Associate Director - Orthopedics

The Ohio State University

2d • Onsite

About The Position

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

Requirements

• Bachelor's degree in a biological or life science field, or other relevant area or an equivalent combination of education and experience required.
• 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.
• Understanding of clinical trials data management.

Nice To Haves

• Master's degree preferred.
• ACRP or SOCRA certification preferred.
• Knowledge of basic accounting practices and procedures desired.
• Experience in writing research grants, applications, and implementation preferred.

Responsibilities

• 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 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 the research team to effectively and efficiently carry out the Department’s strategic activities to meet established goals and objectives.
• 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.
• 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.

Benefits

• Medical, dental and vision coverage, with Ohio State paying a significant portion of the cost.
• Paid time off, including sick and vacation time and 11 holidays.
• State retirement plan or an alternative retirement plan, both with generous employer contributions.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager