US Tech Solutions · 20 hours ago
Site Monitoring Lead
Ridgefield, CT
Contract
Remote
Senior Level, Lead/Staff
$3,000/wk - $3,700/wk
5+ years exp
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Responsibilities
Accountable for the execution of monitoring plans & overall quality of monitoring performed by CRAs for assigned US conducted trials (~5-8) across Therapeutic Area(s) phase depending on complexity, size and stage of study.
Conduct on-site visits to assess CRA performance, including co-monitoring/supervisory visits, as requested, including oversight of CRAs working on assigned trials.
Implement the monitoring plan as part of the Trial Team. Monitor clinical monitoring deliverables for assigned trials in clinical operations system(s)(e.g. CTMS).
Deliver Risk-based Site Monitoring approach and local training for the trial.
Develop and provide appropriate training of local trial teams (e.g. Clinical Trial Managers (CT Manager) and Clinical Research Associates (CRA)).
Assist with in-house Site Monitoring inspection readiness activities and lead preparation for US site regulatory inspections, as requested.
Behave as local expert and consultant on site management and monitoring topics.
Participate in and contribute to global/regional and local Trial Team meetings, international/ regional / local Investigator Meetings.
Timely responses to Site Management and monitoring questions from external and internal stakeholders (including Regulatory Authority/Ethics Committee).
Monitor progress and oversee Site Management and Monitoring activities conducted by CRO partners during clinical trial conduct including adherence to ICH-GCP, and regulatory requirements, compliance with SOPs, trial protocol, trial quality management and Site Monitoring plans.
Issue management / oversight on country level.
Continuous review, risk identification, evaluation/ analysis and communication on a country level as applicable.
Maintain Risk-based Site Monitoring approach for the OPU and provide feedback on the trends identified that may impact the TLMM and/or site monitoring oversight plan.
Conduct Site and Monitoring Oversight (including Site Monitoring Oversight Visits) at OPU according to plan, implement follow-up actions and escalation, as required.
In conjunction with SML-r, contribute to preparation and implementation of trial level documents including training material updates/retraining as needed.
In conjunction with SML-r, facilitate communication and training related to site monitoring in the trial at the OPU:
Communication and training of CT Managers and CRAs. Performing re-training as necessary.
Participate, prepare input (as requested by SML-r) for Trial Oversight Meetings (country level) and contribute to the timely responses to questions from external and internal stakeholders.
Qualification
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Required
Bachelor’s Degree (Health Sciences, Health Care, Nursing or Others) required
Minimum of 5 years of experience performing on-site monitoring or 8 years of relevant business experience in the regulated pharmaceutical or healthcare industry, including on-site monitoring experience
Accountable for the execution of monitoring plans & overall quality of monitoring performed by CRAs for assigned US conducted trials (~5-8) across Therapeutic Area(s) phase depending on complexity, size and stage of study
Conduct on-site visits to assess CRA performance, including co-monitoring/supervisory visits, as requested, including oversight of CRAs working on assigned trials
Implement the monitoring plan as part of the Trial Team
Monitor clinical monitoring deliverables for assigned trials in clinical operations system(s)(e.g. CTMS)
Deliver Risk-based Site Monitoring approach and local training for the trial
Develop and provide appropriate training of local trial teams (e.g. Clinical Trial Managers (CT Manager) and Clinical Research Associates (CRA))
Assist with in-house Site Monitoring inspection readiness activities and lead preparation for US site regulatory inspections, as requested
Behave as local expert and consultant on site management and monitoring topics
Participate in and contribute to global/regional and local Trial Team meetings, international/ regional / local Investigator Meetings
Timely responses to Site Management and monitoring questions from external and internal stakeholders (including Regulatory Authority/Ethics Committee)
Monitor progress and oversee Site Management and Monitoring activities conducted by CRO partners during clinical trial conduct including adherence to ICH-GCP, and regulatory requirements, compliance with SOPs, trial protocol, trial quality management and Site Monitoring plans
Issue management / oversight on country level
Continuous review, risk identification, evaluation/ analysis and communication on a country level as applicable
Maintain Risk-based Site Monitoring approach for the OPU and provide feedback on the trends identified that may impact the TLMM and/or site monitoring oversight plan
Conduct Site and Monitoring Oversight (including Site Monitoring Oversight Visits) at OPU according to plan, implement follow-up actions and escalation, as required
In conjunction with SML-r, contribute to preparation and implementation of trial level documents including training material updates/retraining as needed
In conjunction with SML-r, facilitate communication and training related to site monitoring in the trial at the OPU
Communication and training of CT Managers and CRAs. Performing re-training as necessary
Participate, prepare input (as requested by SML-r) for Trial Oversight Meetings (country level) and contribute to the timely responses to questions from external and internal stakeholders
Preferred
Oncology experience
Metabolic experience
Dermatology experience
CNS experience
Company
US Tech Solutions
US Tech Solutions counted among the largest yet the fastest growing staffing firm; all achieved organically.
1001-5000 employees
H1B Sponsorship
US Tech Solutions has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2023 (13)
2022 (19)
2021 (22)
2020 (11)
Funding
Current Stage
Late StageLeadership Team
Manoj Agarwal
CEO/President
Recent News
GlobeNewswire News Room
2024-12-13
Company data provided by crunchbase
