Clinical Trial Assistant, San Diego, CA
Company: Kelly Services
Location: San Diego
Posted on: April 10, 2021
Clinical Trial Assistant, San Diego, CAShift: 1st, Monday-
FridayPay: $21-24/hourPosition Type: 2-3 monthsSUMMARY OF
- Assist in all clinical team activities for start-up, oversight,
and study closure to include coordinating the preparation and
assembly of clinical trial supplies and materials for distribution
to clinical sites with minimal/moderate supervision.
- Maintain related tracking information of all clinical
materials, shipments, and inventory.
- Assist the Data Management team in tracking and management of
Case Report Forms CRFs and Laboratory Submission Forms LSFs.
- Assist in maintaining files and tracking of all written and
electronic documentation for all study records and site
interactions in the Trial Master File TMF .
- Communicate with sites regarding query resolution to ensure
compliance with specified protocols and accuracy of submitted
- Participate in data entry, data auditing, clinical site queries
and overall clinical data flow from multiple clinical sites in a
timely and professional manner.
- Coordinate in-house specimen procurement studies.
- Willingness and ability to learn, understand and apply
regulatory guidelines and Good Clinical Practices GCP s applicable
to IVD and Medical Devices for conducting clinical field trials,
CLIA Waiver and 510 k submission studies.
- Be familiar with GCP, FDA regulations and relevant Standard
Operating Procedures for clinical research.
- Develop skill and knowledge with regulatory procedures and
become familiar with--product development procedures.
- Interact with study coordinators and in-house study
- Assist with data entry as necessary, and audit field clinical
trial data for inclusion in regulatory submissions.
- Help implement and maintain clinical trial tracking databases
for each clinical study.
- Responsible for maintaining Trial Master Files for all clinical
- Works closely with the clinical team to provide clinical
- May assist in the conduct of readability studies to validate
ease-of-use of test materials and reliability of draft
- Assemble and ship IUO kits and supplies for clinical
- May help clinical team identify clinical trial sites.
- Assists in the preparation for initiation of clinical studies
and monitors and tracks the progress of those studies via in-house
- Supports obtaining IRB study approvals through direct
communication with clinical sites enabling acquisition of required
regulatory submission documents.
- Recruit subjects for in-house specimen acquisition and
maintains necessary supplies for specimen acquisition in support of
- Works as a part of the clinical team, providing assistance to
aid in the execution of clinical plans for clinical field studies,
to include specimen procurement studies and in-house user
- Interacts via telephone and written communications with
physicians, nurses, physician assistants and study site personnel
at clinical trial sites.
- Assist with in-house specimen procurement with minimal
- Interacts with clinical team and regulatory staff to help
implement, oversee and closeout clinical studies.
- Assists with in-house monitoring and auditing of clinical data
during clinical field investigations in order to achieve 100
accuracy of clinical database.
- Works with Clinical team to assist in shipping and oversight of
material supplies of clinical and beta-site field trials.WORK
ENVIRONMENT:--Lab and office environment.EDUCATION, SKILLS
- BS/BA in any biological science or Medical Technologist degree
or equivalent combination education and/or work experience--
- 1-2 years progressive clinical research experience.
- Previous research or scientific technical experience in the
IVD, medical device or bio/pharma industry preferred.
- Prior experience or certification in clinical trial design,
Clinical Research Coordinator i.e. CCRC , and/or data management
experience highly desirableFor Immediate Consideration, Apply
Today! Questions? Call Grace at 714.253.7656, Email at
email@example.com, or--schedule a time to connect directly
follow the link:--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, San Diego , Clinical Trial Assistant, San Diego, CA, Other , San Diego, California
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