Clinical Research Manager

Overview:

Vitalief is partnering with our non-profit clinical cancer research center client in the Chicago area, to find a Clinical Research Manager that will direct the planning, coordination, and management of clinical trial activities and operations for the Cancer Center Clinical Trials Office (CC CTO). This will include administrative and fiscal oversight, regulatory compliance oversight, staff training and development, support of programs, and direction for processes and communications.  This position will also be responsible for the oversight of clinical research activities within the disease teams, managing approximately 20 employees (research nurses, clinical research coordinators and regulatory coordinators) in the overall conduct of clinical trials, as well as tracking and complying with clinical trial performance benchmarks, patient safety, and financial objectives.

Note:  Work location Maywood, IL (10 miles west of downtown Chicago)

Salary Range:  $100,000 to $135,000 annually (depending on experience level)

Responsibilities:

• Working with a Clinical Trial Office (CTO), manage the support of complex clinical trials (involving a very vulnerable and sick population) across the life cycle of the study, including study feasibility, regulatory compliance oversight, coordination of protocol review and approval, study initiation, operation and close out.
• Oversee clinical coordination of oncology clinical trials to ensure studies are completed on time, within budget and in compliance with the clinical trial protocol, standard operating procedures, FDA regulations and ICH/GCP guidelines.
• Consult, advise and meet with investigators for conducting clinical trials and assisting with development of protocols.  
• Receive and review invitations for research studies from industry sponsors, cooperative group agreements, investigator-initiated trials (IITs) and Clinical Research Organizations (CRO).
• Collaboration with the Institutional Review Board in ensuring regulatory compliance.
• Responsible for staff recruitment; develop, facilitate and support staff onboarding and development, including orientation, staff competencies, and continuing education.
• Ensure that the safety and welfare of human subjects are protected and that legal, privacy, and confidentiality measures are implemented. 
• Identify and address opportunities for improvement in conjunction with participating in the evaluation and development of goals and priorities for the Cancer Center Research Program that is consistent with the Health System’s mission and strategic goals.  

Required Skills:

• Bachelor’s degree from a four-year college or university, nursing and/or advanced degree. 
• 6 years of experience in clinical healthcare setting involving operations management, quality data/informatics, and/or healthcare systems implementation and training.
• 3 or more years of clinical trial experience, with a strong focus on training delivery and development. Must have experience working in a clinical research institution (as opposed to a Sponsor or CRO).
• Oncology experience is highly desirable (but not a requirement). Oncology nursing experience is a plus.
• Experienced in project management, clinical trial management-oversight, site management-monitoring, data management, pharma covigilance/drug safety, quality management, audits/regulatory agency inspections, and regulatory compliance.
• Strong verbal and written communication skills and ability to form cross functional leadership partnerships to accomplish goals.
• Organizational and time management skills. Collaborative, energetic, team-oriented professional who is comfortable with change.
• Experience working in a fast-paced and highly intense research environment.
• Specialty certification in a clinical or functional area of nursing granted by a national nursing organization is preferred (i.e., current Registered Nurse License State of Illinois, CCRA – Certified Clinical Research Associate, SOCRA or ACRP). 
• Advanced Microsoft office skills (Word, PowerPoint, and Excel); electronic medical record/EPIC and Clinical Trials Management System (e.g., Velos, OnCore) experience.

PHYSICAL DEMANDS: Standing, sitting, walking, visual perception, talking and hearing. Lifting up to 25lbs.

IMPORTANT NOTE: Vitalief partners with clients such as major medical centers and academic institutions that requires all on-site resources such as prospective Vitalief consultants to provide proof that they are fully vaccinated for Covid-19; inoculated annually for Influenza; and successfully pass a Mantoux Tuberculin Skin Test (TST) for Mycobacterium Tuberculosis.

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Salary : $100,000 - $135,000