Research Support - Laboratory/Non-Laboratory, Staff/Administrative
Position Summary: The Research Professional 2 exists to support clinical research trials within the Department of Surgery, Clinical Trials Office. Responsibilities include patient recruitment, screening, consenting and perform study data collection and abstract data from medical records. This position requires completion of CITI training in biomedical research and Good Clinical Practice course along with individual study training required by sponsors. This position reports to the Clinical Trials Office Director, but is accountable to the Principle Investigator and members of the clinical research team.
Major Duties/Job Description:
Responsible for subject participation in research protocol: Recruit potential subjects Participate in protecting the rights of the research subject via execution of informed consent and compliance with HIPAA requirements Determine subject eligibility, and maintain compliance with protocol eligibility requirements. Collect, and ship specimens for research, laboratory, or clinical testing as required, often in repetitive and concise fashion to maintain integrity across all subject visits. Monitor subject responses to protocol defined treatments/interventions, and schedule required visits and tests. Evaluate laboratory and other findings to determine the presence of expected and unexpected subject reactions or outcomes Assess, troubleshoot, and report problems with data collection or other research processes. Obtain or confirm subject's consent to participate in research. Assess the subject's understanding of the research process, procedures and plan; implement and conduct subject and family education in response to identified needs. Under the supervision of the PI, report study/medical/test results for subjects and/or families and report significant findings to the appropriate study staff.
Coordinate communications between all individuals involved in research studies, (PI, co-PI, sponsor, monitor, clinical staff). Write routine correspondence for research projects including letters, memos, andInstructional study forms. Coordinate the successful implementation of the IRB approved protocol. Abstract data and fill out case report forms for research studies. Occasionally train and instruct others to use UMMC Fairview computer applications. Collaborate with other disciplines involved in the research process. Interact with study monitors. Assist with development of clinical research protocol documentation. Demonstrate effective and efficient communication with study sponsors, monitors, department and University staff. Maintain accurate and complete study records, supplies, and time keeping tools. Complete and maintain essential source documents, regulatory documents and case report forms. Report work time on an electronic time card. Update Subject Tracking Forms in the organization's business system. Perform research procedures for the collection of meaningful research data. In accordance with GCP and protocol, provide services, assessments, or interventions. Work with the investigational drug services for the administration of investigational medication. Assist the PI in reporting SAE’s and DSM reports.
All required qualifications must be documented on application materials.
Required Qualifications: A Bachelor's of Arts/Science degree in Health Sciences with two years of experience or an equivalent combination of education and experience to total six years. Experience must include at least 2 years of work experience in Clinical Trials involving investigational drugs/devices. Experience in the use of computer hardware and associated software. Demonstrated ability to work independently, make decisions, problem solve and prioritize the simultaneous management of multiple clinical studies. Possess excellent communication skills; verbal and written. Experience monitoring, managing and reporting Adverse Events Ability to work flexible work hours, including some early mornings, evenings, and weekends and on call as needed for studies.
Preferred Qualifications: Certified Clinical Research Coordinator (ACRP or SOCRA), strongly preferred EPIC navigation Experience with both in?patient and out?patient clinical trials Excellent interpersonal communication skills with patients and other healthcare professionals. Ability to follow strict protocols with utmost ethical standards.
Internal Number: 328563
About University of Minnesota, Twin Cities
The University of Minnesota, founded in the belief that all people are enriched by understanding, is dedicated to the advancement of learning and the search for truth; to the sharing of this knowledge through education for a diverse community; and to the application of this knowledge to benefit the people of the state, the nation, and the world.