Clinical Research Associate - Alzheimer's (Remote anywhere in Northern Midwest)

Location: Morrisville, North Carolina, United States

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This position is no longer open.

Requisition Number: 727

Position Title: Senior Clinical Research Associate

External Description:

Worldwide is global leader in CNS clinical research with unrivaled experience. From psychiatry and neurology to analgesia and addiction drug development, our expertise spans translational medicine through registration studies and peri-approval activities including registries and other observational research that have a pharmacoeconomic intent. Whether a compound is an original small molecule, injectable large molecule or a bioequivalent generic—our neuroscience experts are true specialists.

Our Clinical Research Associates (CRA) are home-based and have 8 on-site days monthly. They are responsible for site qualification, initiation, interim monitoring, site management and study close-out visits for studies in accordance with Good Clinical Practices (GCPs) and applicable local and international regulations and Standard Operating Procedures (SOPs). Ensure quality of data submitted from study sites and assure timely submission of data, including appropriate reporting and follow-up for all safety events by site personnel.

This particular role will focus on CNS, specifically Alzheimer's Disease.

 RESPONSIBILITIES:

  • Write site visit trip reports
  • Compile and ensure completeness of regulatory documents and ethical submission documentation as appropriate and required (e.g. IRB / IEC study approval, informed consent, etc.)
  • Coordinate study material (e.g. CRFs, manuals) shipment and receipt by study site
  • Document site visit findings via written reports
  • Review study subject safety information and informed consent
  • Conduct source document verification for compliance, patient safety, and veracity of data
  • Review CRFs using paper or electronic data capture systems and assist sites with data query resolution
  • Maintain regular communication with sites

 
REQUIREMENTS:

  • Requires a bachelor’s degree or a two-year nursing degree
  • A minimum of 2 years’ field monitoring experience required
  • CNS monitoring experience required
  • Recent experience monitoring Alzheimer's/Dementia trials required
  • Willingness to travel required
  • Valid current passport required
  • Driving license required
  • Fluent in the local languages of the countries under responsibilities and proficient in both spoken and written English

    Worldwide Clinical Trials is an Equal Opportunity Employer

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City:

State: Minnesota

Employment Type: Contractor

Community / Marketing Title: Clinical Research Associate - Alzheimer's (Remote anywhere in Northern Midwest)

Company Profile:

We’re a global, mid-size CRO that pushes boundaries, innovates and invents — because the path to a cure for the world’s most persist diseases is not paved by those who play it safe, but by those who take pioneering, creative approaches, and implement them with quality and excellence. We are experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs, in the best possible way.

Location_formattedLocationLong: Morrisville, North Carolina US

CountryEEOText_Description: Worldwide Clinical Trials is an equal opportunity employer, dedicated to a policy of non-discrimination in employment on any basis including age, sex, color, race, creed, national origin, religion, marital status, sexual orientation, political belief or disability.

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