Assistant Clinical Research Coordinator
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.
This position has no responsibility for line management of staff, however as the position is accountable for the operational conduct of critical events the post holder is required to supervise the study team and staff working on the study at these critical events.
Essential Job Duties:
- (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
- 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 considered
- 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
Labcorp is proud to be an Equal Opportunity Employer:
As an EOE/AA employer, the organization will not discriminate in its employment practices due to an applicant's race, age, color, religion, sex, national origin, sexual orientation, gender identity, disability or veteran status. For more information about how we collect and store your personal data, please see our Privacy Statement.