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Senior Clinical Research Associate

Company: Sarah Cannon BMT Clinic at MVH
Location: Las Vegas
Posted on: November 12, 2019

Job Description:

Description SHIFT: Work From Home

SCHEDULE: Full-time

Senior Clinical Research Associate - Work From Home
Sarah Cannon Development Innovations--is a full-service contract research organization (CRO) that is uniquely focused in oncology. Sarah Cannon Development Innovations offers strong scientific leadership, access to patients through Sarah Cannon Research Institute---s Site Management Organization (SMO) and relationships with other clinical sites, and experience in drug development and delivery of clinical trials from First-In-Man through registration level studies, making us the partner of choice for oncology.
Our differentiator is strong operational delivery in partnership with our Site Management Organization and physician leaders to deliver your program efficiently.
Sarah Cannon Development Innovations works with Sarah Cannon Research Institute--strategic and network sites throughout the United States, along with investigators at sites outside of the Sarah Cannon Research Institute--network. This reach allows Sarah Cannon Development Innovations to offer sponsors access to a diverse and varied patient population, spanning multiple tumor types and disease stages. These relationships further enhance the depth and breadth of Sarah Cannon Development Innovations--- therapeutic expertise, enabling it to provide focused, strategic operational support. This support ensures that clinical trials are conducted in a timely manner and reported with high-quality, registration-standard data.
Sarah Cannon,--the global cancer enterprise of Hospital Corporation of America (HCA), offers integrated cancer services with convenient access to cutting-edge therapies for those facing cancer in communities across the United States and United Kingdom.

**This is a Work From Home position and you can be located anywhere inthe United States to be eligible for this role.

Summary of Key Responsibilities:The Senior CRA is a high-profile role within the department; using their experience as a knowledge resource to help--other CRAs develop their skills. The 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 SCRI or client---s standard operating procedures (SOPs), clinical monitoring plan,--ICH GCP, regulatory requirements, ensuring study completion on time and within budget. They may be called upon to--interact independently with clients not directly involved in their projects, and to assist in some relevant departmental--tasks.
The Senior 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 Senior CRA shall reflect his/her experience and the level--of contribution, which he/she can make to that project.--
Duties include but are not limited to:Duties include but are not limited to:

  • Conduct all activities according to the defined project-specific quality and performance standards as well as relevant SOPs, ICH/GCP, and local requirements
  • Contribute to the departmental on-site Quality Control program by setting a schedule of site assessment visits for the project for agreement with the Services Monitoring Management Team, and conducting agreed co-monitoring visits with members of the Services Monitoring project team.
  • Ensure awareness of project-specific quality and performance standards (within Services Monitoring Standards) and ensure that these are adequately documented, communicated, and understood.
  • To be accompanied by Project Manager, Project Lead, or CRA Manager on selected visits (qualification, initiation, monitoring, and close out visits.)
  • Actively participate in training sessions and workshops, including presenting reports from any conferences attended
  • Assist in the Investigator selection and qualification process.
  • Assist in the development of patient recruitment strategy.
  • Attendance at Investigator Meetings.
  • Perform and document pre-study site evaluations, site initiations, regulatory document collection, interim monitoring and study close out visits in accordance with GCP, study-specific requirements, clinical monitoring plans, company SOPs, applicable regulatory requirements and defined quality and performance standards.
  • Ensure site IRB approval is current and all IRB documentation is in order.
  • Maintain site monitoring schedule and serve as the principal point of contact for investigational sites.
  • Document and report on clinical study progress, i.e. patient recruitment and discuss potential opportunities and risks with respective Project Team members.
  • Ensure patient safety is maintained and informed consent procedures are carried out
  • Provide training and update investigative site team of any changes in study conduct and documentation requirements.
  • Ensure continued acceptability of the investigator, clinical site team and facility.
  • Review clinical data, source documentation, CRF, and investigative site regulatory files.
  • Work closely with data management and site to resolve discrepancies.
  • Ensure investigational product accountability accuracy and oversee investigational product inventory.
  • Liaise with vendors such as central --laboratories as required to ensure protocol adherence and ensure investigational sites have appropriate clinical supplies
  • Meet with clinical study sponsor representatives, as requested.
  • Submission of routine monitoring visit reports and follow-up letters as per required timelines
  • Ensure resolution of issues with investigative sites
  • Maintain strictest confidentiality.
  • Throughout the conduct of the clinical trial assesses adherence to SCRI SOPS, GCP and all applicable regulatory requirements.
  • Travel is required. May also involve travel to meetings or attendance at conferences. Overnight stays may also be required. In addition, weekend and evening sessions may be required depending upon the workload and nature of current programs
    Qualifications Qualifications--
    Education:Minimum Required:--Bachelor's College Degree (4 year program)Preferred: Bachelor's College Degree (4 year program)
    Experience: Minimum Required:
    • Three years direct oncology monitoring experience in Phases l - ll--
    • Have performed all visit types (site evaluation/selection, initiation, routine monitoring, andclose-out)
    • Demonstrated leadership skillsPreferred:
      • At least five years direct oncology monitoring experience in Phase l --- lll in solid and liquidtumor types--
      • Have performed all visit types (site evaluation/selection, initiation, routine monitoring, andclose-out)--
      • Demonstrated leadership skills--
      • Previous experience in a Senior CRA role, preferredDo you find this opportunitycompelling, if so we encourage you to apply? We promptly review allapplications. If you are highly qualified you will hear from one of ourrecruiters. We are actively interviewing so apply today.
        Weoffer you an excellent total compensation package, including competitivesalary, excellent benefit package and growth opportunities. We believe in ourteam and your ability to do excellent work with us. Your benefits include 401k,PTO medical, dental, flex spending, life, disability, tuition reimbursement,employee discount program, employee stock purchase program and student loanrepayment. We would love to talk to you about this fantastic opportunity.
        We are an equal opportunity employerand value diversity at our company. We do not discriminate on the basis ofrace, religion, color, national origin, gender, sexual orientation, age,marital status, veteran status, or disability status.
        Notice Our Company---s recruiters are here to help unlock the next possibility within your career and we take your candidate experience very seriously. During the recruitment process, no recruiter or employee will request financial or personal information (Social Security Number, credit card or bank information, etc.) from you via email. The recruiters will not email you from a public webmail client like Gmail or Yahoo Mail. If you feel suspicious of a job posting or job-related email, contact us

        Company Description:

        HCA Healthcare is a collaborative healthcare network, driven by physicians, nurses and colleagues helping each other champion the practice of medicine to give people a healthier tomorrow. With a comprehensive network of more than 270,000 people across approximately 1,800 care facilities, our scale enables us to deliver great outcomes for our patients, provide superior nursing care and be a preferred place for physicians to practice medicine. We never stop in our pursuit of insights and care advances based on the knowledge and data we gain from approximately 30 million patient encounters a year. Every day, we raise the bar to improve the way healthcare is delivered, not just in our facilities, but everywhere. We---re committed to improving more lives in more ways, and above all else, we are committed to the care and improvement of human life.

Keywords: Sarah Cannon BMT Clinic at MVH, Las Vegas , Senior Clinical Research Associate, Healthcare , Las Vegas, Nevada

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