Covance Clin Res Assoc II in Sao Paulo, Brazil
We are seeking Clinical Research Associates II who have experience with oncology clinical studies. In this role you will be fully dedicated to working with one of our clients. All field monitoring will be done within Brazil.
If you are ready to redefine what’s possible, and discover your extraordinary potential at Covance then apply immediately. A career here provides the unique chance to create a lasting impact and difference in our patient’s lives. Joining our team will offer you a rewarding career, an opportunity to work in a high-energy & collaborative workplace, along with access to comprehensive benefits. Your work will be meaningful, the patient outcomes are real, and the results are lasting. With the support of exceptional people from across the globe and an energized purpose, you’ll be empowered to own your career journey with mentoring, training and personalized development planning.
Our mission is to help our clients bring the miracles of medicine to market sooner -- join us for your next career move.
Position is office based in Sao Paulo, Brazil. Oncology experience required.
Assures the implementation of project plans as assigned
Site administration and site monitoring responsibility for clinical studies according to Covance
Standard Operating Procedures, ICH Guidelines and GCP
Site management responsibility for clinical studies according to Covance Standard Operating
Procedures, ICH Guidelines and GCP
Act in the project role of as Local Project Coordinator or Lead CRA as assigned
Responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits; liaise with vendors; and other duties, as assigned
Responsible for all aspects of site management as prescribed in the project plans
General On-Site Monitoring Responsibilities:
Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study
Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements
Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review. Monitor data for missing or implausible data
Ensure the resources of the Sponsor and Covance are spent wisely by performing the required monitoring tasks in an efficient manner, according to SOPs and established guidelines, including managing travel expenses in an economical fashion according to
Covance travel policy
Travel, including air travel, may be required and is an essential function of the job.
Prepare accurate and timely trip reports
Responsible for all aspects of registry management as prescribed in the project plans
Undertake feasibility work when requested
Recruitment of potential investigators, preparation of EC submissions, notifications to regulatory authorities, translation of study-related documentation, organization of meetings and other tasks as instructed by supervisor
Negotiate study budgets with potential investigators and assist the Covance legal department with statements of agreements as assigned
Complete Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs
Independently perform CRF review; query generation and resolution against established data review guidelines on Covance or client data management systems as assigned by management
Assist with training, of new employees, e.g. co-monitoring
Coordinate designated clinical projects as a Local Project Coordinator (with supervision, if applicable), and may act as a local client contact as assigned
Perform other duties as assigned by management
Travel Requirements: Yes (% of time : 60%)
Language Skills Required: Speaking: English and Local Language; Writing/Reading: English and Local Language
University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure) and a minimum of 2 years of Clinical Monitoring experience.
In lieu of the above education requirement, external candidates with a minimum of 4 years recent clinical monitoring experience will be considered.
Internal Candidates: Internal candidates with a minimum of 2 years of clinical monitoring experience.
Thorough knowledge of ICH Guidelines and GCP including a basic understanding of regulatory requirements in other countries
Thorough understanding of the drug development process
Fluent in local office language and in English, both written and verbal Preferred:
Thorough knowledge of Covance SOPs regarding site monitoring
External Candidates: University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure) and a minimum of 2 years of Clinical Monitoring experience.
In lieu of the above education requirement, external candidates with a minimum of 6 years recent clinical monitoring experience will be considered.
Internal Candidates: Internal candidates with a minimum of 4 years of clinical monitoring experience.
Have a full understanding of Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs
Advanced site monitoring skills
Advanced study site management skills
Advanced registry administration skills
Ability to work with minimal supervision
Good planning and organization skills
Good computer skills with good working knowledge of a range of computer packages
Advanced verbal and written communication skills
Ability to train and supervise junior staff
Ability to resolve project-related problems and prioritizes workload for self and team
Ability to work within a project team
Works efficiently and effectively in a matrix environment Preferred:
One (1) or more year’s additional experience in a related field (i.e. medical, clinical, pharmaceutical, laboratory, research, data analysis, data management or technical writing) is preferred
Local project coordination and/or project management
Job Number 2019-28158
Job Category Clinical Research Associates
Position Type Full-Time
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