SHIFT: No Weekends
Cannon Development Innovations is
a full-service contract research organization (CRO) that is uniquely
focused in oncology. Sarah Cannon Innovations offers strong scientific
leadership, access to patients through Sarah Cannon Research Institute’s Site
Management Organization (SMO) and relationships with other clinical sites, and
experience in drug development and delivery of clinical trials from
First-In-Man through registration level studies, making us the partner of
choice for oncology.
Our differentiator is strong operational delivery
in partnership with our Site Management Organization and physician leaders to
deliver your program efficiently.
Sarah Cannon Development Innovations works with
Sarah Cannon Research Institute strategic and network sites throughout the
United States, along with investigators at sites outside of the Sarah Cannon
Research Institute network. This reach allows Sarah Cannon Development
Innovations to offer sponsors access to a diverse and varied patient
population, spanning multiple tumor types and disease stages. These
relationships further enhance the depth and breadth of Sarah Cannon Development
Innovations’ therapeutic expertise, enabling it to provide focused, strategic
operational support. This support ensures that clinical trials are conducted in
a timely manner and reported with high-quality, registration-standard data.
Summary of Key Responsibilities:
Responsible for the hiring, development and supervision of the
Clinical Project Associate team within Sarah Cannon Development
Innovations. This role includes the
development and maintenance of procedures and departmental processes to ensure
ongoing compliance with federal, local and company regulations as well as Good
Clinical Practices to ensure adequate delivery of Industry Sponsored and Investigator
Initiated clinical trials. This role is also responsible for line management
within this department. The Manager, Clinical Affairs will follow standard
operating procedures, ICH-GCP, and all applicable regulatory requirements.
Duties and Responsibilities:
Duties include but are not
and oversight of the Clinical Project Associate team’s activities, ensuring compliance
with applicable regulations and Sarah
the performance of direct report colleagues, including role expectations and
adequate support, trouble shoot performance issues, and identify and develop
training opportunities for department and individuals
educate, direct and support the Clinical Project Associate Team
and define career development pathways for the Clinical Project Associate
Team to ensure stabilization and minimization of staff turnover
resources to ensure all project teams are adequately supported, including
forecasting, hiring and training
departmental resources to ensure department meets minimum utilization
in the development of tools for tracking study specific and departmental
health metrics that may be shared with clients as well as Senior Management
within Sarah Cannon
and write appropriate SOPs and working practice guidelines
strong relationships with managers of other functional groups within Sarah Cannon Innovations to ensure adequate
support, trouble shoot performance issues, and help project teams deliver on
with other Sarah Cannon groups to optimize processes and
achieve highest possible efficiencies
of the Clinical Leadership team responsible for overall performance of the department
in educational activities and programs
related work as required
- Practices and adheres to the
“Code of Conduct” philosophy and “Mission and Value Statement”
- During your employment with Sarah
Cannon you will be routinely assigned training requirements. You are
expected to complete any training assignments by the due date.
- Knowledge: A body of information needed to perform a tasks; May be obtained through education,
training or experience
- Detail-oriented with knowledge of scientific, medical, and regulatory terms.
- Knowledge of ICH Guidelines, GCP, and FDA regulations.
- Understanding of the drug/device development process
- Skills: The proficiency to perform a certain task
- Computer skills, including MS Word, Excel, Outlook, and PowerPoint; ability to learn new
software if required
- Professional writing and communication skills
- Abilities: An underlying, enduring trait useful for performing duties
- Ability to multi-task in fast paced environment is essential.
- Ability to function in a team environment under time and resource pressures.
- Ability to manage, organize, and make decisions.
Minimum Required: High School Diploma (GED)
Preferred: Bachelor's College Degree (4 yr program)
least 4 years experience in a clinical research environment
- Experience as a Clinical Project Lead or Clinical
Research Associate with demonstrated leadership skills
- Previous line management experience
HCA Healthcare ranks on
Fortune’s list of Most Admired Companies for three consecutive years and HCA
ranks 63rd on the fortune 500 list. In addition Ethisphere named HCA as one of
the World’s Most Ethical Companies. We want you to join our tradition of
excellence. Intrigued? We’d love to hear from you.
If you find this opportunity
compelling, we encourage you to apply. We promptly review all applications. If
you are highly qualified you will hear from one of our practice managers. We
are actively interviewing so apply today!
We are an equal opportunity
employer and value diversity at our company. We do not discriminate on the
basis of race, religion, color, national origin, gender, sexual orientation,
age, marital status, veteran status, or disability status.