Senior Clinical Research Associate, Neuroscience (Contract)

Premier Research

$100K — $120K *
US-AnywhereRemote in United States
Healthcare
Less than 5 years of experience
Job Overview by Ladders

Qualifications

  • Located in CA, NV, GA, or FL.
  • Prioritized experience in neuroscience monitoring.
  • Undergraduate degree in a clinical, science, or health-related field, or equivalent work experience.
  • Preferred experience in patient-facing or study coordinating roles.
  • Knowledge of ICH-GCP/ISO14155 and FDA Guidance relevant to clinical trials.
  • Understanding of local regulations and cultural practices for site monitoring.
  • Self-starter with strong multitasking abilities and adaptability to changing priorities.
  • Willingness to travel 70-85%.

Responsibilities

  • Deliver timely monitoring reports according to Clinical Monitoring Plan timelines.
  • Ensure validity and completeness of clinical data at assigned sites according to ICH GCP and protocol.
  • Monitor trial data with a focus on integrity and subject safety per regional regulations.
  • Plan and prioritize day-to-day monitoring activities for clinical studies.
  • Conduct on-site and/or remote visits such as qualification, initiation, and monitoring checks.
  • Enhance management of site visits and issues in collaboration with Clinical Lead.

Benefits

  • Full-time contract for 6 months.
Full Job Description
Senior Clinical Research Associate, Neuroscience (Contract) to join our Clinical Monitoring, Site Management and SSU team.

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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