Regulatory Affairs Coordinator
About the job
- An Associate Degree is required; a Bachelor’s Degree is preferred.
- Process regulatory document signature requests through an electronic signature platform.
- Track documents pending site regulatory signatures.
- Provide site-level regulatory support to Clinical Operations sites and internal department managers regarding start-up and ongoing regulatory maintenance status.
- Establish and maintain a document management system for regulatory paper and electronic files.
- Maintain Food and Drug Administration (FDA) and Good Clinical Practice (GCP) required regulatory documentation for individual sites, studies, sponsors, and networks, ensuring it complies with local Standard Operating Procedures (SOPs) for format and content.
- Maintain updated physician credentials for network participants and other critical documentation to ensure compliance.
- Triage site requests for regulatory support and identify the correct pathway for issue resolution.
- Regulatory experience is preferred.
- Customer service experience is preferred.
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 Regulatory Coordinator you are responsible for managing and planning regulatory affairs compliance for industry sponsors and/or sites in networks. In this position you will work closely with the regulatory affairs management, department director and/or primary investigators to ensure compliance, preparing for auditing activities while meeting strict deadlines.
- You will process regulatory document signature request through an electronic signature platform
- You will track documents pending site regulatory signatures
- You will provide site level regulatory support to the Clinical Operations’ sites and internal department managers in relation to the status of start-up and ongoing regulatory maintenance
- You will establish and maintain a document management system for regulatory paper and electronic files
- You will maintain Food and Drug Administration (FDA) and Good Clinical Practice (GCP) required regulatory documentation for individual sites, studies, sponsors and/or other networks. You will ensure all regulatory documentation is compliant with local Standard Operating Procedures (SOP’s) for format and content
- You will maintain updated physician credentials for network participants and other critical documentation ensuring compliance
- You will triage site requests for regulatory support and identifies correct pathway for issue resolution
You should have for this position:
- An Associate Degree, preferably a Bachelor’s Degree
- Regulatory experience is preferred
- Customer service experience is 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. 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.
About the company
Sarah Cannon Research Institute (SCRI) is a global oncology research organization that conducts cancer clinical trials in community settings, partnering with pharmaceutical and biotech sponsors, physicians, and patients to develop new treatments. It works as an oncology-focused contract research organization (CRO) and centralized site management organization (SMO), running trials across more than 200 locations with roughly 1,500 research physicians, and applies technology such as its Accelero platform to personalized-medicine studies. Over more than 30 years it has completed more than 900 first-in-human trials across early- to late-phase research. What sets SCRI apart is this community-based model paired with early-phase depth, which has helped advance most new cancer therapies the FDA approved in the past decade. The goal is to accelerate oncology research from early trials to approval and bring advanced cancer treatments to patients.
Company Size
1-10
Company Stage
N/A
Total Funding
N/A
Headquarters
Beach Haven, New Jersey
Founded
N/A
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Simplify's Take
What believers are saying
- Pfizer expanded its May 20, 2026 collaboration after three Accelero studies became ten.
- Merck signed August 13, 2026 access expansion using SCRI's community trial network.
- August 24, 2026, Mary Crowley added Dr. Cheedella to expand North Texas early-phase access.
What critics are saying
- SCRI depends on Pfizer, Merck, and Bristol Myers Squibb concentration across oncology pipelines.
- HCA's control exposes SCRI to parent capital allocation and hospital-system priority shifts.
- A major GCP or data-integrity failure would freeze sponsors and threaten SCRI's network.
What makes Sarah Cannon Research Institute unique
- SCRI's Accelero cut study activation 47% and first-patient enrollment 57% faster in 2026.
- In May 2026, SCRI presented 155+ ASCO abstracts, signaling deep investigator output.
- SCRI runs 200+ community sites with about 1,500 oncology physicians across 20+ states.
