Regulatory Affairs Specialist Lead

7 days ago


The Woodlands, United States Lifelancer Full time
About the Role

We are seeking a highly skilled Regulatory Affairs Specialist I to join our team at Sarah Cannon Research Institute (SCRI), a subsidiary of McKesson. This is an excellent opportunity for a motivated and detail-oriented professional to contribute to the advancement of oncology treatments and improve outcomes for cancer patients globally.

The successful candidate will have a strong understanding of regulatory affairs compliance, including FDA and GCP guidelines, and experience in managing document management systems for regulatory paper and electronic files. Additionally, they will be responsible for maintaining updated physician credentials, informed consent forms, and protocol modifications in compliance with IRB policy and HIPAA.

Key Responsibilities
  • Manage and plan regulatory affairs compliance for industry sponsors and/or sites in networks.
  • Maintain Food and Drug Administration (FDA) and Good Clinical Practice (GCP) required regulatory documentation for individual sites, studies, sponsors, and/or other networks.
  • Establish and maintain a document management system for regulatory paper and electronic files.
  • Update and manage protocol and consent form modifications or amendments in compliance with Institutional Review Board (IRB) policy and HIPAA.
  • Organize and coordinate IRB documentation for trials.
About Us

Sarah Cannon Research Institute (SCRI) is one of the world's leading oncology research organizations, conducting community-based clinical trials. With over 30 years of experience, SCRI has contributed to pivotal research that has led to the majority of new cancer therapies approved by the FDA today.

As part of Total Rewards, we offer a competitive compensation package, including an estimated salary range of $65,000 - $85,000 per year, based on performance, experience, and skills. In addition to base pay, other compensation, such as an annual bonus or long-term incentive opportunities, may be offered.

What We Offer
  • A dynamic and supportive work environment.
  • Ongoing training and development opportunities.
  • A comprehensive benefits package, including medical, dental, and vision insurance.
  • A 401(k) retirement savings plan with employer match.
  • Tuition reimbursement and education assistance programs.


  • The Woodlands, United States Lifelancer Full time

    We are seeking a highly motivated and detail-oriented Regulatory Affairs Specialist to join our team at Sarah Cannon Research Institute (SCRI), a leading oncology research organization. In this role, you will play a crucial part in ensuring regulatory compliance for industry sponsors and/or sites in networks.About the RoleAs a Regulatory Affairs Specialist,...


  • The Woodlands, United States Lifelancer Full time

    About the RoleWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Sarah Cannon Research Institute (SCRI), a subsidiary of McKesson.As a Regulatory Affairs Specialist, you will play a crucial role in managing and planning regulatory affairs compliance for industry sponsors and/or sites in networks. You will work closely with the...


  • The Woodlands, United States Epic Travel Staffing Full time

    Job OverviewEpic Travel Staffing is seeking a highly skilled Cardiac Cath Lab Tech to join our team for a 13-week assignment.Compensation and BenefitsThe estimated weekly rate for this position is $2233 per week. Additionally, you will receive a comprehensive benefits package, including day one health insurance coverage, 401(k) matching program, weekly...

  • Payroll Specialist TX

    2 weeks ago


    the woodlands, United States Creative Financial Staffing Full time

    The Payroll Specialist position involves responsibilities related to processing and managing employee payroll using UKG. Here are the typical job responsibilities, required skills, and qualifications for a Payroll Specialist using UKG software: Perks of the Payroll Specialist role? Visible & Direct point of contact with Director of Payroll Services Career...

  • Payroll Specialist TX

    2 weeks ago


    the woodlands, United States Creative Financial Staffing Full time

    The Payroll Specialist position involves responsibilities related to processing and managing employee payroll using UKG. Here are the typical job responsibilities, required skills, and qualifications for a Payroll Specialist using UKG software: Perks of the Payroll Specialist role? Visible & Direct point of contact with Director of Payroll Services Career...


  • The Woodlands, United States MCKESSON Full time

    McKesson is an impact-driven, Fortune 10 company that touches virtually every aspect of healthcare. We are known for delivering insights, products, and services that make quality care more accessible and affordable. Here, we focus on the health, happiness, and well-being of you and those we serve - we care.What you do at McKesson matters. We foster a culture...


  • The Woodlands, United States GetMed Staffing, Inc. Full time

    Job OpportunityAbout the RoleWe are seeking a skilled Diagnostic Imaging Specialist to work in our Cath Lab. The ideal candidate will have experience with various imaging modalities and be proficient in patient care.This is a 13-week contract position, working 40 hours per week with flexible shifts of 10 hours. Our client values teamwork and camaraderie,...


