research.
Supervises one or more Clinical Research Managers.
30% Plans staff implementation of protocols and on-going quality review of one or multiple highly complex clinical research trials or programs.
15% Analyzes research portfolios and accounts, solicits internal and external research opportunities, promotes unit capabilities, and makes recommendations to leadership for strategic program enhancements.
10% Compiles audits and documents research data to ensure necessary compliance with institutional policies and procedures.
20% Exercises supervisory authority, including hiring, transferring, suspending, promoting, managing conduct and performance, discharging, assigning, rewarding, disciplining, and/or approving hours worked of at least 2.0 full-time equivalent (FTE) employees.
5% Develops and monitors the program budget; and reviews and approves expenditures.
5% Drive and support strategic initiatives under the guidance of senior leadership to advance clinical research programs.
10% Provide project consultations, trial updates, and budgetary considerations, while also serving as a liaison to ensure strong internal and external relations.
5% Partner with training resources throughout the organization to establish a continuous education framework & training for clinical research coordinator & portfolio manager staff to ensure personnel are up-to-date and skilled.
Education:
Preferred: Bachelor's Degree
Qualifications:
Required:
Minimum 1 year of formal supervision of coordinators or project management staff.
Minimum 8 years' experience in clinical trials operations with experience that includes regulatory, coordination, project management and budget/contract negotiation.
Working knowledge of Good Clinical Practices (GCP) and current FDA regulations for clinical trials research.
Previous experience with OnCore, eBinders, Electronic Health Records (preferably Epic), and IRB applications.
Proven ability to train study coordination staff in efficient and effective clinical trials workflows.
Previous experience working with Contract Research Organizations and Industry Study Sponsors.
Preferred:
Experience with Device research.
Clinical Trials Certification, CCRC, CCRA or CCRP.
License/Certification:
Required: Drivers License - Valid and Meets UW Risk Management Standards. Travel is required. Must provide a valid driver's license. Employees may use their own transportation or receive approval for University Car Fleet usage. Employment is conditional pending the results of a Pre-hire Driver Authorization Check.
Work Type:
Full Time: 100%. This position may require some work to be performed in-person, onsite, at a designated campus work location. Some work may be performed remotely, at an offsite, non-campus work location.
Appointment Type, Duration:
Ongoing/Renewable
Salary:
Minimum:
$116,426 ANNUAL (12 months) Depending on Qualifications. The starting salary for the position is $116,426 but is negotiable based on experience and qualifications.
Additional Information:
University sponsorship is not available for this position, including transfers of sponsorship. The selected applicant will be responsible for ensuring their continuous eligibility to work in the United States (i.e. a citizen or national of the United States, a lawful permanent resident, a foreign national authorized to work in the United States without the need of an employer sponsorship) on or before the effective date of appointment.
How to Apply:
To apply for this position, please click on the "Apply Now" button. You will be asked to upload a current resume/CV and a cover letter briefly describing your qualifications and experience, and a document listing contact information for three (3) references, including your current/most recent supervisor. References will not be contacted without prior notice.
Contact:
Rafael Veintimilla
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Official Title:
Clinical Research Director(RE017)
Department(s):
A53-MEDICAL SCHOOL/CLINICAL RESEARCH
Employment Class:
Academic Staff-Renewable
Job Number:
305127-AS
The University of Wisconsin-Madison is an Equal Opportunity and Affirmative Action Employer.
Qualified applicants will receive consideration for employment without regard to, including but not limited to, race, color, religion, sex, sexual orientation, gender identity, national origin, age, pregnancy, disability, or status as a protected veteran and other bases as defined by federal regulations and UW System policies. We promote excellence through diversity and encourage all qualified individuals to apply.
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