Fda Inspector Jobs in Tennessee (NOW HIRING)

It's More Than a Career, It's a Mission.
Our people are the foundation of our success. By joining our growing team at Sarah Cannon Research Institute (SCRI), a subsidiary of McKesson, you will have the opportunity to become part of one of the largest community-based cancer programs to advance oncology treatments and improve outcomes for cancer patients across the globe. We look for mission-driven candidates who have a desire to advance the fight against cancer and make a difference in the lives of patients diagnosed with cancer every day.
Our Mission
People who live with cancer - those who work to prevent it, fight it, and survive it - are at the heart of every decision we make. Bringing the most innovative medical minds together with the most passionate caregivers in their communities, we are transforming care and personalizing treatment. Through clinical excellence and cutting-edge research, SCRI is redefining cancer care around the world.
As the Study Coordinator you will plan the execution and monitor the completion of complex Phase I-IV assigned clinical research protocols. Including abstracting, assembling and organizing research data while monitoring adherence to the clinical protocol and preparing reports on the data. Will work closely with the physician principal investigator, manager of data operations, clinical trial sponsor and study team.

• You will lead the execution of trials for the research team

• You will plan and track all assigned clinical activity in the lifecycle phases of the startup, interim and close out

• You will confirm patient eligibility and discuss discrepancies with nursing staff and physicians

• You will verify study procedures are performed within the protocol specified window

• You will participate in teleconferences with sponsors to update on patients including research visits, toxicity, and overall response. Responsible for sending notification out to department before and after calls to update study staff

• You will present in weekly protocol meeting to investigators, research staff, and management

• You will provide pertinent safety information to sponsor and study teams by monitoring patient toxicity, including serious adverse events, on trial according to Common Toxicity Criteria

• You will update internal research teams on protocol modifications and specifications including visit schedule, assessment windows, dose modifications, central and local laboratory assessments

• You will create study specific tools for source documentation including eligibility worksheets, screening checklists and worksheets capturing vital signs, blood sampling (as applicable)

• You will ensure study specific tools, including source documents (including paper and/or EMR), are updated with any amendment(s) or study changes

• You will investigate root cause of major protocol deviations and manages the follows up with responsible departments for corrective and preventative actions

• You will ensure pharmacy has Investigative Product and supplies

• You will interface with laboratory technician for lab kits and processing

• You will track and report adverse events, serious adverse events, protocol waivers, deviations and violations

• You will participate in monitor visits for each assigned trial at each monitoring visit

• You will review and comment on monitor letters within 5 business days of receipt and insures resolution of open items

• You will review source documentation and queries for missing documentation

• You will collect, complete and enter data into study-specific case report forms or electronic data capture systems within the contractually agreed upon timeframe

• You will maintain case report forms tracking management database

• You will review trial data for clinical relevance and answers appropriate queries Apprises research scientists and management team of all study specific medical issues for guidance

• You will assist in ensuring physician oversight by updating on protocol issues and obtaining signatures and clinical significance of laboratory reports, ECGs, and adverse events

• You will assist in external sponsor audit and US FDA inspection preparation, conduct, and close out processioning

• You will review and responds to audit findings and escalates issues

• You will maintain and archive study documentation and correspondence per company policy

• You will reports patient visit and data entry information in financial tracking system.

• You will provide required metrics to leadership

• You will initiate improvements to enhance the efficiency and the quality of the work performed on assigned projects

• You will adhere to professional standards and SOP's established for clinical research

• You will assist internal quality team in preparation for sponsor and US FDA audit teams

You should have for this role:

• An understanding of clinical trial data.

• Knowledge of FDA guidelines and GCP is required.

• The ability to work independently in a fast paced environment.

• Interpersonal skills, detailed-oriented and meticulous.

• Computer skills with ability using clinical trial databases, electronic data capture, MS Access or Excel

• Bachelor Degree is preferred

• At least one year of experience in healthcare, research or other science related field

• At least one year of experience planning and managing clinical trial process

About Sarah Cannon Research Institute
Sarah Cannon Research Institute (SCRI) is one of the world's leading oncology research organizations conducting community-based clinical trials. Focused on advancing therapies for patients over the last three decades, SCRI is a leader in drug development. In 2022, SCRI formed a joint venture with former US Oncology Research to expand clinical trial access across the country. It has conducted more than 850 first-in-human clinical trials since its inception and contributed to pivotal research that has led to the majority of new cancer therapies approved by the FDA in the past decade. SCRI's research network brings together more than 1,300 physicians who are enrolling patients into clinical trials at more than 200 locations in 20+ states across the U.S. Please click here to learn more about our research offerings.
We care about the well-being of the patients and communities we serve, and that starts with caring for our people. That's why we have a Total Rewards package that includes comprehensive benefits to support physical, mental, and financial well-being. Our Total Rewards offerings serve the different needs of our diverse colleague population and ensure they are the healthiest versions of themselves. For more information regarding benefits through our parent company, McKesson, please click here.
As part of Total Rewards, we are proud to offer a competitive compensation package. This is determined by several factors, including performance, experience and skills, equity, regular job market evaluations, and geographical markets. In addition to base pay, other compensation, such as an annual bonus or long-term incentive opportunities may be offered.
McKesson has become aware of online recruiting-related scams in which individuals who are not affiliated with or authorized by McKesson are using McKesson's (or affiliated entities, like CoverMyMeds or RxCrossroads) name in fraudulent emails, job postings or social media messages. In light of these scams, please bear the following in mind:
McKesson Talent Advisors will never solicit money or credit card information in connection with a McKesson job application.
McKesson Talent Advisors do not communicate with candidates via online chatrooms or using email accounts such as Gmail or Hotmail. Note that McKesson does rely on a virtual assistant (Gia) for certain recruiting-related communications with candidates.
McKesson job postings are posted on our career site: careers.mckesson.com.
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.