Blue Ridge Cancer Care has an exciting opportunity for a FT Regulatory Affairs Project Coordinator for the Roanoke, VA location.
Blue Ridge Cancer Care is an affiliate of The US Oncology Network that extends an extremely competitive offering of benefits to employees, including Medical Health Care, Dental Care, Vision Plan, 401k, Life Insurance, Short-Term Disability, Long-Term Disability, Wellness and Perks Program.
Come join our growing organization and enjoy knowing that you work for an organization dedicated to making the lives of others better.
Under general supervision coordinates the research and administrative activities in support of projects for the Regulatory Affairs Department. Works with regional regulatory coordinators to maintain and coordinate the collection of critical documents. Supports and adheres to the US Oncology Compliance Program, to include the Code of Ethics and Business Standards.
ESSENTIAL DUTIES AND RESPONSIBILITIES: -Tracks sponsor-specific queries and resolutions. Works with Regional Regulatory Coordinators to obtain updated documents and/or resolve pending queries. -Assists in processing protocol amendments and/or consent form revisions for assigned trials. Responsible for ensuring new/updated regulatory documentation meets applicable regulations and is submitted to the pharmaceutical sponsor/contract research organization, and/or FDA in a timely manner. -Assists with study-related documents necessitating IRB review throughout the conduct of a trial (protocol amendments, continuing reviews, protocol deviations/exceptions). -Completes critical document collection instructions, as specified for new trials. Maintains and updates internal status log of critical and regulatory documentation completion. -Maintains study-specific and site regulatory files by filing and auditing existing regulatory documentation prior to regularly scheduled monitoring visits and audits. -Participates in early development meetings, conference calls, and discussions concerning the regulatory aspects of a trial in development until the trial is complete.
Bachelor's degree in a clinical or scientific related discipline preferred, and minimum three years related experience in a clinical research setting and/or regulatory affairs. Clinical Research certification (CCRA) preferred.
PHYSICAL DEMANDS: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to experience prolonged sitting, some bending, stooping and stretching. Requires eye-hand coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator and other office equipment. Requires normal range of hearing and vision correctable to 20/20. Requires occasional lifting of up to 30 pounds.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Work is performed in an office environment and requires frequent interaction with research staff, physicians, study sponsors and regulatory agencies. Work will require some travel by air or automobile, approximately 15% of time.
The US Oncology Network is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability or protected veteran status.
Internal Number: MCKEA00878001
About US Oncology Network
The US Oncology Network believes local cancer care is better care. We empower the delivery of advanced integrated cancer care through our network of independent physicians who share expertise and resources to provide quality, value-based care close to home.
Our clinical and business support capabilities, expertise and industry-leading technologies keep local practices at the forefront of high quality, efficient care delivery while enabling practice success, quality of life and financial security for physicians.
- 25 years of oncology practice management expertise
- Leader in value-based cancer care with over 900 physicians participating in the Center for Medicaid and Medicare
- Innovation Oncology Care Model – one fourth of the entire population of physicians nationwide
- Over 1,400 affiliated physicians
- More than 450 cancer treatment center locations across the United States
- Over 995,000 patients treated annually