Position and Landos Statement
The Clinical Trial Coordinator (CTC) is a highly motivated individual, self-starter with an A+ attitude and proven ability to follow through who will be involved in managing agile/lean clinical operations. The position will be expected to manage a number of tasks and projects simultaneously. This position will be responsible for performing diverse responsibilities requiring sound judgment, problem solving skills and a working knowledge of all study-specific synopses, protocols, TMFs, and CRFs.
Landos is a clinical stage biotech and the candidate will be completely aligned with three fundamental pillars of Landos’ corporate culture: 1) Be bold and decisive, 2) Never give up, and 3) Do the impossible.
ESSENTIAL DUTIES AND RESPONSIBILITIESinclude, but are not limited to the following
- Will serve as the centralized point of contact for communication regarding clinical trials in the start-up process.
- Assist in the oversight of CROs performance, third party vendors, and field CRAs including monitoring, to ensure compliance with study protocol and in accordance with scope of work and in accordance with corporate timelines; identify areas of concern and escalate to appropriate point of contact.
- Will work with general guidance from supervisor to implement clinical trials through pre-site selection, SRC review, IRB approval, collaboration with ancillary departments, creation of protocol orders and other source documentations and finally SIV and protocol activation. Assist in preparing Clinical Study Reports and annual safety reports.
- Work collaboratively with specific departments to help maintain appropriate documents.
- Verify the accuracy and completion of documentation including but not limited to, subject eligibility checklist, source documentations, drug dispensing logs, subject screening logs, and study-related communication.
- Review reports for accuracy, completeness and conformance with SOPs.
- May monitor/audit clinical sites for adherence to protocol and GCP, including: conducting site pre-qualification, initiation, monitoring visits, and close-out visits or co-monitoring visits conducted by CRO personnel.
- Assurance of regulatory compliance of investigational sites with company SOPs, EMA/FDA and ICH guidelines.
- Perform clinical data review of data listings and summary tables, including query generation.
- Review and/or submission of research ethics committee/regulatory documentation.
- Develop and maintain good working relationships with investigators and study staff.
- Ensure studies are carried out according to the study protocol, SOPs, and ICH/GCP regulations and study-specific manuals and procedures.
- Assist with establishing and tracking clinical timelines and appropriate performance metrics.
- Manage/oversee investigational product (IP) accountability and reconciliation process.
- Responsible for review or approval of IP release packages.
- Update/maintain electronic copies of documents/templates used for clinical trial management and department operations.
- Create/prepare clinical trial tracking/status reports.
- Assist in preparation/formatting/finalization of clinical study documents, contracts and related attachments, reports, meeting minutes and correspondence.
- Collect/review/track site regulatory documents.
- Serve as primary/secondary contact for clinical sites and vendor personnel as delegated
- Prepare/maintain study-specific Trial Master Files (TMF). Periodically review TMF content to ensure completeness.
- Manage clinical supply (re)order process and inventory. Respond to (acknowledge receipt/fill) order requests in a timely manner.
- Participate in project specific meetings and coordinate department meetings.
- Maintain department calendars and perform other administrative duties as needed.
- Any other tasks required by the position supervisor or the company’s management.
- BS/BA in clinical science or related discipline.
- Demonstrated expertise at maintaining regulatory compliance.
- Performs consistently beyond expectations.
- Maintains a high degree of accuracy and attention to detail while performing the Company’s work.
- Health insurance
- Dental insurance
- Vision insurance
- Paid time off
- Flexible schedule
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