Cerner Enviza is a leading global healthcare consulting firm and trusted advisor to many of the world’s top pharmaceutical, biotech, and medical device & diagnostic companies. By supporting the work of Cerner Enviza, you will work with world-class healthcare companies, helping them improve global access to medicines by connecting science and research. Cerner Enviza is passionate about our people, our business, and our clients and is proud to foster a culture that contributes to the health and well-being of humankind

With ongoing and ground-breaking developments in Oncology and Rare Disease, an increased focus on more scientific, targeted medicine and continuous integration of technology into development and delivery of medicine, there has never been a more exciting time to work in Life Sciences and, with Cerner Enviza immersed in all of these, there has never been a better time to join us and make a difference to our clients and the lives of patients.

The Lead Clinical Research Associate (CRA) is a critical hire for our business! The healthcare research space is becoming increasingly important, and you will have the chance be part of an industry that is continuing to evolve and grow. This is a great opportunity for someone with a few years of relevant experience to expand on their knowledge while working for a global corporation.

The Lead CRA will work closely with the Project Manager to lead the study site management activities according to GCP and relevant SOPs, ensuring the overall quality and timeliness of deliverables for assigned clinical and non-interventional studies.

The Lead CRA acts as the main contact person to our clients   and are responsible for the development of Monitoring plan and training material for CRAs and study sites and the preparation and/or review of essential study documents e.g. Patient Information and Informed Consent Form. 

The Lead CRA will coordinate and oversee a team of project-specifically assigned CRAs in different countries and train CRAs on general requirements for the conduct of monitoring activities as well as on study protocol, study-related procedures, adverse event reporting and regulatory documentation.

What we’ll offer

•    A competitive salary with exciting benefits

•    Flexible and remote working so you can do your best work

•    Learning and development opportunities to advance your career

•    An Employee Assistance Program to support your mental health

•    Employee resource groups that champion our diverse communities

•    Core benefits such as medical, life insurance, and access to retirement planning

•    An inclusive culture that celebrates what makes you unique

Basic Qualifications:

At least 4 years total combined related work experience and completed higher education.

Preferred Qualifications:

·       A minimum of 3 years of experience as Clinical Research Associate.

·       Broad knowledge of different therapeutic areas.

·       MS Office Suite (e.g., Word, Excel, PowerPoint).

Expectations:

·       Excellent organizational and communication skills.

·       Ability to interact professionally with all organizational levels.

·       Team player.

·       Ability to manage competing priorities in fast paced environment.

·       Strong problem-solving skills.

·       Read, write and speak fluent English, excellent verbal and written communication skills.

·       Willingness to travel on occasion.

 

Oracle is an Equal Employment Opportunity Employer. We don’t just value differences—we celebrate them. We’re committed to creating a workplace where all kinds of people work together. We believe innovation starts with diversity and inclusion.

Responsible for conducting applied research in scientific area of focus. Investigating applicable solutions through rigorous, protracted studies and ensuring that a quality, integrated solution is delivered in a timely manner, at budget, and to our client*s satisfaction. This involves working closely with the client to understand and manage their expectations, as well as working closely with Oracle and third-party vendors to ensure delivery.

Entry-level position for those who are new to consulting and are developing their expertise. Receives detailed instruction on routine work and is responsible for performing basic experiments and test on research topic and documenting results. As a member of a project team, follows standard practices and procedures to evaluate and analyze data, develop reports and presentations in external customer engagements. Uses available tools to analyze and solve problems for clients. May perform other duties as assigned.

Bachelors or Advanced degree in a discipline relevant to area of focus, plus 1 year related work experience. Minimum Qualifications: At least 4 years Total combined related work experience and completed higher education. Depending on the job there may be additional minimum requirements and/or preferred qualifications