Come join our team as an Assistant Clinical Research Coordinator!
(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
– *(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
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, typically 3 years' experience in a related field will be consideredExperience:
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
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