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The Director of Clinical Research is charged with guiding the institute in maximizing the success of research conducted as well as increasing opportunities for growth. The Director works with the clinical research operational team to set direction and strategy for site activities. He/she also ensures that activities comply with federal, state, local and internal regulations, and standards.

Job Relationships

Reports to the VP & Chief Medical Office

Principal Responsibilities

• Directs, promotes, and supports high integrity, safe, compliant, and cost-effective clinical trial operations.
• Responsible for administrative activities associated with the conduct of clinical research including implementation of procedures (SOPs) and adherence to regulations.
• Directs research objectives and defines department goals to achieve those objectives.
• Implements best practices and standards for trial management in collaboration with other members of the team.
• Collaborates closely with Clinical Research Manager to ensure that clinical trials are properly resourced, managed and executed in accordance with timelines and good quality practices.
• Facilitates trial proposals, budgets and contracts with the PI, Finance & Legal teams.
• Builds relationships across all levels of an organization to meet business objectives.
• Develops and maintains relationships with study sponsors, research organizations, other external partners, as well as internal partners to promote study success.
• Generates business development activities to identify and secure new research opportunities.
• Coordinates activities and communication with Research Committee and prepares reports and strategies to upper-level management.
• Demonstrates the ability to effectively prioritize and execute tasks in a high-pressure environment.
• Adhere to all OSHA and Springfield Clinic training as required by policy.
• Provide excellent customer service and adhere to Springfield Clinic's Code of Conduct and Ethics Standards.
• Performs other job duties as assigned.

Education/Experience

• Master's degree preferred or a Bachelor's degree plus five years of relevant experience.
• Excellent project management skills.
• Strong Strategic Planning and Business management experience.
• Knowledge of industry standards and/or regulatory requirements.
• Strong written, oral, and interpersonal communication skills.

Licenses/Certification

• Research certification (CCRP, CCRC, CCRA) preferred.

Knowledge, Skills and Abilities

• Must provide own transportation to travel to all clinic locations.
• Excellent interpersonal, leadership, and organizational skills; a strong attention to detail with effective oral and written communication.
• Strong analytical and accounting skills with a strong knowledge of computer software including Windows, Word, Excel, Outlook, and PowerPoint.
• Must have the ability to lead and direct clinical research staff; work effectively with physicians, other providers, allied staff, and the senior team.
• Demonstrates the ability to effectively prioritize and execute tasks in a high-pressure environment.
• Must possess manual dexterity to handle equipment with the ability to lift/push/pull up to 50 lbs.
• Must have the ability to maintain composure under stress, using tact and good judgment with effective decision making.
• Must be able to stand and walk for long periods and capable of stooping, bending, and lifting.
• A strong working knowledge of GCP/ICH, FDA regulations, and HIPAA, as well as local and state laws and regulations regarding clinical research.

Working Environment

• Office based with travel to other Springfield Clinic locations (including satellite offices) and other business-related travel, as required to conduct day to day business aspects of the department.

PHI/Privacy Level

• HIPAA1