Lead Clinical Research Associate
Meadowbrook Estates, Maryland
Expiry Date :
Fri, 06 Nov 2020 23:59:59 GMT
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The LCRA is responsible for the oversight and coordination of the monitoring and site management activities in clinical trials (phase I-IV) according to ICH-GCP and FDA CFR21.
The LCRA ensures that all deliverables related to monitoring activities meet time, quality and cost expectations as outlined in ICH-GCP, the monitoring plan and the contract with the Sponsor.
The LCRA also provides support to the PM and provides leadership to the Clinical Research Associates (CRAs) in the execution of the project related activities.
Directly reports to the CRA Manager
REASONABLE ACCOMMODATIONS MAY BE MADE TO ENABLE INDIVIDUALS WITH DISABILITIES TO PERFORM THE ESSENTIAL FUNCTIONS.
Serve as the main point of contact for the CRAs working under his/her supervision and ensure all study specific training for all CRAs is completed (done on time), properly documented and filed in the appropriate location
Responsible for monitoring performance metrics of the CRA team and ensure oversight of the performance of CRAs ensuring that deliverables are met to budget, time and quality
Track and manage the progress of monitoring and site management activities (site accrual and activation, monitoring progress, enrollment, etc.) and report updates to the IPM/CPM
Oversee adequate filing of all study related documents in (e)TMF. Follow up its inspection-ready status. The LCRA may have to supervise global filing activities.
Identify risks and issues that might delay or interfere with the activities or performance of the CRAs assigned to the project
Develop and update the monitoring plan and all necessary forms
Develop and/or review and update development of patient documents (subject information sheet, assent form, etc.), site agreements, and other study documents as delegated by the PM
Coordinate the execution of investigational site contracts in collaboration with the contract team, Contract Office or the regional legal team to ensure that all legal requirements are met
Initiate and ensure accuracy of site payment requests
Independently prepare and perform Investigator site visits relevant to the phase of the study (selection and qualification, initiation, regular monitoring or site closure) as specified in the Project and Monitoring Plan, if needed
Oversee management and reporting of site deviations, which includes CAPA follow up, trends identification and reporting to the Sponsor
Prepare and execute bid defense content related to site management and monitoring
Prepare project training documents for the Investigator Meeting in connection with monitoring and site related activities and present at the meeting
Supervises others: No, not directly but responsible for ensuring the team is on track through supervision and support of the CRA team.
Has hiring and terminating responsibilities: No
Number of employees directly reporting to this job:Supervisory Employees, 2-4 Non-Supervisory Employees
Supervise and support the team of CRAs assigned to the same project
Coordinate CRA resources and activities in reference to performance, quality, and timelines
Ensure CTMS training is completed by CRAs and study specific access is granted
Ensure that mandatory trial entries and updates are made in CTMS by CTA(s) and CRA(s)
Review and approve monitoring reports within timelines and follow up with CRAs to ensure action items resolution