Senior Clinical Research Associate
Company: Sarah Cannon BMT Clinic at MVH
Location: Las Vegas
Posted on: November 12, 2019
Description SHIFT: Work From Home
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,
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
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
- 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
- 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
- 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
- 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
- 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
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 -
- 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
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
Keywords: Sarah Cannon BMT Clinic at MVH, Las Vegas , Senior Clinical Research Associate, Healthcare , Las Vegas, Nevada
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