Associate Director - Orthopedics

Associate Director of Clinical Research will direct and oversee the administrative, operational, fiscal, research and patient care activities of sponsored and internal clinical research studies in the Department of Orthopaedics; actively participates in planning, development and implementation of short- and long-range strategic planning activities, policies and procedures; collaborates with Department leaders, principal investigators and staff leadership to plan and implement activities to achieve organizational goals and objectives; disseminates plans and directives to research team to effectively and efficiently carry out the organization’s strategic activities to meet established goals and objectives; directs and oversees clinical research study budgets, developing and negotiating research study budgets with internal and external sponsors; actively participates in investigating and soliciting funding in support of clinical research; supports writing and preparation of grant proposals for extramural funding in support of research; directs and oversees recruitment, hiring, supervision, coaching and evaluation of clinical research staff; develops, encourages and provides ongoing education and professional development; directs and oversees drafting and submission of required regulatory documents related to human subject research; ensures protocols meet laboratory, specimen and processing requirements; serves as primary contact with Office of Responsible Research Practices, The Ohio State University Research Foundation, Institutional Review Board, and federal, national and industry sponsoring agencies for all issues; ensures compliance to all state, federal and industry policies, requirements and regulations of clinical research protocols.

Required Qualifications
Bachelor's degree in a biological or life science field, or other relevant area or an equivalent combination of education and experience required; Master's degree preferred; 5 years experience in a clinical research capacity conducting and implementing clinical studies required; 5 years experience in a research administrative or management capacity required; supervisory experience required; knowledge of clinical research regulatory rules, policies and processes at the local, state and federal levels required; ACRP or SOCRA certification preferred; knowledge of basic accounting practices and procedures desired; experience in writing research grants, applications and implementation preferred; understanding of clinical trials data management.

35% Directs and oversees clinical research study budgets, developing and negotiating research study budgets with internal and external sponsors; actively participates in investigating and soliciting funding in support of clinical research; supports writing and preparation of grant proposals for extramural funding in support of research.

35% Directs and oversees the administrative, operational, fiscal, research and patient care activities of clinical research; actively participates in planning, development and implementation of short and long-range strategic planning activities, policies and procedures; collaborates with SMRI leaders, principal investigators and staff leadership to plan and implement activities to achieve organizational goals and objectives; disseminates plans and directives to research team to effectively and efficiently carry out the Departments strategic activities to meet established goals and objectives.

25% Directs and oversees drafting and submission of required regulatory documents related to human subject research; ensures protocols meet laboratory, specimen and processing requirements; serves as primary contact with Office of Responsible Research Practices, The Ohio State University Research Foundation, Institutional Review Board, and federal, national and industry sponsoring agencies for all issues; ensures compliance to all state, federal and industry policies, requirements and regulations of clinical research protocols; oversees adherence to SOPs, Good Clinical Practice and FDA regulations; audits and evaluates study activities to identify non-compliance, deficiencies and quality improvement areas; determines and assigns actions to address problems with follow-up to ensure final resolution; plans, establishes and oversees new and/or revised policies, processes and practices to address quality assurance issues and to meet requirements of new research protocols; monitors and ensures compliance in the conduct of human subject research with University, state, federal, sponsor and industry rules, regulations, policies and procedures;

5% Directs and oversees recruitment, hiring, supervision, coaching and evaluation of clinical research staff; develops, encourages and provides ongoing education and professional development; collaborates with Department principal investigators to direct and coordinate medical student research projects; directs and oversees recruitment and management of clinical research volunteers.