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Benefits
- Flexible Work Hours
Company News
Sarah Cannon Research Institute showcases 85+ oncology research presentations at ESMO 2026, highlighting advances across multiple tumor types. October 20, 2026 | Research presented includes work from 40 authors across the Sarah Cannon Research Institute network of research sites NASHVILLE, Tenn.-(BUSINESS WIRE)-Sarah Cannon Research Institute (SCRI), one of the world's leading oncology research organizations conducting community-based clinical trials, will highlight its latest research insights through more than 85 abstracts and presentations at the annual European Society for Medical Oncology (ESMO) conference in Madrid, Spain, from October 23-27. Each year, ESMO brings together thousands of leading researchers, physicians and oncology professionals from around the world to share the latest advances shaping the future of cancer care. SCRI thought leaders are presenting recent findings from several early- and late-phase clinical trials focused on a variety of targeted treatment approaches like antibody drug conjugates (ADCs), immunotherapies and bispecifics. "Each abstract presented by SCRI investigators at ESMO represents our mission to bring cutting-edge cancer research closer to patients," said David R. Spigel, MD, President and Chief Medical Officer, SCRI. "Our investigators are helping answer critical questions across a wide range of tumor types and treatment approaches, all with the goal of accelerating progress for patients. We're honored to share these findings and contribute to conversations that will help define the next generation of cancer care." Notable presentations include: Benjamin Garmezy, MD, SCRI, will present "Safety and efficacy of JNJ-6143, a first-in-class oral AR-targeted RIPTAC(TM) at the optimal dose for further development in patients with mCRPC/mAPMR, including high-risk molecular features" in an oral presentation on October 24, 2026, from 10:35 a.m. to 10:45 a.m., during a session in the Barcelona Auditorium (Hall 9). Meredith McKean, MD, MPH, SCRI, will present "Patritumab Deruxtecan (HER3-DXd) in Melanoma After Anti-PD-(L)1 Therapy: Primary Analysis From HERTHENA-PanTumor01" in an oral presentation on October 25, 2026, from 10:20 a.m. to 10:25 a.m., during a session in the Bilbao Auditorium (Hall 3). October 25 at 4:30 p.m., "Krascendo 1: efficacy and safety of divarasib (diva) vs sotorasib (soto) or adagrasib (ada) in previously treated locally advanced or metastatic KRAS G12C-mutated NSCLC" will be presented in Hall 6 of the Alicante Auditorium. This research was co-authored by Bo Wang, MD, SCRI at Willamette Valley Cancer Institute and Research Center | The US Oncology Network. Dax Kurbegov, MD, Sarah Cannon Cancer Network, will present "Efficiency and Safety of Cancer Signal Origin (CSO)-Guided Diagnostic Workups Following Multi-Cancer Early Detection (MCED) Testing: Results from PATHFINDER 2 (PF2)" in an oral presentation on October 26, 2026, from 3:22 p.m. to 3:27 p.m., during a session in the Salamanca Auditorium (Hall 10). Erika Hamilton, MD, SCRI, will deliver a presentation on Next Generation Therapies during the Novel Concepts for Metastatic Breast Cancer session on October 24 at 4:45 p.m. in Hall 9 of the Barcelona Auditorium. October 25, Melissa Johnson, MD, SCRI, will also take part in a panel discussion on non-small cell lung cancer at 10:15 a.m. in Hall 6 of the Alicante Auditorium. Additional SCRI First-Author Poster Presentations Breast Cancer * Dr. Erika Hamilton will present "Efficacy, safety, and biomarker analysis of DB-1310 (HER3-targeted ADC) in pretreated HR+/HER2- breast cancer: Updated global phase 1/2a trial" on October 24, 2026, from 12:00 p.m. to 12:45 p.m. * Nina Balanchivadze, MD, SCRI at Virginia Oncology Associates | The US