Manager of Regulatory Sites at Sarah Cannon Network in Nashville, Tennessee

Job Description:

DESCRIPTION SHIFT: No Weekends

SCHEDULE: Full-time

SARAH CANNON is the research arm of HCA's global cancer enterprise. Focused on advancing therapies for patients, it is one of the world's leading clinical research organizations conducting community-based clinical trials in oncology, cardiology and orthopedics through affiliations with a network of more than 1,000 physicians across the United States and United Kingdom.

We believe our success is dependent on a healthy work environment where staff members are the core of advancing therapies for patients and accelerating drug development. We apply the same compassion and commitment we have for our patients to our co-workers and colleagues and promote an entrepreneurial culture.

BENEFITS:

* Tuition Reimbursement/Assistance Programs

* Paid Personal Leave

* 401k (100% annual match - 3%-9% of pay based on years of service)

* Identity Theft Protection discounts

* Auto, Home, and Life Insurance options

* Adoption Assistance

* Employee Stock Purchase Program (ESPP)

As the MANAGER OF REGULATORY SITES, your primarily responsibilities include oversight for Tennessee Oncology's site level regulatory documentation for multiple clinical trials per FDA and GCP guidelines and includes oversight of a team of colleagues. You will establish, enforce and execute policies that ensure regulatory documentation -both electronic and paper binders - are compliant with all applicable laws, regulations, SOPs, and other applicable guidelines. You will also work closely with the regulatory affairs department, site leadership and/or principal investigators to ensure compliance.

* You will manage performance and professional development of Site Support staff, developing status reports based on department metrics and communicate to leadership.

* You will provide site level regulatory support to the TN Oncology site and internal department leaders in relation to the status of start-up and ongoing regulatory maintenance

* You will work closely with department directors and/or principal investigators to optimize processes to ensure both efficiency and quality

* You will establish and maintain a document management system for regulatory paper and electronic files for each study at the site

* You will maintain updated physician credentials for TN Oncology site and other critical documentation ensuring compliance

* You will maintain study specific DOA log

* You will resolve key monitor issues with Pharmaceutical Industry Partners and Government Agencies

* You will provide response to regulatory items on monitor follow up letter

* Tracks documents pending site regulatory signatures

* You will maintain FDA and GCP required regulatory documentation for individual sites, studies, sponsors and/or other networks.

* You will establish, enforce and execute policies that ensure site level documentation and binders are compliant with all applicable laws, regulations, SOPs and other applicable guidelines.

* You will triages site requests for regulatory support and identifies correct pathway for issue resolution

QUALIFICATIONS YOU SHOULD HAVE FOR THIS POSITION:

* An Associate's Degree

* Clinical and/or Regulatory experience in a research setting required

* Customer focused experience required

IT IS PREFERRED THAT YOU HAVE:

* Bachelor's Degree (4 year program)

* Management experience

DO YOU WANT TO WORK ON A TEAM FIGHTING CANCER TOGETHER? APPLY NOW TO LEARN MORE ABOUT THIS OPPORTUNITY.

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.

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