Clinical Research Manager - Obstetrics and Gynecology

SummaryManage all aspects of gynecological oncology clinical trial initiatives to ensure compliance with state, federal and institutional regulations, policies and procedures.Primary ResponsibilitiesAct as a resource for investigators and support staff on pre-trial functions including budget development, contract negotiations and IRB applications. Advise department study investigators and support staff on administrative and regulatory aspects of human subject research.Develop and implement department policies, procedures and organizational tools to ensure compliance with MCW, state and federal standards.Manage data systems supporting research activities. Correspond with IRBs as needed.Assist in the development and management of budget.Recruit and train clinical research staff nurses and/or clinical research coordinators; develop and implement standardized expectations for all subordinates; assess, monitor and evaluate work load and performance. Mentor and direct staff to achieve research goals.Coordinates planning, feasibility, and implementation of new protocols with research nurses, investigators, and multidisciplinary study teams.Maintains unit staffing needs by developing, implementing, and revising a staffing plan which assures efficient and effective delivery of participant care and facilitation of research studies during regular and after-hours clinical research visits.Under physician direction, perform protocol-specific clinical tasks including patient assessment, screening, ordering tests, collecting specimens, and monitoring responses. May administer medication or other types of protocol specific intervention.Act as a liaison between Department Administrator and research staff. Work closely with other departments and external agencies to advance the department’s research goals.Develop, implement and monitor department research QI activities. Implement and conduct quality control processes to ensure the highest data and research standards.Develop clinical review data review plan and check specifications. Utilize quality improvement tools & statistical process control to facilitate improvement of systems & processes.Other duties as assigned.Knowledge – Skills – AbilitiesKnowledge of biology, clinical judgment, medicine, cultural awareness, and consulting.Medical documentation, interpersonal, practice-based learning and improvement, empathy, and decision making skills.Forward and innovative thinking.QualificationsAppropriate experience may be substituted for education on an equivalent basis.Minimum Required Education: Bachelor’s degree.Minimum Required Experience: 6 yearsPreferred Education: Master of ScienceRequired Certification/Licensure(s): Wisconsin RN License. CCRC or CCRP required. CITI training required within 90 days of hire.Physical RequirementsWork requires occasionally lifting moderate weight materials, standing, or walking continuouslyWork EnvironmentOccasional exposure to dust, noise, temperature changes, or contact with water or other liquids. Work is performed in an environmentally controlled environmentSensory AcuityAbility to detect and translate speech or other communication required. May occasionally require the ability to distinguish colors and perceive relative distances between objects.#LI-AV1Why MCW?Outstanding Healthcare Coverage, including but not limited to Health, Vision, and Dental. Along with Flexible Spending options403B Retirement PackageCompetitive Vacation and Paid Holidays offeredTuition ReimbursementPaid Parental LeaveEmployee & Family Assistance Program (EFAP)Pet InsuranceOn campus Fitness Facility, offering onsite classesAdditional discounted rates on items such as: Select cell phone plans, local fitness facilities, Milwaukee recreation and entertainment etc.For a brief overview of our benefits see: Benefits OverviewFor a full list of positions see: MCW CareersAt MCW all of our endeavors, from our internal operations to our interactions with our partners, are driven by our shared organizational values: Caring – Collaborative – Curiosity – Inclusive – Integrity – Respect. We are committed to fostering an inclusive environment that values diversity in backgrounds, experiences, and perspectives through merit-based processes and in alignment with all applicable laws. We believe that embracing human differences is critical to realize our vision of a healthier world, and we recognize that a healthy and thriving community starts from within. Our values define who we are, what we stand for and how we conduct ourselves at MCW. If you believe in embracing individuality and working together according to these principles to improve health for all, then MCW is the place for you. For more information, please visit our institutional website.MCW as an Equal Opportunity Employer and Commitment to Non-Discrimination:The Medical College of Wisconsin (MCW) is an Equal Opportunity Employer. We are committed to fostering an inclusive community of outstanding faculty, staff, and students, as well as ensuring equal educational opportunity, employment, and access to services, programs, and activities, without regard to an individual's race, color, national origin, religion, age, disability, sex, gender identity/expression, sexual orientation, marital status, pregnancy, predisposing genetic characteristic, or military status. Employees, students, applicants or other members of the MCW community (including but not limited to vendors, visitors, and guests) may not be subjected to harassment that is prohibited by law or treated adversely or retaliated against based upon a protected characteristic. #J-18808-Ljbffr