Oncology Network, will present "Real world (RW) outcomes in HR+/HER2- metastatic breast cancer (mBC) patients, by second-line (2L) treatment" on October 24, 2026. * Judy S. Wang, MD, SCRI at Florida Cancer Specialists & Research Institute | The US Oncology Network will present "First-in-class Rac/Cdc42 inhibitor MBQ-167 in patients with metastatic breast cancer (MBC): safety and preliminary efficacy" on October 24, 2026, from 12:00 p.m. to 12:45 p.m. Genitourinary Cancer * Dr. Benjamin Garmezy will present "A phase 3, randomized, open-label trial comparing elfetabart drozuntecan, a B7H3 antibody-drug conjugate (ADC), with docetaxel as treatment of patients with taxane-naïve metastatic castration-resistant prostate cancer (mCRPC)" on October 23, 2026, from 3:15 p.m. to 4:00 p.m. in Hall 5. Gynecologic Cancer * Noelle Cloven, MD, SCRI at Texas Oncology | The US Oncology Network will present "Defining the Molecular Landscape of HRD Negative Ovarian Cancer: A Real World Data Set to Enable Synthetic Control Arm Generation" on October 25, 2026 from 12:00 p.m. to 12:45 p.m. Head & Neck Cancer * Cesar Perez, MD, SCRI at Florida Cancer Specialists & Research Institute | The US Oncology Network will present "A first-in-human phase 1/2 dose-escalation and expansion trial of BNT329 (an anti-carbohydrate antigen 19-9 antibody-drug conjugate [CA19-9 ADC]) in patients with advanced solid tumors that express CA19-9" on October 24, 2026, from 3:15 p.m. to 4:00 p.m. Lung Cancer * David Spigel, MD, SCRI, will present "Deep-Learning Serial CT Imaging Predictions of Survival Compared with RECIST 1.1 Objective Response Rate in Immunotherapy-Treated NSCLC." * Dr. Melissa Johnson will present "First-line (1L) Olomorasib + Pembrolizumab in KRAS G12C-Mutant NSCLC: Updated Results from LOXO-RAS-20001 and SUNRAY-01" on October 26, 2026, from 12:00 p.m. to 12:45 p.m. * Dr. Bo Wang will present "TeLuRide-005: Phase 2 study of EIK1001 (TLR7/8 dual agonist) plus pembrolizumab and chemotherapy in patients with stage IV NSCLC: results from the squamous cohort and updated pooled results" on October 26, 2026, from 12:00 p.m. to 12:45 p.m. * Elisa Fontana, MD, SCRI at HCA Healthcare UK, will present "Prospective validation of artificial intelligence (AI)-assisted RECIST 1.1 in a phase 1 study of fetrastobart vedotin in patients with non-small cell lung cancer (NSCLC)" on October 25, 2026, from 12:00 p.m. to 12:45 p.m. Skin Cancer * Dr. Meredith McKean will present "Darovasertib and Crizotinib for HLA-A02-Positive Metastatic Uveal Melanoma: Results from the Phase 2 OptimUM-01 Study" on October 24, 2026, from 12:00 p.m. to 12:45 p.m. Additional Presentations * Dr. Melissa Johnson will present "Preliminary safety and pharmacokinetics of TJ101, an EGFR x B7-H3 bispecific antibody-drug conjugate, in patients with advanced solid tumors: results from an ongoing global Phase I study" on October 23, 2026, from 3:15 p.m. to 4:00 p.m. * Gerald Falchook, MD, SCRI at HCA HealthONE, will present "AXL inhibitor AB801 in patients with advanced malignancy: Dose escalation results from the phase 1/1b ARC-27 study" on October 23, 2026, from 3:15 p.m. to 4:00 p.m. Additionally, Dr. Falchook will present "Dose optimization of ragistomig (ABL503/TJ-L14B), a PD-L1 x 4-1BB Bispecific Antibody" on October 23, 2026, from 3:15 p.m. to 4:00 p.m. and "Phase 1 study of BHV-1530, a first-in-class FGFR3 ADC in Advanced Tumors" on October 23, 2026, from 3:15 p.m. to 4:00 p.m. About Sarah Cannon Research Institute (SCRI) 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. It has conducted more than 1,000 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 approximately 1,500 oncology physicians who provide access to clinical trials in SCRI's research network of over 200 locations in more than 20 states across the U.S. Visit SCRI.com to learn more.
