Senior Clinical Research Associate - CNS - Alzheimer/Dementia - Central/Midwest
Multiple Locations: Austin, TX, USA • King of Prussia, PA, USA • New York, NY, USA • Massachusetts, USA • Connecticut, USA • Vermont, USA • Texas, USA • New Jersey, USA
Notice
Requisition Number: 2443
Position Title: Senior Clinical Research Associate
External Description:
Our Senior Clinical Research Associates (CRA) are home-based. 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 with Alzheimer's Disease or Dementia is required.
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:
- Bachelor’s Degree,
- RN plus experience may be considered in lieu of a bachelor’s degree
- 5+ years as a regional (traveling) CRA with a CRO
- Experience in CNS with Alzheimer's Disease or Dementia is required
- Conducts all types of visits – PSSVs, SIVs, IMVs, and COVs
- Responsible for site management
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City:
State: Texas
Employment Type: Contractor
Community / Marketing Title: Senior Clinical Research Associate - CNS - Alzheimer/Dementia - Central/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: Austin, Texas US
CountryEEOText_Description: Worldwide is an equal opportunity employer that is committed to enabling professionals from all backgrounds and experiences to succeed and, to that end, we prioritize attracting diverse talent and cultivating an inclusive environment that encourages collaboration and creativity. We provide equal employment opportunities to all employees and applicants regardless of race, color, ethnicity, ancestry, religion, national origin, gender, sex, gender identity or expression, sexual orientation, age, citizenship, marital or parental status, disability, military status, or other class protected by applicable law. Worldwide is committed to working with and providing reasonable accommodations to applicants with disabilities. We are proud to be an equal opportunity workplace where people thrive by being themselves and are inspired to do their best work every day.