Covance Clinical Research Assistant in Munich, Delaware
Get ready to redefine what’s possible and discover your extraordinary potential at Covance. Here, you’ll have the opportunity to personally advance healthcare and make a difference in peoples’ lives with your bold ideas and unique point of view. 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.
Join us as we speed the delivery of groundbreaking therapies and anticipate tomorrow’s drug development challenges, creating new possibilities for our clients—and your career.
COVANCE is a leading global drug development services company and we provide support to the Pharmaceutical and Biotechnology industries. We have an exciting opportunity available to join our team.
We are currently recruiting Clinical Research Associate to join our Sponsor’s team
in Munich, Germany . This is a regular full-time position.
Duties and Responsibilities:
Act as contact for project team and study sites.
Perform CRF review, query generation and resolution against established data review guidelines, under direct supervision on Covance or client data management systems, as assigned by management.
Assist with generation and reconciliation of queries to investigative sites/clients to resolve problem data.
Assist with the management of study supplies and organize shipments.
Create, update, track, and maintain study-specific trial management files, tools, and systems.• Assist the local project team members with other administrative activities as required (e.g. payments to investigators, correspondence with clients, preparation of status reports, and organization of investigators’ meetings).
Co-ordinate meetings with clients, investigators, and project team, including taking minutes.
Ensure compliance with Covance S.O.P.s, FDA, ICH, and GCP regulations for clinical conduct in all aspects of daily work.
Provide input in writing Monitoring Conventions as assigned.
Assist in submissions and notifications to Ethics Committees and Regulatory Authorities.General On-Site Monitoring Responsibilities:
Assist Senior CRAs, CRA-2 and CRA-1 with on-site tasks as required and according to training goals (e.g. review of Case Report Forms and Study File Notebook, drug accountability).
Initiate, monitor and close out clinical investigative sites under direct supervision from Clinical Research Associates 1 and 2, Sr. Clinical Research Associates, Project Managers or Project Directors.
Perform other duties as assigned by management.
Education / Qualifications
Basic understanding of biology and biological processes.
University/college degree (life science, 5 yrs is preferred), or certification in a related allied health profession from an appropriately accredited institution• Good organizational and time management skills.
Good communication skills, oral and written.
Exhibit general computer literacy.
Works efficiently and effectively in a matrix environment.
Fluent in local office language and in English, both written and verbal.
One (1) or more years of experience in a related field, (i.e., medical, clinical, pharmaceutical, laboratory, research, data analysis, data management or technical writing).
Basic knowledge of ICH, FDA, IRB/IEC and other applicable regulations/guidelines; familiarity with investigator start up documents; previous interaction with operational project teams and investigative sites preferred
Ability to work with minimal supervision
Works well independently as well as in a team environment
Good planning and organization skills
Good computer skills with good working knowledge of a range of computer packages
Excellent verbal and written communication skills
Ability to work within a project team
Works efficiently and effectively in a matrix environment
Experience of Microsoft Word and Excel
Self-motivation with the ability to meet deadlines
Positive attitude and approach
Interact with internal customers with professionalism and discretion
Job Number 2018-24130
Job Category Administration/Clerical
Position Type Full-Time
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.