Recent news & announcements. August 24, 2026 Sarah Cannon Research Institute Appoints Naga Koteswari Sucharita Cheedella, MD, as Associate Director of SCRI at Mary Crowley, Its Dallas-Based Early-Phase Drug Development Unit Experienced early-phase investigator will help advance drug development and clinical trial access for patients in North Texas Sarah Cannon Research Institute (SCRI), one of the world's leading oncology research organizations conducting community-based clinical trials, is pleased to announce the appointment of Naga Koteswari Sucharita "Suchi" Cheedella, MD, as Associate Director of SCRI at Mary Crowley, effective September 1, 2026. An experienced early-phase investigator and gastrointestinal oncologist, Dr. Cheedella will help advance the development of novel cancer therapies and expand access to clinical trials for patients across North Texas. Dr. Cheedella will be employed by Texas Oncology, part of the SCRI research network, and dedicated solely to SCRI at Mary Crowley. SCRI at Mary Crowley is one of SCRI's seven early-phase drug development units and serves as a hub for advancing cutting-edge cancer therapies in North Texas. "Dr. Cheedella brings deep experience in early drug development, gastrointestinal oncology and community-based clinical research," said David Spigel, MD, President and Chief Medical Officer, SCRI. "Her scientific leadership, clinical experience and commitment to patients will be invaluable in advancing innovative therapies and broadening access to research opportunities." She is a triple board-certified physician in internal medicine, hematology, and medical oncology. She joins SCRI at Mary Crowley from Texas Tech University Health Sciences Center in Lubbock, where she served as an associate professor, director of the Early Drug Development Program, and co-director of the Gastrointestinal Oncology Program. Previously, she also served as a Phase 1 clinical investigator at NEXT Oncology Dallas and held faculty appointments at UT Health San Antonio, Texas Tech University Health Sciences Center, and UT Southwestern Medical Center. Her clinical research experience spans first-in-human and other early-phase studies, including targeted therapies, immunotherapies, antibody-drug conjugates, and RAS inhibitors. She has served as a principal investigator and sub-investigator on clinical trials and has authored or co-authored research published and presented in leading oncology forums. Dr. Cheedella completed her hematology and oncology fellowship and internal medicine residency at Brookdale Hospital Medical Center in Brooklyn, New York, serving as chief fellow during her final year of fellowship. She earned her medical degree from Osmania Medical College in Hyderabad, India. SCRI at Mary Crowley joined the SCRI research network in 2025, building on more than 25 years of early-phase research in Dallas and a longstanding collaboration with Texas Oncology physicians. The center has conducted more than 850 clinical trials and continues to offer patients access to innovative treatment options close to home.
SCRI and MSD to broaden US oncology trial access. Salong Debbarma Updated Fri, August 14, 2026 at 2:46 AM PDT Sarah Cannon Research Institute (SCRI) and Merck & Co (MSD) have entered a collaboration aimed at increasing patient access to oncology clinical trials at community sites across the US. The partnership will utilise SCRI's Accelero delivery model, which is designed to improve both the reach and efficiency of cancer studies. MSD and SCRI are seeking to address the increasing complexity of oncology clinical studies, which require more precise patient selection and faster access to new therapies. The organisations aim to implement new approaches for trial delivery that are efficient, use advanced data methods, and can be integrated within local communities. MSD Research Laboratories associate vice-president and North America global clinical trial operations head Jennifer Coppola said: "At MSD, we are focused on advancing research to better understand cancer and potential therapeutic approaches. "By leveraging the Accelero delivery model, we have the potential to reach patients faster, reduce protocol complexity, and make oncology clinical studies more accessible in the communities where patients live." The Accelero model employed by SCRI includes accelerated trial site start-up, electronic data transfer systems connecting electronic health records (EHR) and case report forms, and initiatives to boost recruitment. Collaborations using Accelero have reported trial site activations up to 50% faster than conventional approaches, with enrolment rates 19% higher than the national average of 7%, and 95% fewer changes to data compared to standard processes. SCRI runs a network comprising around 1,500 oncology physicians, offering access to clinical studies at over 200 sites in more than 20 US states. The group reports involvement in over 900 first-in-human clinical trials since its formation. In October 2024, Exelixis and MSD partnered to assess the potential of combining their respective cancer therapies in upcoming trials. "SCRI and MSD to broaden US oncology trial access" was originally created and published by Clinical Trials Arena, a GlobalData owned brand.
