Drug Safety Coordinator - Nashville, TN

JSC SCRI Holdings LLC; Tennessee; Híbrido; USD 65.000 - 90.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Total Rewards package

Hybrid work arrangement

Descripción de la vacante

Sarah Cannon Research Institute (SCRI), a McKesson subsidiary, seeks a Safety Coordinator to protect patient safety in clinical trials. The role blends on-site work in Nashville, TN with flexible hybrid arrangements and rigorous pharmacovigilance practices.

You will implement safety monitoring plans, review AE/SAE reports, and prepare regulatory submissions while adhering to GCP and ICH guidelines. A strong clinical research background and EMR/database experience are required.

Formación

• Bachelor's degree preferred; work experience may substitute.
• 3+ years in clinical research or life sciences with regulatory language.
• Experience with EMR systems and safety databases (ARGUS, Aris-G, Veeva).
• MedDRA experience preferred.

Responsabilidades

• Develop and maintain a Safety Monitoring Plan for trials.
• Review adverse event and SAE reports.
• Enter safety data in ARGUS database.
• Write clinical narratives of safety events.
• Determine reporting requirements to regulators.
• Collaborate with monitors, sponsors, and regulators.
• Ensure GCP, ICH, and SOP compliance.

Conocimientos

Clinical research terminology

Regulatory terminology

Microsoft Office

Educación

Bachelor's degree

Herramientas

ARGUS

Aris-G

Veeva

MedDRA

Descripción del empleo

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.

Our Safety Coordinator is responsible for monitoring, documenting, evaluating, and reporting the safety of patients participating in clinical research studies. They serve as the primary pharmacovigilance (drug safety) contact between research sites, study teams, sponsors, and regulatory authorities. This role is critical because it directly protects the safety and well‑being of patients participating in clinical trials. This is a hybrid position working 2 days onsite at our corporate offices in Nashville, TN; relocation assistance and visa work sponsorship are not available.

Key responsibilities

• Developing and maintaining a Safety Monitoring Plan (SMP) that outlines how safety events will be identified, reviewed, and reported throughout a clinical trial.
• Reviewing and processing adverse event (AE) and serious adverse event (SAE) reports.
• Entering and maintaining safety cases in the ARGUS safety database.
• Writing clear clinical narratives that explain patient safety events.
• Determining whether safety events are expected or unexpected and whether they require regulatory reporting.
• Coding medical information using industry‑standard dictionaries such as MedDRA and WHO Drug.
• Preparing and submitting expedited safety reports to regulatory agencies (such as the FDA) and Institutional Review Boards (IRBs)/Ethics Committees.
• Performing ongoing reviews of cumulative safety data to identify trends or emerging risks.
• Collaborating with medical monitors, study chairs, sponsors, and regulatory teams to evaluate patient safety.
• Ensuring all safety activities comply with Good Clinical Practice (GCP), ICH guidelines, regulatory requirements, and company SOPs.

Qualifications for success

• Bachelor's Degree highly preferred - work experience may be substituted for education.
• 3+ years' professional experience in clinical research, pharmaceutical or life sciences environment utilizing scientific, medical, and regulatory terminology.
• Technology skills will include multiple EMR systems, MS Windows and Office including Excel, Power Point, Outlook, as well as Safety Dabase experience such as ARGUS, Aris‑G, Veeva Medical data entry experience required - laboratory, clinical, medical systems
• MedDRA experience strongly preferred.

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.

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. 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.

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.

About McKesson

We deliver careers with purpose and potential. Our focus on better health starts with creating an inclusive environment with strong values where you can build a fulfilling career. You can count on us to provide you with resources and opportunities to grow and be your best, while contributing to our pursuit of improving lives.

Every day, McKesson’s employees deliver products to healthcare providers that make a difference in the care and life of a patient.

We work to distribute medical supplies, bandages, syringes, vials of flu vaccine, and pharmaceutical drugs to help real patients like Jack, an eight‑year‑old boy battling cancer. We take that job seriously. Together, the work we do is shaping the future of healthcare.

Every day, McKesson’s employees deliver products to healthcare providers that make a difference in the care and life of a patient.

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.