Job description
Overview:
Facing cancer takes great strength and courage. It also takes an exceptional Senior Regulatory Affairs Coordinator working alongside clinical and administrative staff and being a part of our patient's experience in our clinics.
If you like managing all regulatory processes and procedures for clinical trials and have the skills and passion to lead a team, we want you to join our team.
About Us:
Our mission is to increase access to and advance the delivery of high-quality cancer care in America. As part of US Oncology, one of the nation's largest healthcare services networks dedicated exclusively to cancer treatment and research, we can quickly bring the latest advances in cancer care to our patients. Most importantly, we understand the special needs of cancer patients, and are devoted to caring for the whole person, not just the disease. Our physicians and staff treat patients in over 17 locations throughout the state including Goodyear, Green Valley, Phoenix, Prescott Valley, Scottsdale, and Tucson.
Benefits:
We offer competitive pay and a comprehensive benefit package that includes, 401K Profit Sharing Plan, Critical Care Insurance, Dental Insurance, Health Spending Account, Legal Insurance, Long-Term Care, Medical Insurance, Paid Time Off Plan, Short and Long-Term Disability, Tuition Reimbursement, Vision Insurance.
To make a difference in someone's life, you don't have to be brilliant, rich, beautiful or perfect. You just have to care.
Responsibilities:
In your job, you will have the ability to make a difference in a patient's journey by:
Minimum Qualifications:
What You Bring to the Team:
The safety of our patients and staff is our top priority. Masks may be required in all Arizona Oncology facilities regardless of vaccination status. Candidates who accept employment including current employees who are applying for internal positions, are required to provide proof of Covid-19 vaccination prior to their start date. Religious and medical exemptions are available to those who meet the criteria.
Facing cancer takes great strength and courage. It also takes an exceptional Senior Regulatory Affairs Coordinator working alongside clinical and administrative staff and being a part of our patient's experience in our clinics.
If you like managing all regulatory processes and procedures for clinical trials and have the skills and passion to lead a team, we want you to join our team.
About Us:
Our mission is to increase access to and advance the delivery of high-quality cancer care in America. As part of US Oncology, one of the nation's largest healthcare services networks dedicated exclusively to cancer treatment and research, we can quickly bring the latest advances in cancer care to our patients. Most importantly, we understand the special needs of cancer patients, and are devoted to caring for the whole person, not just the disease. Our physicians and staff treat patients in over 17 locations throughout the state including Goodyear, Green Valley, Phoenix, Prescott Valley, Scottsdale, and Tucson.
Benefits:
We offer competitive pay and a comprehensive benefit package that includes, 401K Profit Sharing Plan, Critical Care Insurance, Dental Insurance, Health Spending Account, Legal Insurance, Long-Term Care, Medical Insurance, Paid Time Off Plan, Short and Long-Term Disability, Tuition Reimbursement, Vision Insurance.
To make a difference in someone's life, you don't have to be brilliant, rich, beautiful or perfect. You just have to care.
Responsibilities:
In your job, you will have the ability to make a difference in a patient's journey by:
- Coordinate Critical Document Collection to facilitate the timely opening of trials at the site; communicate and collaborate with central operations and data management to identify and resolve any regulatory issues.
- Maintains Protocol Regulatory Documents in compliance with local and US Oncology Standard Operating Procedures; assist with local QA Initiatives; lead development and implementation of quality improvement measures to assist Investigators with protocols and regulations.
- As subject matter expert develops and implements training materials to ensure the staff are in compliance and up to date on all Federal, State, and local laws and regulations.
- Oversee the preparation of Informed Consent Documents regulatory packets (FDA1572, FDQ) for sponsor and IRB submissions; review local and central Institutional Review Board submissions; monitor and report SAEs to sponsor/FDA/IRB.
- Facilitate collection of site training documents from study initiation visits as well as coordinate and collect ongoing amendment training documents; actively participate in study initiations and study specific educational programs.
- Compile information necessary for continuing review by local IRB or for Network Principal Investigator annual continuing review for USOR trials.
- Train and mentor research staff on all regulatory aspects of clinical research.
Minimum Qualifications:
- Associate degree required.
- Minimum seven years of experience in clinical research, regulatory affairs and/or an oncology related field required.
What You Bring to the Team:
- Associate's or Bachelor's degree in a clinical or scientific related discipline preferred.
- Experience with Microsoft Office.
- Experience working with Sponsor Monitor representatives.
- Prior supervisory experience strongly preferred.
- Excellent time management skills.
- Strong interpersonal skills and able to interact with multiple people on many different levels.
The safety of our patients and staff is our top priority. Masks may be required in all Arizona Oncology facilities regardless of vaccination status. Candidates who accept employment including current employees who are applying for internal positions, are required to provide proof of Covid-19 vaccination prior to their start date. Religious and medical exemptions are available to those who meet the criteria.
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