Sarah Cannon Research Institute (SCRI) has announced a strategic collaboration with Pfizer to accelerate oncology drug development through SCRI's Accelero clinical trial delivery model. The partnership aims to streamline trial operations and expand patient access to innovative cancer therapies in community settings. SCRI and Pfizer previously collaborated on three studies using Accelero, which quickly expanded to over ten trials. The model has achieved a 47% reduction in study activation timelines and enrolled first patients 57% faster compared to historical performance. SCRI physicians will provide strategic guidance across Pfizer's oncology portfolio using real-world data to inform study design and clinical strategy. The collaboration leverages SCRI's network of approximately 1,500 oncology physicians across over 200 locations in more than 20 US states.
Why research matters at Colorado Blood Cancer Institute. At Colorado Blood Cancer Institute, research is more than discovery. It is part of how care moves forward. Through its collaboration with Sarah Cannon Research Institute, CBCI is helping connect patients to emerging therapies, advance early-phase blood cancer research and contribute to national conversations shaping the future of oncology care. May 14, 2026 At Colorado Blood Cancer Institute (CBCI), research is woven into patient care. It shapes how care is delivered, opens doors to new possibilities and helps move progress forward for every patient who walks through its doors. That matters deeply in blood cancer care, where treatment is evolving at a remarkable pace. New therapies, new combinations and new approaches are steadily expanding what may be possible for patients. In that environment, research is not only about discovery. It is also about access, helping connect patients to emerging options while shaping the future of cancer care. At Colorado Blood Cancer Institute, that work is supported through an embedded research infrastructure in collaboration with Sarah Cannon Research Institute (SCRI). Kelly Mozzetta, regional director of oncology research operations for CBCI and Sarah Cannon Research Institute at HCA HealthONE, a phase I drug development unit, describes a model in which regulatory specialists, coordinators, nurses, lab teams and physicians work closely together to bring clinical trials to patients in the Rocky Mountain region. Rather than operating separately, the research team is integrated into the day-to-day life of the organization and works together to support patients throughout their care journey. That level of integration matters for patients. Clinical trials can offer access to therapies that may not otherwise be available, particularly for patients whose disease has relapsed or who have exhausted standard FDA-approved treatment options. Just as important is the level of physician engagement. Mozzetta emphasizes that research involvement at Colorado Blood Cancer Institute is not limited to a small subset of providers. Instead, she describes strong engagement across the physician group, along with active work in complex and emerging areas such as early-phase blood cancer research and cellular therapy. Joshua Gordon, manager of study operations at Sarah Cannon Research Institute at HCA HealthONE, adds that Colorado Blood Cancer Institute is a leader in early-phase blood cancer research and consistently ranks among the highest-enrolling practices within the field. The recent selection of an abstract by Dr. Peter Forsberg for presentation at the 2026 American Society of Clinical Oncology (ASCO), Annual Meeting, the largest oncology conference in the world, offers one example of that culture in action. ASCO is one of the most prominent conferences in cancer care, making abstract selection a meaningful marker of scientific contribution and national visibility. More broadly, it reflects the caliber of work taking place at Colorado Blood Cancer Institute and its role in larger conversations shaping oncology care. The larger takeaway is clear: research is how cancer care advances. At Colorado Blood Cancer Institute in collaboration with Sarah Cannon Research Institute, that work is carried forward through scientific rigor, physician engagement and a shared commitment to expanding what is possible for patients. Published: May 13, 2026 May 11, 2026 Pap smear results can be confusing or scary. Learn what normal and abnormal results mean, what affects cervical cancer risk, and when follow-up testing is needed. March 03, 2026 | Amy J. Ware, MHA, MEd, FACHE January 27, 2026 Lifestyle tips and changes people can take to improve their cervical health.