Senior Clinical Research Associate - CRO - Remote

Company: Sarah Cannon Network
Location: Nashville
Posted on: June 25, 2022

Job Description:

DescriptionIntroductionAre you passionate about the patient experience? At Sarah Cannon Development Innovations, we are committed to caring for patients with purpose and integrity. We care like family! Jump-start your career as our remote Senior Clinical Research Associate today with Sarah Cannon!BenefitsWe are committed to providing our employees with the support they need. At Sarah Cannon Network, we offer eligible colleagues an attractive benefit package that includes medical, wellbeing, dental and vision benefits along with other unique benefits including:

• Medical, Dental, Vision, Life Insurance and Flexible Spending
• Paid Time Off (PTO) and Personal Leave
• 401K (100% annual match - 3% to 9% of pay based on years of service)
• Academic Assistance and Reimbursements for Tuition and Student Loans
• Employee Discounts including Tickets, Retail, Mental Health Apps, Education Apps, Identity Theft Protection etc.
• Home, Auto, and Pet Insurance
• Employee Stock Purchase Program (ESPP)
• Short Term & Long Term Disability coverage
• Adoption Assistance
• Legal Benefits and lots more!Learn more about Employee BenefitsCome join our team as our remote Senior Clinical Research Associate. We care for our community! Just last year, Sarah Cannon and our HCA Healthcare colleagues donated $13.8 million dollars to charitable organizations. Apply Today!Job SummaryThe Senior Clinical Research Associate (Sr. CRA) will be a key member of the team and will utilize their knowledge as a resource to help other CRAs develop their skills. The Sr. CRA will provide expert advice, guidance and general supervision to clinical monitoring team activities for designated projects, and to monitor specified sites to ensure quality and integrity of data, compliance with Sarah Cannon or sponsor standard operating procedures (SOPs), monitoring plan (MP), International Conference on Harmonization (ICH), Good Clinical Practice (GCP), regional specific regulatory requirements, ensuring study completion on time and within budget. They may be called upon to interact independently with sponsors involved in their projects, and to assist in some relevant departmental tasks and initiatives.The Sr. CRA is an essential member of a Development Innovations project team responsible for the execution of a clinical research project. The degree of responsibility given to a Sr. CRA shall reflect his/her experience and the level of contribution, which he/she can make to that project.This position will focus on the on-site monitoring of Early Phase Oncology trials (Phase I-II).Duties include and are not limited to
  • Serve as the primary point of contact for investigative sites.
  • Conduct all activities according to the defined project-specific quality and performance standards as well as relevant SOPs, ICH/GCP, and region-specific requirements
  • Serve as a mentor within the organization, working with others to help them organize their time efficiently.
  • Has in-depth knowledge of ICH/GCP and region-specific regulations and begins to give guidance to junior CRAs on applying this knowledge to the practice of monitoring.
  • May perform CRA assessment and training visits per SOPs.
  • Assist in the development and delivery of departmental trainings.
  • Able to give practical guidance on application of systems, processes, and regulations.
  • Actively participate in training sessions and workshops, including presenting reports from any conferences attended.
  • May be involved in bid defense meetings, kickoff meetings and other sponsor presentations.
  • Ensure awareness of project-specific quality and performance standards (within Development Innovations Monitoring Standards) and ensure that these are adequately documented, communicated, and understood.Serve as a subject matter expert (SME) within Development Innovations for these standards.
  • Assist in the development of patient recruitment strategy.
  • Maintain awareness of current developments in phase I-III oncology studies relative to assigned projects.
  • 60%-80% travel, including overnight stays, is required and may involve travel to meetings or attendance at conferences. In addition, weekend and evening travel may be required depending upon the workload and nature of current programs.
  • Able to visualize the goals set within the team and Clinical Monitoring Department and works proactively to achieve the project deliverables.Qualifications needed
    • Bachelor Degree required
    • At least three years of CRA experience at a contract research organization (CRO) or sponsor company monitoring clinical trials at investigative sites with experience in Phases l - ll.
    • Have performed all visit types (PSV, SIV, RMV, and COV).
    • Demonstrated leadership skills.
    • Demonstrated successful high performance in CRA II competencies for candidates with less than 3 years of experience.
    • Ability to travel 60%-80%.Preferred experience includes
      • At least five years of CRA experience at a contract research organization (CRO) or sponsor company monitoring clinical trials at investigative sites with direct oncology monitoring experience in Phase l - ll in solid and liquid tumor types
      • Have performed all visit types (PSV, SIV, RMV, and COV)
      • Previous experience in a Sr. CRA role.
      • Lead CRA experience.
        Sarah Cannon is the Cancer Institute of HCA Healthcare. We offer integrated cancer services with easy access to cutting-edge therapies for communities across the United States and United Kingdom. Sarah Cannon's cancer programs include individualized patient navigation. Our nurses are oncology-trained. More than 1,200 stem cell transplants are performed yearly within the Sarah Cannon Blood Cancer Network. Through its services, Sarah Cannon provides state-of-the-art cancer care for hundreds of thousands of patients. Our cancer experts are collaborating and sharing best practices. We address every aspect of the cancer journey, from screening and diagnosis through treatment and survivorship.HCA Healthcare has been named one of the World's Most Ethical Companies by Ethisphere Institute for over a decade. In recent years, HCA Healthcare spent an estimated $3.7 billion in cost for the delivery of charitable care, uninsured discounts, and other uncompensated expenses."The great hospitals will always put the patient and the patient's family first, and the really great institutions will provide care with warmth, compassion, and dignity for the individual."- Dr. Thomas Frist, Sr.
        HCA Healthcare Co-FounderIf you are looking for an opportunity that provides satisfaction and personal growth, we encourage you to apply for our remote Senior Clinical Research Associate opening. We promptly review all applications. Highly qualified candidates will be contacted for interviews. Unlock the possibilities and apply today!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.CORP-AFHP

Keywords: Sarah Cannon Network, Nashville , Senior Clinical Research Associate - CRO - Remote, Healthcare , Nashville, Tennessee