Sr Clin Res Assoc

Our mission - bringing medical miracles to market sooner - impacts the lives of millions of people all over the world. Our current growth of Clinical Development Services (CDS) in Eastern European countries brings new opportunities not only for clinical roles, but also another business functions.

CoSource, our insourcing division provides you with the opportunity to work directly for our clients. For these roles you will either work out of our client offices or field based – and see clinical trials from the clients' perspective. We work in partnership with global and smaller pharmaceutical companies and can support you in your career development.
At the moment we are looking for:
Clinical Research Associates on different levels – CRA II and Senior CRA with oncology Experience , ready to work on complex oncology trials

(home-based, with a requirement to spend 4 days a month in Client's office,
preferred start date-1st March 2016)

As CRA you will be 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;

- 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
- Assures the implementation of project plans as assigned
- Function as leader for projects of limited scope as assigned
- Assume line management responsibilities as assigned
- Act in the project role of as Local Project Coordinator or Lead CRA as assigned

Your main duties:
- 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:
o Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study
o Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements
o 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
o 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
- Prepare accurate and timely trip reports
- Manage small projects under direction of a Project Manager/Director as assigned
- Serve as lead monitor for a protocol or project and may assist in establishing monitoring plans as assigned
- Review progress of projects and initiate appropriate actions to achieve target objectives
- Organize and make presentations at Investigator Meetings
- Report, write narratives and follow-up on serious adverse Experience s
- Participate in the development of protocols and Case Report Forms as assigned
- Participate in writing clinical trial reports as assigned
- Interact with internal work groups to evaluate needs, resources and timelines
- Act as contact for clinical trial supplies and other suppliers (vendors) as assigned
- 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 as assigned
- Negotiate study budgets with potential investigators and assist the Covance legal department with statements of agreements as assigned
- Complete process of 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, mentoring and development of new employees, e.g. co-monitoring
- Co-ordinate 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

EEO Employer Covance is committed to diversity in the workplace and is an equal opportunity employer (Minority/Female/Individual with Disability/Veteran/Sexual Orientation/Gender Identity). Your confidentiality and privacy are important to us.
Regional, CZE
Regional, Czech Republic