is the research arm of HCA's global cancer enterprise. Focused on advancing therapies for patients, it is one of the world's leading clinical research organizations conducting community-based clinical trials in oncology, cardiology and orthopedics through affiliations with a network of more than 1,000 physicians across the United States and United Kingdom.
We believe our success is dependent on a healthy work environment where staff members are the core of advancing therapies for patients and accelerating drug development. We apply the same compassion and commitment we have for our patients to our co-workers and colleagues and promote an entrepreneurial culture. GENERAL SUMMARY OF DUTIES
- The Director of Clinical Research is responsible for overseeing all aspects of HCA Midwest Health's clinical research program, including the hiring and developing of staff, implementing and managing departmental processes, and coordinating activities across all facilities to ensure that the clinical research program's growth objectives in terms of delivering planned revenues on an annual and long term basis are achieved. DUTIES INCLUDE BUT ARE NOT LIMITED TO:
- Oversee clinical trial-related activities completed / performed by the research staff to assure completeness and accuracy as well as adherence to federal and state guidelines.
- Problem solves clinical situations along with the research staff and the management team as they arise.
- Plans, facilitates, and presents trial management issues and data status updates at internal and external meetings.
- Provides oversight, leadership, and direction in the management and execution of trials.
- Assesses quality of data and performance of clinical trials and develops action plans to address performance gaps.
- Manages, monitors and operates within allowed budget
- Assesses organizational processes associated with trial execution and identifies ways to improve and streamline internal procedures
- Keeps executive team abreast of issues, progress, and risks related to trial operations
- Ensures internal process and Standard Operating Procedure (SOPs) are updated according to Good Clinical Practice (GCP) guidelines and ensure internal Quality Assurance standards and practices are in place
- Monitors industry trends and participates in educational activities as directed by Principal Investigators or other senior management
- Responsible for clinical research department goals, financial performance, quality assurance, oversight and patient enrollment
- Communicates to all stakeholders performance standards and expectations
- Implement and oversee the process of on-boarding and training new research sites
- Assess available research resources and facilitate those resources within each site
- Problem solves clinical situations along with research program members as they arise
- Assesses and ensure compliance with Quality and Regulatory department members
- Assists in development and tracking of quarterly goals for each site
- Works closely with site, sponsor/CRO monitors, and study managers to quantify the quality and timeliness of study data
- Assist with assuring ongoing research conduct at sites as needed
- Meets with physicians and administrators as needed to assess performance of site
- Monitors patient enrollment at sites through weekly reports
- Facilitates communication of site status to appropriate site/management personnel
- Representation of company vision to sites employees and affiliated organizations
KNOWLEDGE, SKILLS & ABILITIES
- Demonstrated analytical and detail oriented skills.
- Demonstrated computer proficiency and proficiency in PC applications as required.
- Demonstrated proficiency in organizational, project and time management skills.
- Proven ability to effectively interface with all types of people.
- Ability to establish and maintain long-term customer relationships, building trust and respect by consistently meeting and exceeding expectations.
- Ability to travel independently to collaborate with all system facilities.
- Ability to proactively prioritize needs and effectively manage resources.
- Ability to communicate clearly and concisely. Must have excellent verbal and written communication skills.
- Demonstrated knowledge and understanding of organizational policies, procedures, and systems.
- Ability to apply tools and processes to successfully manage to budget.
- Ability to assess work activities and allocate resources appropriately.
- Ability to understand complexities and needs to start-up and support new clinical trials.
- Bachelor's Degree in Business, Nursing or related field
- Minimum (5) years direct experience or related experience
- Experience in clinical research or similar service environments preferred.