Covance Clinical Research Coordinator in Leeds, United Kingdom
Covance is currently looking for a Clinical Research Coordinator in Leeds. Permanent full time.
As CRC you will responsible for:
Overall accountability for the operational conduct of assigned studies, working closely with the Project Manager, Principal Investigator and operational staff and ensuring that all studies are conducted in accordance with regulatory and protocol requirements, and standard operating procedures whilst maintaining the safety and integrity of the study .
The Clinical Research Coordinator is the primary site contact for the Project Manager (PM) communicating any potential issues and assists in taking appropriate action in response to these issues, ensuring that client requirements and timelines are always met or exceeded.
Independently undertakes routine studies and more complex studies with guidance. May coach and mentor Operations coordinators and junior staff.
(40%) Study Set-up – Performs all aspects of the set up process to include the development and approval of study specific documents, study schedules and clinical procedure planning
(30%) Coordination - 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 investigators and Project Manager including adverse event updates
*(20%) Study Meetings -Facilitates/attends and contributes to all key Study Planning meetings, i.e. Clinical Start Up Meeting, Clinical Planning Meeting, Site Initiation Meeting
*(10%) Protocol Review – 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. May distributes final protocols and amendments to the site
Study Planning – Proactively works with the site to ensure that the laboraratory, 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
Complaints – handles participant complaints efficiently and effectively in order to maintain customer satisfaction.
- Clients – 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.
- Training - Deliver/facilitate study specific training
Learns and develops Clinical skills to perform study tasks and performs procedures as necessary
Participant eligibility – verifies eligibility for Panel Selection and at Pre dose by determing 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
Create/manage study specific shipping calendar ensuring biological samples are shipped as directed by the client in a timely manner
*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
Works with Recruitment/Screening to define a recruiting plan ensuring that the study is recruited on schedule, updating Project Manager on a regular basis
Consult with pharmacy staff to ensure awareness of receipt inventory, accountability and disposal of clinical trial materials
Assist with on time source document completion and query process
Authorizes study participant stipend payments as required
Performs other related duties as assigned
¨ Typically a minimum 3-4 years’ 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
Education / Qualifications
University/college degree (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, typically 3 years experience in related field (e.g. pharmaceutical, laboratory, data analysis) will be considered in addition to the experience requirement.
Typically 1-2 years of professional work experience, must include clinical research or related experience.
Basic knowledge of computer and programs (e.g. Microsoft Word, Excel).
Knowledge of drug development process, ICH Guidelines and GCP.
Job Number 2019-29083
Job Category Clinical Operations Entry Level
Position Type Full-Time
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