CR25 - Clinical Research Associate II (CRA II)
Company: Kelly Services
Posted on: September 20, 2019
In-House CRA II
- Responsible for clinical study activities for multiple clinical
sites for several to many ongoing clinical studies.
- Conduct clinical monitoring site visits (primarily local) and
monitor clinical trials in compliance with Standard Operating
Procedures, Good Clinical Practices (GCP) and applicable government
regulations and guidelines, appropriate communications between site
and sponsor, and deliverables as assigned by sponsor.
- May assist in coordinating protocol, informed consent, and case
report form development and compilation.
- May assist with study material distribution.
- Conduct clinical monitoring of study sites, ensuring test
article accountability, human subject protection, and protocol
adherence at investigational sites.
- Review, retrieve, and report the trial data as the requirements
dictate or as appropriate.
- Ensure all work-related activities and decisions embody the
clients core values.
- Verify safety and wellbeing of study subjects are maintained
for assigned study sites.
- Support the operational execution of clinical trials and ensure
collection of high quality, substantiated data.
- Execute clinical trials activities following established
standard operating procedures, good clinical practices, and
- Assume accountability for study site performance, providing
high quality data according to overall project timeline.
- Assist Clinical Operations staff and study site staff to
quickly and effectively resolve issues.
- Respond to problems and assists in implementing corrective and
- Verify Investigator Site Files at assigned Study Sites are
maintained according to regulations and/or
- Support patient recruitment and retention activities. Performs
Site visits and ensures study site is compliant with Study Protocol
and all Federal, State, local and company regulations, policies and
- Assist with internal communication of important clinical data
- Support, when required, organization of investigator and other
study training meetings.
- Function as a reliable, trusted resource of accurate,
up-to-date study site status knowledge as requested by key
- May be involved in other tasks to support Clinical Operations
and Operating Company as needed.
- Support the implementation of new clinical
- Interface and collaborate with investigators, IRB's/EC's,
contractors/Vendors and company personnel as needed.
- Bachelor of Science Degree, preferably in Life Science,
Physical Science, Nursing or Biological Science.
- 3-5 years of working experience as a clinical research
associate with working knowledge of regulations and standards
applied in clinical area and medical devices.
- Medical device experience required.
- Therapeutic area experience (ophthalmologic, not optometric)
- Strong knowledge, understanding and application of principles,
concepts and practices of clinical investigations/studies.
- Strong organizational, analytical, oral and written
- Ability to collect and analyze data and ability to flexibly
adjust to a dynamic working environment.
- Equipment: Must be able to operate personal computer, printer,
telephone, facsimile, copier, calculator; and be familiar with
Microsoft office products, software as required.
Why Kelly--?The Managed Solutions practice within Kelly Outsourcing
and Consulting Group (KellyOCG--) is one focus within the full
array of Kelly Services-- workforce solutions.
Kelly Services has transformed from the staffing industry pioneer
to a leading workforce solutions provider. KellyOCG is the
distinguished outsourcing and consulting segment of Kelly Services,
known for applying a forward-looking approach that enables
companies to make strategic workforce planning decisions that
impact their business and competitive advantage.
The Managed Solutions practice area of KellyOCG is dedicated to
partnering with clients to architect and implement solutions that
put them in a position to meet their operational obligation to
their organization and freedom to focus on their more strategic
Kelly Services--As a workforce advocate for over 70 years, we are
proud to have a role in managing employment opportunities for more
than one million workers around the globe. We employ 550,000 of
these individuals directly with the remaining workers engaged
through our talent supply chain network of supplier partners.
Revenue in 2015 was $5.5 billion. Visit kellyservices.com and
connect with us on Facebook, LinkedIn and Twitter.
Kelly Services is an equal opportunity employer including, but not
limited to, Minorities, Females, Individuals with Disabilities,
Protected Veterans, Sexual Orientation, Gender Identity and is
committed to employing a diverse workforce. Equal Employment
Opportunity is The Law.
Keywords: Kelly Services, Jacksonville , CR25 - Clinical Research Associate II (CRA II), Healthcare , Jacksonville, Florida
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