Premier Research
• $100K — $120K *Qualifications
Responsibilities
Benefits
This is a full-time contract position for 6 months.
What You'll Be Doing:
Delivers quality, timely monitoring reports for sponsor approval per the Clinical Monitoring Plan(CMP)timelines
Responsible for the validity, correctness, and completeness of the clinical data reviewed and collected at assigned sites as dictated by ICH GCP/ISO14155, protocol and client requirements
Monitors (remote, onsite or other approved mode of monitoring) with a focus on data integrity andsubjectsafety in accordance withlocal/regional laws andcountryspecificregulations
Plans day-to-day activities for monitoring of a clinical study and sets priorities per site
Prepares for and conducts onsiteand/or remotequalification, study initiation, interim monitoring,dosing observation,and closeout monitoring visitsasdirected per CMP
Works with the Clinical Lead or equivalent to enhance and proactively manage site visits and trial issues during the monitoring phase
What We Are Searching For:
Must be located in CA, NV, GA, or FL
Neuroscience monitoring experience highly prioritized
Undergraduate degree or its international equivalent in clinical, science, or health-related field from an accredited institution; a licensed health-care professional (i.e., registered nurse); or equivalent work experience required
Patient facing, study coordinating experience preferred
Knowledge of ICH-GCP/ISO14155, FDA Guidance Documents, EU Directives, local/regional regulations, and drug/device development and clinical monitoring procedures
Knowledge of clinical/health systems as well as knowledge of cultural/professional practicesappropriate tothe country/region where site monitoring activities will be conducted
Ability to multitask and work effectivelywith technology and peoplein a fast-paced environment with changing priorities, self-starter
Travel up to 70-85%
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