Sr. Clinical Research Associate
Company: Kelly Services
Posted on: April 9, 2021
Sr. Clinical Research AssociateJob DescriptionThe Sr. Clinical
Research Associate manages study activity from site selection,
start-up, to close-out with adherence to regulations, maintaining
data integrity, and aligning deliverables with corporate goals. As
a key contributor to the Global Clinical Operations team, this
position develops and assesses SOPs, assesses processes for
efficiency and compliance. This position requires the ability to be
detail-oriented, organized, and productive with a keen interest in
medical device and biologics research.RESPONSIBILITIES:
- Independently manage all phases of a clinical study including
protocol, CRF, and monitoring plan development, essential document
management, contract execution, IRB/EC support, recruitment, site
payment reconciliation and development of site tools.
- Conducts Qualification, Site Initiation, Interim, and Close-Out
monitoring visits to ensure adherence to monitoring plan, protocol,
- Train site personnel regarding the protocol and applicable
- Ensure each site is meeting its goals of follow-up rate, data
clean deadlines, protocol compliance, and enrollment.
- Lead study meetings to ensure completion of established project
team goals and objectives, including study training and data
- Facilitate corrective action assessment and maintain TMF in
- Provide study status updates to Management team and develop
sufficient resolution of identified action items.
- Contribute to annual reports, data management, data analysis,
and publication support.
- Develop and assesses SOPs annually, as needed. Maintain current
knowledge of applicable US and international clinical regulations
and guidance documents.
- Participate in department systems and development initiatives
including related trainings.
- Support investigator meetings as needed.
- Support Protocol Deviation and Adverse Event review and
- Maintain credentialing requirements at hospitals and clinics as
needed. Complete projects and tasks consistent with corporate
- Support the Clinical Operations team in general and with
various improvement projects. Perform other duties as
- Contribute to the company culture of being collaborative,
respectful, transparent, ethical, efficient, high-achieving, and
- Bachelor's--degree preferably in natural sciences or related
field, or related practical experience.
- At least 7 years of clinical research experience, medical
device experience preferred. US IDE, IND, and OUS experience
- Ability to foresee and prevent risks and understand when to
elevate issues to management and recommend corrective action.
- Excellent time management skills.
- Ability to recognize potential obstacles and develop solutions
to resolve them with minimal consequence within set timelines or
change direction if priorities are modified.
- Ability to make critical, independent decisions and be
accountable for actions within a fast-moving environment.
- Ability to perform at high-level with limited supervision and
effectively partner with team members when necessary.
- Ability to exercise critical thinking skills in selecting
methods, techniques, and evaluation criteria.
- Proficient in Microsoft Word and Excel, and the ability to
quickly learn other software tools and applications, such as
- Ability to develop strong relationships with investigative
- Ability to travel approximately 20-75 to attend meetings,
perform training and monitoring.--Why Kelly--?Kelly Science &
Clinical is your connection to premier scientific and clinical
companies looking to hire talented people just like you. Every day,
we match science professionals with dream jobs that fit their
skills and interests-it's the way we think job searching should be.
Nearly 100 percent of our science recruiters have a professional
background/education in science, so we know a thing or two about
the science market and how to get you noticed.About Kelly--At
Kelly, we're always thinking about what's next and advising job
seekers on new ways of working to reach their full potential. In
fact, we're a leading advocate for temporary/nontraditional
workstyles, because we believe they allow flexibility and
tremendous growth opportunities that enable a better way to work
and live. Connecting great people with great companies is what we
do best, and our employment opportunities span a wide variety of
workstyles, skill levels, and industries around the world. Kelly is
an equal opportunity employer committed to employing a diverse
workforce, including, but not limited to, minorities, females,
individuals with disabilities, protected veterans, sexual
orientation, gender identity. Equal Employment Opportunity is The
Keywords: Kelly Services, Cary , Sr. Clinical Research Associate, Other , Apex, North Carolina
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