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Clinical Research Coordinator

Employer
Labcorp
Location
Leeds, United Kingdom
Salary
Competitive
Start date
10 May 2021
Closing date
21 May 2021

View more

Discipline
Clinical Research, Clinical Operations
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Job Details


Covance by Labcorpis a leading global drug development services company providing support to the Pharmaceutical and Biotechnology industries. At Covance by Labcorp, we help make the miracles of medicine a reality. We offer opportunities to work on diverse, challenging projects with bright, interesting colleagues while building a flexible and rewarding career. This is your chance to become part of a team that helps to bring the miracles of medicine to market sooner.

About the Role

As a CRC, you would be responsible for the operational conduct of assigned studies, working closely with the Project Manager, Principal Investigator and operational staff, ensuring that all studies are conducted in accordance with regulatory, protocol requirementsand standard operating procedures whilst maintaining the safety and integrity of the study. You will provide leadership, training, coaching and mentoring for Clinical Operations staff.

Your main duties will include, but not be restricted to:
  • Coaches and mentors staff. Initiates, plans and implements appropriate staff development
    programs.
  • Demonstrate ability to lead by example and to encourage team members to seek solutions.
  • -Ensure the quality of service provided by team members meets the requirements of both
    internal and external clients.
  • Play an active role in the development and implementation of Quality within his/her area of
    responsibility.
  • Ensure that the staff under his/her supervision area at all times adequate in quality and quantity
    to meet the agreed forecasted workload. Recommend changes if necessary and justify them in
    accordance with company policy.
  • Performs all aspects of the study set up process to include the development and approval of study specific documents, study schedules and clinical procedure planning.
  • Coordinates the running of critical events, i.e. check in, PK days, check out by resolving/escalating issues identified by both staff and study participants. Monitors and maintains participant safety, dignity and compliance, including coordination of appropriate medical consultation/treatment as
    appropriate. Provides updates regarding study participants wellbeing to the I nvestigators and Project Manager including adverse event updates.
  • Facilitates/attends and contributes to all key Study Planning meetings, i.e. Clinical Start Up Meeting, Clinical Planning Meeting, Site Initiation Meeting.
  • Reviews protocols, provides consolidated comments from the clinical site on the draft study protocol to the Project Manager or Medical Writer, taking into account the logistics, safety (staff and study participants), and site's capabilities.
  • Pro-actively works with the site to ensure that the laboratory, equipment and all operational requirements are fulfilled and that the study is adequately resourced. Working closely with the Operations and Pharmacy to ensure dosing runs efficiently and that all documentation is completed accurately within a timely manner.
  • Handles participant complaints efficiently and effectively in order to maintain customer satisfaction.
  • Is aware of client expectations for trial conduct and works to meet or exceed them. Facilitates client visits, and attends client calls with the assistance of the Project Manager and/or site management where appropriate. Participates in Client and process Audits by covering study conduct questions.
  • Deliver/facilitate study specific training.
  • Learns and develops Clinical skills to perform study tasks and performs procedures as necessary.
  • Verifies participant eligibility for Panel Selection and at Pre-dose by determining whether protocol criterion has been met. Communicates with investigators and PM regarding study participant eligibility.
  • Oversees maintenance of study master file ensuring that site related documents are available for uploading to the eTMF.
  • Data Monitoring - Facilitate/coordinate monitoring visits and coordinate site resolution of
    any comments/queries raised.
  • Quality - Ensures all protocol deviations and or unscheduled events are properly
    documented and communicated.
  • Works with site management to maintain timely completion of issues raised from CQI's and client audits, implementing new processes where necessary

Get ready to redefine what's possible and discover your extraordinary potential at Covance by Labcorp. Here, you'll have the opportunity to personally advance healthcare and make a difference in peoples' lives with your bold ideas and unique point of view. With the support of exceptional people from across the globe and an energized purpose, you'll be empowered to own your career journey with mentoring, training and personalized development planning.Join us as we speed the delivery of ground breaking therapies and anticipate tomorrow's drug development challenges, creating new possibilities for our clients - and your career.
Education/Qualifications:
  • University/college degree desirable (life science, pharmacy or related subject preferred) or
    certification in a related allied health profession from an appropriately accredited
    institution (e.g. nursing certification, medical or laboratory technology).
  • In lieu of a degree, recent and relevant experience in a related field will be considered
Experience:
  • Substantial experience in a research environment.
  • Knowledge of protocol designs, study objectives and study procedures.
  • Knowledge of drug development process, ICH guidelines and GCP.
  • Excellent written and oral communication skills.
  • Ability to prioritize workloads.
  • Good organizational skills.
  • Previous customer service experience desirable.
  • Previous experience of coordinating people or processes desirable.

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Company

At Labcorp, we believe in the power of science to change lives. We are a leading global life sciences company that delivers answers for crucial health questions —because we know that knowledge has the potential to make life better for all. Through our unparalleled diagnostics and drug development capabilities, we provide insights and accelerate innovations that not only empower patients and providers but help medical, biotech, and pharmaceutical companies transform ideas into innovations. Here, you can join our more than 70,000 employees, serving clients in more than 100 countries, as we work together to make a real impact on people’s lives. Join us in our pursuit of answers.

 

 

 

 

Company info
Website
Location
Maidenhead Office Park
Westacott Way
Littlewick Green
Maidenhead
SL6 3QH
United Kingdom

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