Manager-Clinical Research - Cincinnati, United States - cchmc

Description

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Expected Starting Salary Range:

SUBFUNCTION DEFINITION:

The healthcare science that determines the safety and effectiveness (efficacy) of medications, devices, diagnostic products and treatment regimens intended for human use.

These may be used for prevention, treatment, diagnosis or for relieving symptoms of a disease. To ensure quality, human subject safety and data integrity of clinical trials conducted within the assigned department.


Scope:
10+ direct/indirect reports OR enterprise wide responsibilityJOB RESPONSIBILITIES Clinical OperationsSupport patient care delivery for their area as needed. Provide charge/shift leadership duties as appropriate for their work area.

Act as a liaison with in their area and amongst other departments and services to promote safe, quality patient care.

Grant AdministrationCoordinate grant and IRB submissions. Work with appropriate grants officers and business offices to manage all grant activities, pre award and post award. People PlanningManage the selection, development, motivation, appraisal and discipline personnel. Ensure that job requirements and goals for each position are clear to employees. Delegate responsibilities to reporting personnel, establish clear lines of responsibility and accountability. Determine and document the qualifications and competence of division personnel. Ensure that orientation, in-service training and continuing education are provided to division personnel. ComplianceMay define process and manage invention reporting required for federal and private compliance. Update Standard Operating Procedures (SOPs) as required when regulation and system changes dictate.

Collaborate to capture revenue distribution models for executed agreements to ensure that financials are distributed in compliance with the CCHMC policy.

Identify opportunities on an ongoing basis to improve compliance with agreement obligations, including milestones, reporting, and invoicing.

Strategic PlanningAssess feasibility of implementation of newly approved, pilot, or proposed research studies (resource allocation as well as clinical preparation).

Act as liaison between the research staff, and the industry sponsors, IRB, federal, state, and other regulatory agencies. Serve as a key resource to research participants and collaborators (referring institutions).

Expand knowledge base and remain abreast of new research developments by attending continuing education meetings, lectures, training sessions and conferences.

Implement this knowledge into the appropriate division/department within Cincinnati Children's Hospital Medical Center. Continuously update knowledge of regulatory issues regarding the conduct of clinical studies. Represent Division on hospital-wide councils/committees/working groups. Assist in the planning, design, measurement, assessment and improvement of the division's services.


Qualifications:

EDUCATION/EXPERIENCERequired:
Bachelor's degree in a related field 5+ years of work experience in a related job disciplinePreferred:

ACRP or SOCRA certification or equivalentExperience coordinating FDA-regulated complex clinical trialsExperience managing study budgets and billing complianceExperience with training/onboarding of new staffStrong conflict resolution and critical thinking skillsExcellent communication skillsCincinnati Children's is proud to be an Equal Opportunity Employer that values and treasures Diversity, Equity, and Inclusion.

We are committed to creating an environment of dignity and respect for all our employees, patients, and families (EEO/AA).#J-18808-Ljbffr