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.
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.
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 Alzheimer's Disease.
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
Perform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.
Requires a bachelor degree or a two-year nursing degree
A minimum of 2 years of 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
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.