Director, Clinical Trials Implementation & Coordination

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 provide 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 skilledInstitutional Statement on Diversity:Diversity is a source of strength, creativity, and innovation for UW-Madison. We value the contributions of each person and respect the profound ways their identity, culture, background, experience, status, abilities, and opinion enrich the university community. We commit ourselves to the pursuit of excellence in teaching, research, outreach, and diversity as inextricably linked goals.The University of Wisconsin-Madison fulfills its public mission by creating a welcoming and inclusive community for people from every background - people who as students, faculty, and staff serve Wisconsin and the world.For more information on diversity and inclusion on campus, please visit: Diversity and InclusionEducation:PreferredBachelor's DegreeQualifications: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 SponsorsPreferred:- Experience with Device research- Clinical Trials Certification, CCRC, CCRA or CCRPLicense/Certification:RequiredDrivers License - Valid and Meets UW Risk Management StandardsTravel 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. See https://businessservices.wisc.edu/managing-risk/driver-authorization-and-insurance/driver-authorization/#become-authorized-driver (click on 'Become an authorized driver' then click on 'Required criteria').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/RenewableSalary:Minimum $116,426 ANNUAL (12 months)Depending on QualificationsThe starting salary for the position is $116,426 but is negotiable based on experience and qualifications. Employees in this position can expect to receive benefits such as generous vacation, holidays, and sick leave; competitive insurances and savings accounts; retirement benefits. Benefits information can be found at (https://hr.wisc.edu/benefits/).SMPH Academic Staff Benefits flyer: (https://uwmadison.box.com/s/r50myohfvfd15bqltljn0g4laubuz7t0Additional 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. This position is an ongoing position that will require continuous work eligibility. UW-Madison is not an E-Verify employer, and therefore, is not eligible to employ F1 STEM OPT Extension participants. If you are selected for this position you must provide proof of work authorization and eligibility to work.This position has been identified as a position of trust with access to vulnerable populations. The selected candidate will be required to pass an initial caregiver check to be eligible for employment under the Wisconsin Caregiver Law and every four years.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. Your cover letter should address your qualifications as they pertain to the required job qualifications, along with any relevant preferred qualifications and interests and goals.Contact:Rafael Veintimillaveintimilla@wisc.edu608-890-4157Relay Access (WTRS): 7-1-1. See RELAY_SERVICE for further information.Official Title:Clinical Research Director(RE017)Department(s):A53-MEDICAL SCHOOL/CLINICAL RESEARCHEmployment Class:Academic Staff-RenewableJob Number:305127-ASThe 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. For more information regarding applicant and employee rights and to view federal and state required postings, click hereIf you need to request an accommodation because of a disability, you can find information about how to make a request at the following website: https://employeedisabilities.wisc.edu/disability-accommodation-information-for-applicants/Employment may require a criminal background check. It may also require you and your references to answer questions regarding sexual violence and sexual harassment.The University of Wisconsin System will not reveal the identities of applicants who request confidentiality in writing, except that the identity of the successful candidate will be released. See Wis. Stat. sec. 19.36(7).The Annual Security and Fire Safety Report contains current campus safety and disciplinary policies, crime statistics for the previous 3 calendar years, and on-campus student housing fire safety policies and fire statistics for the previous 3 calendar years. UW-Madison will provide a paper copy upon request; please contact the University of Wisconsin Police Department.