  • The Woodlands, United States Entergy Full time

    Posting End Date:  Work Place Flexibility: Hybrid Legal Entity: Entergy Services, LLC *This position can be filled as a Strategic Portfolio Planning Specialist I, II, III, or Senior depending upon the candidate's qualifications and experience.* JOB SUMMARY/PURPOSEProvide a range of market and technical analyses to support the Entergy Operating...


  • The Woodlands, Texas, United States beBee Professionals Full time $60,000 - $80,000

    Company Overview:At beBee Professionals, we strive to deliver exceptional healthcare services through a dedicated team of professionals.About the Role:We are seeking a skilled Respiratory Care Specialist to join our travel team in The Woodlands. As a key member of our team, you will provide high-quality respiratory care to patients in various healthcare...


  • The Woodlands, United States Partnership Employment Full time

    Senior Benefits SpecialistRequired: Hands on Benefits experience Ability to work in the office located in The Woodlands, TX. 5 years of experience as HR GeneralistBachelor's Degree or Professional CertificationProvides advice to employees on benefit policies, practices, programs, and guidelines and identifies, researches, and resolves complex matters. Lead...


  • the woodlands, United States Partnership Employment Full time

    Senior Benefits SpecialistRequired: Hands on Benefits experience Ability to work in the office located in The Woodlands, TX. 5 years of experience as HR GeneralistBachelor's Degree or Professional CertificationProvides advice to employees on benefit policies, practices, programs, and guidelines and identifies, researches, and resolves complex matters. Lead...


  • the woodlands, United States Circle Logistics, Inc Full time

    Job Title: Regional Freight SpecialistCompany: Circle LogisticsLocation: The Woodlands, TXAbout Circle Logistics: Circle Logistics is a leading third-party logistics (3PL) company, specializing in providing customized transportation solutions to a diverse range of industries. We pride ourselves on delivering exceptional customer service, leveraging our...


  • The Woodlands, United States Circle Logistics, Inc Full time

    Job Title: Regional Freight SpecialistCompany: Circle LogisticsLocation: The Woodlands, TXAbout Circle Logistics: Circle Logistics is a leading third-party logistics (3PL) company, specializing in providing customized transportation solutions to a diverse range of industries. We pride ourselves on delivering exceptional customer service, leveraging our...


  • the woodlands, United States Creative Financial Staffing Full time

    The Payroll Specialist position involves responsibilities related to processing and managing employee payroll using UKG. Here are the typical job responsibilities, required skills, and qualifications for a Payroll Specialist using UKG software: Perks of the Payroll Specialist role? Visible & Direct point of contact with Director of Payroll Services Career...


  • The Woodlands, United States Houston Methodist The Woodlands Hospital Full time

    Job Summary">We are seeking a highly skilled Respiratory Care Practitioner to join our team at Houston Methodist The Woodlands Hospital. As a Respiratory Therapist - Pulmonary Specialist, you will be responsible for providing exceptional patient care and performing routine respiratory care procedures.">Responsibilities">">Perform diagnostic testing of the...


  • The Woodlands, United States Houston Methodist The Woodlands Hospital Full time

    At Houston Methodist, the Pharmacy Administrative Specialist position is an advanced pharmacist practitioner responsible for providing and coordinating pharmaceutical care to the patients of Houston Methodist through medication use evaluations, drug policy development, and continuous quality management activities related to his/her specialty focus area...


  • The Woodlands, United States Houston Methodist The Woodlands Hospital Full time

    At Houston Methodist, the Pharmacy Administrative Specialist position is an advanced pharmacist practitioner responsible for providing and coordinating pharmaceutical care to the patients of Houston Methodist through medication use evaluations, drug policy development, and continuous quality management activities related to his/her specialty focus area...


  • the woodlands, United States Texas Childrens Hospital the Woodlands Full time

    **Job Title:** Medical Care Specialist**Location:** Texas Children's Hospital The Woodlands**Salary Range:** $80,000 - $110,000 per yearCompany OverviewTexas Children's Hospital The Woodlands is a leading healthcare provider dedicated to delivering exceptional patient care and promoting health and wellness in the community.About the RoleWe are seeking a...


  • The Woodlands, United States Huntsman Full time

    Job Description:Strategic Category Lead - Corporate ServicesHuntsman Corporation is a publicly traded global manufacturer and marketer of differentiated and specialty chemicals. Our chemical products number in the thousands and are sold worldwide to manufacturers serving a broad and diverse range of consumer and industrial end markets. We operate more than...


  • the woodlands, United States TotalMed Allied Full time

    We are seeking a skilled Mobile Diagnostic Imaging Specialist to join our team at TotalMed Allied.As a Mobile Diagnostic Imaging Specialist, you will be responsible for providing top-notch imaging services to patients in The Woodlands, Texas.About the JobJob Title: Mobile Diagnostic Imaging SpecialistLocation: The Woodlands, TexasDates: Starting on...