Research Associate Senior
Aurora Health Care
Milwaukee, Wisconsin, United States
Job type: fulltime
Job industry: Science & Technology
How You'll Make a Difference:
Main purpose is the management of scientific, regulatory, and resource aspects of the organization's research authorization process. In addition, supports research initiatives by collaborates with investigators, residents, students, scientists, healthcare providers, fellows, and other research staff in the planning of studies, conducting projects, and disseminating findings. Promotes research collaboration on behalf of, and between, academic partners and Aurora Health Care.
Significant effort will be spent on the Research Administrative Pre-Authorization process (>50% effort). This process intakes around 200 research proposals per year, and the research associate will manage research guidance/feedback, provide suggestions for research improvement. The research associate will also focus on continual process improvement/updates, which includes writing/updating policies and procedures, as well as presentations at educational or quality meetings. May require significant time communicating results/recommendations with research teams.
Partners with the principal investigator(s) to design, develop, obtain Institutional Review Board (IRB) approval, implement and disseminate investigator initiated research. Serves as a primary developer of research protocols and facilitates study participant recruitment and biospecimen and data collection.
Creates or assists in the development and maintenance of research data collection tools, databases, and files to include data cleaning, data security, compilation and submission of data. Identifies, collects, tracks and disseminates study enrollments and protocol information. Prepares reports and extracts data from electronic health records as requested. Maintains confidential materials and records.
May schedule study participants participating in research projects for tests and procedures according to protocol design and sets up qualification, initiation and monitoring visits throughout the study, as needed.
Reviews subject medical records, database records and other sources to screen and identify potential subjects for inclusion in research projects based on criteria described in the protocol.
Facilitates, coordinates and successfully implements research projects, as needed, from conception through project definition, characterization of therapeutic areas, study design and planning, and dissemination of findings.
Collaborates with heath care professionals including various research staff to ensure projects are conducted in an ethical and safe manner according to Good Clinical Practice (GCP), standard operating protocols (SOPs), Institutional Review Board (IRB) policies and procedures, and regulatory standards.
Monitors project compliance and maintains a system for perpetuation of effective data flow. Processes highly confidential correspondence related to principal investigators, sub-investigators, industry, national cooperative groups, study subjects, clinical research staff and/or administrative staff. May interview and evaluate study participants to determine trial/project eligibility and disseminates information for enrollment on protocol once eligibility is confirmed. Coordinates data analysis and participates in manuscript writing.
Coordinates the collection and completes and submits data on appropriate documents according to the IRB, the Clinical Research Department's Standard Operating Procedures (SOPs), or regulatory policies, including routine data reporting, submissions, continuing reviews, amendments and adverse event reporting.
What it Will Take:
Licenses & Certifications
An MS (with research component) or PhD is preferred, and the minimum requirement is a Bachelor's Degree in a scientific or related field.
Required Functional Experience
Typically requires 5 years of experience in research including clinical, basic science or health outcomes research and applying research methods, project management and data management or equivalent in training and experience.
Knowledge, Skills & Abilities
Solid understanding of good research practices, methodologies, and ethics.
Ability to establish rapport with investigators, physicians, staff, and students and to work well within a team environment. Must be able to communicate well and build relationships during difficult conversations.
Ability to understand and communicate research design and protocol requirements to others.
Ability to conduct and manage studies in multi-site health services and human services research.
Ability to work with multiple stakeholders and constituencies at all levels in academic and health care settings.
Research Grants And Projects
945 N 12th St
At Aurora Health Care:
We pride ourselves on taking care of our people. And not just our patients-we mean you, too. We help each other live well. When you work at Aurora, you get the chance to work with a dedicated team that's as passionate about the work as you are. Here, you'll find limitless opportunities for ongoing learning, career advancement, competitive compensation and a stable work environment. But more than that, you have the opportunity to change lives-including your own.
Diversity and inclusion matters at Aurora. We celebrate our differences and nurture an environment where everyone feels included. We know that when we reflect the communities we serve, when we embrace differences and bring our whole selves to work every day, we are working as one to build a healthier tomorrow for everyone. Aurora supports a safe, healthy and drug-free work environment through criminal background checks and pre-employment drug testing. We maintain a smoke-free environment at all our locations. We are an equal opportunity employer.