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Senior Clinical Research Specialist

Fairview Health Services

This is a Contract position in Los Angeles, CA posted July 31, 2022.

Overview: The Senior Clinical Research Specialist position is responsible for implementing and managing the processes necessary to support the compliant conduct of research throughout the Fairview system.

Specific areas of focus and responsibility include: systematic review and analysis of all clinical trials taking place within M Health Fairview system, assuring that complex clinical trials are in accordance with federal regulations, policies and procedures to reduce both institutional and individual provider legal and financial risk (including investigational drug and device research protocols); developing and communicating system-wide policies and procedures, implementing administrative/operational improvements, translating and applying various regulatory requirements (including CMS, FDA, HIPAA and OHRP), providing oversight and quality assurance for compliance purposes, educating and training research partners, and participating in ongoing general research support to the system.

Manages conflict of interest annual review for researchers, establishing management plans when appropriate.

Facilitates compliance with necessary collaborating offices, such as Institutional Review Board, Patient Privacy, and Investigational Drug Services Pharmacy), partnering and representing research with multiple stakeholders across Fairview Health Services and the University of Minnesota.

Responsibilities/Job Description: Provides research partners with guidance, information, and assistance in complying with system operations, policies, and processes related to research.

Encourage the use of diversity within research protocols to achieve HOPE Commission academic goals.Provides research billing compliance guidance and oversight.Collaborates with research partners on protocol development, completion of IRB applications, crafting consent forms and HIPAA authorizations, and communicating with the IRB and sponsors.Conducts annual research conflict of interest annual assessment with Fairview researchers, including tracking, review, and development of conflict of interest management plans.

Ensures research investigational drug and investigational device regulations are implemented and followed.Assists in the development and implementation of training and education programs for a variety of internal and external researchers to ensure system-wide research processes knowledge is disseminated.Utilization and management of databases, including clinical trial management and electronic medical record systemsTracks and assist in ensuring compliance with federal, state, and local regulations and requirements for research.Develop policies, create company procedures for complying with new regulations or requirementsManage implementation of policies and proceduresEstablish best practices for compliant researchProvides research support and act as liaison between researchers and clinical teams, including lab, imaging, and pharmacy.Organization Expectations, as applicable: Demonstrates ability to provide care or service adjusting approaches to reflect developmental level and cultural differences of population served.

Partners with patient care giver in care/decision making.Communicates in a respective manner.Ensures a safe, secure environment.Individualizes plan of care to meet patient needs.Modifies clinical interventions based on population served.Provides patient education based on as assessment of learning needs of patient/care giver.Fulfills all organizational requirements.Completes all required learning relevant to the role.Complies with and maintains knowledge of all relevant laws, regulation, policies, procedures, and standards.Fosters a culture of improvement, efficiency, and innovative thinking.Performs other duties as assigned.

Qualifications: RequiredEducationBachelor’s Degree in related fieldExperienceFour years clinical research experience with one-year regulatory experience.PreferredEducationBachelor’s degree in healthcare related field, additional training or education in healthcare administration or research.ExperienceFive or more years of clinical research experience in an academic setting; in addition, two years of regulatory experience.License/Certification/RegistrationNursing license (RN or LPN), Research Certification (CCRC, CCRA, etc.).Additional Requirements (must be obtained or completed within a period):Knowledge of Microsoft ApplicationsExperience with Epic, preferred.Experience with OnCore, clinical trial management systemKnowledge of Institutional Review Board regulationsKnowledge of Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines