Manager – Research Operations

Job Summary

The Manager, Research Operations is responsible for ensuring the compliance of the research program and associated research activities across the CHS enterprise. This includes coordinating the compliant implementation and conduct of projects involving human subjects during pre-award (e.g. budget preparation, study build in the Clinical Trial Management System, agreements, and Institutional Review Board submission) and post-award (e.g. amendments, continuing reviews and renewals, monitoring/auditing, and closures) phases. Scope may include oversight and management of sponsored research financial activities across the CHS enterprise. The successful incumbent will be detail-oriented and self-directed with demonstrated ability to work independently, yet establish cooperative relationships with colleagues.

Essential Functions

• Performs comprehensive review of new research submissions including sponsored trials, federal grants and special projects, with respect to institutional research policies and procedures, and regulations governing research involving human subjects. This includes review of Research Team training and credentialing, document review, conflict of interest review, feasibility review, budget review, protocol and informed consent form review, agreement preparation and review, and Oracle entry preparation.
• Monitors, tracks, and audits research activities across the CHS Enterprise for compliance with ethical, legal, financial, and reporting requirements. Prepares reports as needed. Assists Facility Research Staff with preparation for and response to audits.
• Communicates status of research activities and financials to facilities, Research Operations, and Corporate leadership.
• Develops and maintains knowledge of the CHS Research Program and associated activities to coordinate the comprehensive and compliant execution of protocols. Collaborates with Facility Research Staff to evaluate project protocols and study budgets.
• Facilitates onboarding and training of research support personnel and medical staff with respect to pre- and post-award activities, as well as research-related software platforms.
• Maintains awareness, training and compliance regarding research laws, regulations, and guidance, such as, but not limited to NIH, JCAHO, OSHA, FDA, HIPAA, OIG, IRB. Collaborates with institutional compliance efforts related to research matters to ensure completion of any audit support documentation.
• Maintains professional, collaborative working relationships, including frequent and open effective communication, with medical staff, other CHS departments/personnel, and outside organizations.
• Performs other duties as assigned.
• Complies with all policies and standards.

Qualifications

• Bachelor's Degree in Business Administration, Finance, Accounting, Science or a related field required or
• Associate Degree paired with an applicable certification and/or additional years of experience may be accepted in lieu of educational requirement required
• Other advanced degree in Health Care, Science or Business preferred
• 3-5 years of combined experience in coordination, management, administration of clinical trials, grants, and other sponsored programs in a hospital or academic setting required and
• 2-4 years of experience working with study budgets, including developing reports and presentation of information, and contract matters required
• 3-5 years of experience in auditing, project management, or process improvement, principles related to fair market value, clinical trial management systems, and/or Oracle; knowledge of Medicare billing and coding including CPT, HCPCS, ICD coding, and clinical research services billable to payers versus clinical trial sponsors preferred

Knowledge, Skills and Abilities

• Excellent written and verbal communication skills with a customer service focus.
• Ability to handle multiple activities simultaneously, and effectively prioritize tasks and responsibilities to ensure deadlines are met.
• High level of attention to detail and accuracy.
• Ability to develop educational presentations and public speaking, as well as write policies, guidance documents, and/or standard operating procedures.
• Must possess discretion and mature judgment with regard to confidential information.
• Ability to understand and interpret scientific and medical dialogue and text.
• Intermediate computer proficiency with Microsoft Office Suite, Google Suite, and Clinical Trial Management Systems.

Licenses and Certifications

• CHRC - Certified in Healthcare Research Compliance preferred or
• CCRP - Certified Clinical Research Professional preferred or
• CCRC - Certified Clinical Research Coordinator preferred