SENIOR CLINICAL RESEARCH COORDINATOR
Company: US Tech Solutions
Location: Kansas City
Posted on: October 20, 2024
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Job Description:
Job Description:The Senior Clinical Research Coordinator (CRC)
is responsible for managing and overseeing the day-to-day
operations of clinical trials, recruiting and screening study
participants, as well as documenting and reporting on the daily
operations of assigned trials. Working in collaboration with the
Principal Investigator, the Sr. CRC is responsible for the
oversight, facilitation and coordination of the daily clinical
trial activities and plays a critical role in the conduct of the
study.The Sr. CRC works collaboratively with the entire team,
sponsors, and Clinical Quality Associates to ensure productivity,
quality, and timely completion of studies.The Sr. CRC is expected
to support, guide, train, demonstrate and lead clinical trial team
members in the implementation of trial related activities.The Sr.
CRC applies critical thinking and creative problem-solving skills
across a wide variety of clinical studies, and contributes to the
development of new processes, procedures, tools and training to
enhance clinical research activities and is accountable for
adhering to quality standards.Responsibilities:Manages and oversees
the day-to-day operations in the administration of clinical trial
activities at the site-level (i.e., direct interactions with study
participants)Regularly interfaces with current and potential
clinical trial participants to determine eligibility and consent of
study participants in alignment with clinical trial
protocol.Creates standard operating procedures (SOPs) that adhere
to all Food and Drug Administration (FDA) and Office for Human
Research Protections (OHRP) regulations.Contributes to the training
of clinical trial staff and accountable for compliance with the
operational requirements of the clinical trial.Function as
participants' primary point of contact, keeping them informed on
the study progress, and facilitate involvement of other study team
members, as needed (e.g., notify Principal Investigator of safety
events)Manage participant visit scheduling and technical
troubleshooting, escalating issues to the appropriate
individual(s)Solicit and record information regarding safety events
and preparing safety event documentation for review by the
Principal InvestigatorProvides accurate and timely data collection,
documentation, entry, and reporting in both Sponsor and
databases.Supports the regulatory staff in the maintenance of
regulatory documents in accordance with SOPs and applicable
regulations.Communicates and collaborates specific study
requirements to the research team, including internal and external
parties, sponsor, monitors, PI, and study participants.Maintain
regular contact with the Principal Investigator and team to review
study details (e.g., progress, adverse events, enrolment)Maintain
study supplies and issue appropriate participant stipends.Ensures
appropriate credentialing and training of the study team.Facilitate
meetings with the study monitors, auditors, and
investigators.Ensure timely response to queries and documentation
of study-related issues.If applicable, disburses investigational
product, manages inventory of equipment and study supplies, and
provides patient education regarding administration, as
necessary.Contribute to the development and implementation of
tools, processes, and training to enhance the administration and
execution of clinical studies (e.g., GCP, ALCOA-C)Accountable for
site compliance with subject safety reporting, escalate
issues.Demonstrate professionalism and apply basic leadership
practices in all aspects of the role.Train and support study team
members on a range of communication and teamwork best
practicesPerforms other duties related to the clinical trials as
delegated by the Principal InvestigatorExperience:3-5 years of
Clinical Trial experience.Skills:standard operating procedures
(SPOs), Food and Drug Administration (FDA), Clinical
Trials.Education:High School Diploma or associate degree.About US
Tech Solutions:US Tech Solutions is a global staff augmentation
firm providing a wide range of talent on-demand and total workforce
solutions. To know more about US Tech Solutions, please visit
www.ustechsolutions.com (http://www.ustechsolutionsinc.com) .US
Tech Solutions is an Equal Opportunity Employer. All qualified
applicants will receive consideration for employment without regard
to race, color, religion, sex, sexual orientation, gender
identity,national origin, disability, or status as a protected
veteran.
Keywords: US Tech Solutions, Kansas City , SENIOR CLINICAL RESEARCH COORDINATOR, Healthcare , Kansas City, Kansas
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