Site Monitoring Lead - Ridgefield, United States - TruMinds Technologies
Description
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 onsite visits to assess CRA performance, including comonitoring/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. BI CTMS).
- Deliver Riskbased 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 inhouse 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).
Trial Conduct:
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.
Including but not limited to:
- Issue management / oversight on country level.
- Continuous review, risk identification, evaluation/ analysis and communication on a country level as applicable.
- Maintain Riskbased 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 followup actions and escalation, as required.
- In conjunction with SMLr, contribute to preparation and implementation of trial level documents including training material updates/retraining as needed.
- In conjunction with SMLr, facilitate communication and training related to site monitoring in the trial at the OPU:
- training as necessary.
- Participate, prepare input (as requested by SMLr) for Trial Oversight Meetings (country level) and contribute to the timely responses to questions from external and internal stakeholders.
Skills:
Oncology experience
metabolic experience
Dermatology experince
CNS experiecne
Keywords:
Education:
Bachelor's Degree (Health Sciences, Health Care, Nursing or Others) required with a 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.
Skills and Experience:
Required Skills:
PROJECT MANAGEMENT
CAPA
RISK ASSESSMENT
CLINICAL TRIAL MONITORING
DERMATOLOGICAL
Additional Skills:
CLINICAL SITE MONITORING
ONCOLOGY
CLINICAL MONITORING
Languages:
English
Read
Write
Speak
Minimum Degree Required:
Bachelor's Degree
Patents:
No
Publications:
No
Veteran Status:
No
of Positions: 1
Location:
Ridgefield, CT
900 RIDGEBURY RD BLDG AOB,
Pay:
$ $86.99 per hour
Benefits:
- 401(k)
- Dental insurance
- Health insurance
Schedule:
- Night shift
Ability to Relocate:
- Ridgefield, CT 06877: Relocate before starting work (required)
Work Location:
In person
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