Clinical Research Associate II

Allen Spolden

Phoenix, AZFull-time

Behavioral Health Market Context

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Benefits

Dental CoverageHealth Insurance

Job Description

ding to US and international guidelines.
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• Participate in the evaluation of potential clinical sites according to established criteria of acceptability.
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• Responsible for procurement of budgets, contracts, regulatory documents, and other administrative documents as related to clinical research functions.
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• Initiate studies performing initiation site visits, arrange for shipment of clinical supplies, case report forms, and other necessary materials.
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• Conduct ongoing study monitoring, including frequent periodic site visits, protocol adherence checks, material handling procedures, inspection of study files, and related monitoring functions.
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• Prepare site visit reports with identification of key accomplishments, key issues for resolution and recommendations for follow -up actions for assigned study sites.
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• Conduct study termination visits, obtain final reports from investigators, and participate in the preparation of final reports for regulatory submission.
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• Assist with the maintenance of clinical archive and electronic files.
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• Other tasks as assigned.
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Requirements<\/h3>

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
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• BA, BS, RN, BSN or equivalent
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• Basic knowledge and adherence to GCPs
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• 1 -2 years of clinical research experience or equivalent experience or training
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• Strong attention to detail
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• Ability to multi -task
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• Unquestionable integrity and highest ethical standards
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• Excellent written and verbal communication skills
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• Self -motivated, assertive, and driven
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Benefits<\/h3>Dental, Medical, Vision and 401K<\/div><\/span>

Qualifications

  • To perform this job successfully, an individual must be able to perform each essential duty satisfactorily
  • Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions
  • BA, BS, RN, BSN or equivalent
  • Basic knowledge and adherence to GCPs
  • 1 -2 years of clinical research experience or equivalent experience or training
  • Strong attention to detail
  • Ability to multi -task
  • Unquestionable integrity and highest ethical standards
  • Excellent written and verbal communication skills
  • <\/li>
  • Self -motivated, assertive, and driven

Benefits

    Responsibilities

    • Responsible for providing Clinical Research support for all clinical trials
    • Under the direction of supervisor or designee, this position will serve as support for the clinical study team
    • Participate and assist in design and preparation of protocols and case report forms
    • Generate clinical SOPs, policies, charters, and plans according to US and international guidelines
    • Participate in the evaluation of potential clinical sites according to established criteria of acceptability
    • Responsible for procurement of budgets, contracts, regulatory documents, and other administrative documents as related to clinical research functions
    • Initiate studies performing initiation site visits, arrange for shipment of clinical supplies, case report forms, and other necessary materials
    • Conduct ongoing study monitoring, including frequent periodic site visits, protocol adherence checks, material handling procedures, inspection of study files, and related monitoring functions
    • Prepare site visit reports with identification of key accomplishments, key issues for resolution and recommendations for follow -up actions for assigned study sites
    • Conduct study termination visits, obtain final reports from investigators, and participate in the preparation of final reports for regulatory submission
    • Assist with the maintenance of clinical archive and electronic files
    • Other tasks as assigned


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