SCOPE OF POSITION
This position reports to the Senior Director of Research Operations of OHRI. He/she will directly and independently manage the quality assurance programacross multiple regional sites and therapeutic areas in the Research Department. This position serves as a resource for other associates. He/She will carry out management responsibilities in accordance with the organizations policies, departmental standards and applicable laws. The Manager will lead, hire, direct, teach and manage direct reports and research personnel in OHRI ensuring quality and compliance within the department. Ensures that clinical trials and projects are initiated, documented and reported in compliance with internal SOPs, GCP guidelines, sponsor guidelines and current applicable regulatory regulations. Create and maintain an education and training program for OHRI Research Operations.
This position is critical for advancing OhioHealth’s investigator-initiated and scholarly research agenda which secures accreditation for key programs across thesystem (e.g., graduate medical education (GME), Level 1 trauma programs, Magnet Nursing designations, Osteopathic research requirements)). Effectively and efficiently aligns and deploys internal & external resources dedicated to investigator-initiated trials (IIT) across the system. Ensures standards are met for scientifically valid academic and other investigator-initiated research. Safeguards OhioHealth Corporation and human subjects of research through direction ofthe OHC internal IRBs. Officer (Vice-Chairman) of OHC Academic Research Council.
Education, Certification, Registration, License
RPH - Registered Pharmacist
Field of Study: Medical
Field of Study: life'sciences
Field of Study: epidemiology
Field of Study: public health
Field of Study: biology
Years of Experience: 5+
Advanced degree (MS; PhD; PharmD) in a medical and or life sciences research oriented degree, e.g. epidemiology, public health, biology, pharmacy Knowledge of clinical research and epidemiologic methodology, biostatistics, statistical software, federal human subjects research regulations (Dept. of Health and Human services, Food and Drug Administration, HIPAA). superior writing and oral communication skills. Budgeting and resource planning. Medical Education, Magnet Nursing and Level 1 Trauma accreditation requirements as they pertain to research. Design, conduct, analysis of clinical trials and other clinical research (5+ years). Manuscript development and publication (5+ years); research grant application development (5+ years); research administration & staff management (5+ years); and experience working collaboratively with physicians, nurses and other clinical leaders (5+ years).