Research Regulatory Specialist

Ironwood Cancer & Research Centers

Ironwood Cancer & Research Centers has beautiful state-of-the-art integrated Cancer and Women's Centers, with locations strategically located throughout the Valley. Each one provides a superior cancer care environment with a full spectrum of cancer related services for patients. Our multi-disciplinary team approach includes surgical oncology, medical oncology, radiation oncology, women's centers, diagnostic imaging services, social service support, nutritionist, integrative services, and genetic counseling.

Mission Statement: To serve the community by providing quality, comprehensive cancer care which respects the values and needs of each individual.

Position Summary:

Responsible for ensuring timely submission of complete, accurate, and neat documents to pharmaceutical sponsors, IRB, and contract research organizations, where applicable. Ensure compliance with training and maintenance of all documentation. Maintain and update site information as required.

Essential Duties and Responsibilities:

• Ensure ongoing maintenance of regulatory documents, IRB reporting and submissions of amendments, renewals, etc.
• Ensure delegation logs are complete.
• Assist with study start up activities such as site contact questionnaires, imaging questionnaires and qualifications, etc.
• Ensure consents and re-consents are done and documented properly in a timely manner.
• Ensure compliance with department standards and all federal regulations and international guidelines of good clinical practice.
• Facilitates and oversees study initiation visits, monitoring visits, closeout visits and audit visit, ensuring all study regulatory documentation and study issues are addressed.
• Assist with and ensure review of IND safety reports
• Manage, update and maintain all curriculum vitae and licenses for investigators and other study staff on delegation logs.
• Manage, update and maintain all local lab certifications and normal ranges.
• Ensure documentation of training is completed on training logs for all investigators, study staff and applicable clinical staff (pharmacy, nursing, etc.).
• Manage, update and maintain records of GCP/Human Subjects Protection, IATA, CPR and other training for investigators and study staff as appropriate.
• Communicates changes and distributes updated regulatory study information such as amendments and new consent forms.
• Will assist with drug receipt, storage and transport as needed for studies that require designated unblinded staff.

• Provides orientation, cross-training, and assistance for new/existing personnel.
• Must be able to type and work on a computer.
• Ability to work in a constant state of alertness and safe manner.
• Performs other duties as requested by supervisor, administrator, or physicians.

Minimum Qualifications

• Keen and acute attention to detail with excellent organization management skills.
• Proficiency in Microsoft Office, Word, Outlook, and Internet.
• Ability to use office equipment, computer.
• Strong written communication, verbal and interpersonal skills.
• Ability to be autonomous, exercise initiative and work effectively while managing a variety of study related projects simultaneously.
• Effective analytical skills for problem solving and making decisions.

Education and/or Experience:

• Associates Degree or two years of healthcare/research experience is required.
• Human Subject Protection Training to be completed and maintained

We offer a competitive salary and a comprehensive benefit package including health insurance, 401K and a caring work environment. We are an E.O.E.