What are the responsibilities and job description for the Clinical Research Associate - CNS (Southeast) position at Worldwide Clinical Trials?
We're uncommon. A willingness to take the road less traveled to meet the demands of your trial isn't always accepted by CROs, but at Worldwide, we're committed to your specific needs. We never take a "one size fits all approach."
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 Pain Management.
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 degree or a two-year nursing degree
- A minimum of 2 years field monitoring experience required
- CNS experience required, Pain Management experience is a plus
- 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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