Clinical Research Associate - CNS
Location: North Carolina, United States
Requisition Number: 2106
Position Title: Senior Clinical Research Associate
Our 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 Non-Alcoholic Steatohepatitis (NASH).
- 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
- Requires a bachelor’s degree or a two-year nursing degree
- A minimum of 2 years’ field monitoring experience required
- Monitoring experience in NASH, Hepatocellular Carcinoma, Hepatitis A, B, C, Cirrhosis of Liver, or Fatty Liver is required
- Willingness to travel required
- Valid current passport required
State: North Carolina
Employment Type: Contractor
Community / Marketing Title: Clinical Research Associate - CNS
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: Research Triangle Park, 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.