Worldwide is a global leader in CNS clinical research with an unrivaledexperience. 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 CRAs are home-based with 8 days on site monthly. Worldwide offers a wide range of industry-best benefits that include 4 weeks PTO, 10 paid holidays and matching 401(k).
To be considered for the Senior CRA role, candidates must have at least 5 years of experience in field monitoring 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). Our Senior CRAs are responsible for the quality of data submitted from study sites. In addition, Senior CRAs must assure timely submission of data, including appropriate reporting and follow-up for all safety events by site personnel.
Experience in CNS is required for the role. Alzheimer's or Dementia experience is a plus.
The Senior CRA will...
Perform feasibility studies for potential sites as requested
Conduct pre-study, study initiation and interim monitoring visits in adherence to the protocol requirements; conduct site visit trip report review and provide feedback and edits
Function in the role of Lead CRA for global studies by coordinating CRAs; provide mentoring and guidance to less experienced CRAs and site staff when needed
When needed, develop a Clinical Monitoring Plan and design study-specific tools and templates
Actively participate in study team, investigator meetings, and bid defenses
Compile and ensure completeness of regulatory documents and ethical submission documentation as appropriate and required (e.g. IRB / IEC study approval, informed consent, etc.
Review CRFs using paper or electronic data capture systems and assist sites with data query resolution
Conduct source document verification for compliance, patient safety, and veracity of data
Provide applicable updates for site related documentation for filing in the Trial Master File (TMF)
Work with Project Management to evaluate deliverables and study milestones
Other skills and abilities:
Excellent oral and written communication, organizational, problem-solving and interpersonal skills
Ability to provide experience and input into process initiatives and development relating to monitoring and site management activities
Extensive understanding of clinical research principles, process, and standard operating procedures
Thorough understanding of FDA and/ or EU Directives and regulations, ICH Guidelines and local regulatory requirements
Proficiency with IxRS, EDC systems
Bachelor Degree with a concentration in medical, biological, physical, health, pharmacy or other related science and a minimum experience of 5 years as a Clinical Research Associate, OR
Associate Degree with a concentration in nursing (or equivalent life science degree) and a minimum of 7 years of experience as a Clinical Research Associate
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
The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive. Promotion to the next level is not automatic based on years of experience. Individuals are evaluated on proven competency, level of responsibility, and ability to work independently.
Telecommuting is allowed.
About Worldwide Clinical Trials
Worldwide is the first customer-centric CRO. Founded by physicians dedicated to advancing medical science and built on an unwavering commitment to operational excellence, we are able to strategically balance science, medicine, operations, and commercial intelligence to achieve successful drug development.
We take a never satisfied approach. Tackling every clinical research program as an opportunity to demonstrate a deep commitment to each client’s unique needs. Combining therapeutic expertise – most notably in Neuroscience, Cardiovascular, Immune-Mediated Inflammatory Disease, and Rare Disease – with proactive insights and rigorous operations, we successfully manage clinical trials across more than 60 countries.
Our mission is to foster the development of life-changing medicines by integrating clinical trial methodology, operational acumen, and efficient technology.