Regulatory Affairs Administrator

Employer
US Oncology
Location
Fairfax, VA
Salary
Competitive
Posted
Jan 31, 2018
Closes
Feb 22, 2018
Specialty
Managerial
Contract Type
Permanent
Hours
Full Time
Are you looking for a career and not just a job in the Medical field?
Virginia Cancer Specialists, affiliated with McKesson Specialty Health and US Oncology, a leader in cancer care, is seeking an experienced full time
Regulatory Affairs Administrator.

Under minimal supervision, coordinates the research and administrative activities of clinical trials for the practice by managing Regulatory and Quality Assurance procedures. Responsible for regulatory and safety support services including trial communication and document distribution, critical document collection process, safety reporting, translation of informed consent documents and communication with sponsor representatives. Provides this support in compliance with the FDA Code of Federal Regulations (CFR), the ICH Good Clinical Practice (GCP) Guidelines, OHRP/DHHS guidelines. Supports and adheres to the US Oncology Compliance Program, to include the Code of Ethics and Business Standards.

ESSENTIAL DUTIES AND RESPONSIBILITIES :

-Coordinates local and central Institutional Review Board submissions as applicable. Oversees local quality assurance program and development of appropriate action plans. Collaborates with clinical staff to implement action plans to address identified quality improvement opportunities.

-Reports Serious Adverse Events (SAE) reports sponsor companies and/or FDA within regulation timelines. Communicates with physicians, research staff and sites and sponsors to resolve safety issues.

-Participates in and supports all site auditing and monitoring visits. Maintains protocol regulatory documents in compliance with local and US Oncology Research Standard Operating Procedure. Communicates, reviews, and documents Regulatory Memoranda with physicians and other clinical staff as appropriate.

-Assists in the development and implementation of policies and procedures for regulatory documentation functions.

-Actively participates in protocol initiations and study specific educational programs. Communicates and collaborates on an ongoing basis with central operations and data management.

-Flags patient medical record with protocol-specific communication and documentation to alert all staff regarding protocol requirements for each patient on a clinical trial. Acts as a resource for clinical staffs by reporting protocol activities at staff meetings.

-Presents, compiles and maintains documents needed for local Institutional Review Board (IRB) and Institutional Biosafety Committee (IBC) submissions.

-Maintains regulatory files by filing and auditing existing regulatory documentation prior to regularly scheduled monitoring visits and audits.

-Prepares regulatory documentation packets and creates all FDA 1572 forms for sponsor submission.

-Compiles information necessary for continuing review by local IRB and Institutional Biosafety Committee.

MINIMUM QUALIFICATIONS :

Bachelor's Degree in nursing or master's degree in health related field and minimal of five years experience in clinical research, regulatory affairs, and/ or an oncology related field. Minimum one year of oncology. Strong knowledge and use of computer databases. Computer proficiency in Microsoft Office including MS Word, Excel and PowerPoint. SOCRA or ACP preferred, Current BLCS or ACLS certification required.

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 sit and use hands to finger, handle, or feel. The employee is occasionally required to stand, walk, and reach with hands and arms. The employee must occasionally lift and/or move up to 30 pounds. Requires vision and hearing corrected to normal ranges.

WORK ENVIRONMENT :

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 physicians and clinical staff. Work will require occasional travel by air or automobile, approximately 20% of time.

Join us at Virginia Cancer Specialists, APPLY NOW!

The US Oncology Network is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, or national origin.

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Category: Administrative

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.

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