Senior Clinical Research Associate

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Irfa******

  • Germany 
  • Last Update: 07.03.2020 at 12:00

Job Type
Full Time
Start
ASAP
Duration
6 Month +
Place
Munich, DE
Country
Germany

Description


Job summary

Covance is looking for the SCRA, sponsor dedicated for medical specialty studies, home-based

Essential Job Duties

Responsible for all aspects of study web site observance as well as routine observance and close-out of clinical sites, maintenance of study files, the conduct of pre-study and initiation visits; mediate with vendors; and different duties, as appointed.
Responsible for all aspects of web site management as prescribed within the project plans
General on-the-scene observance Responsibilities:
Ensure the study employees World Health Organization can conduct the protocol have received the right materials and directions to securely enter patients into the study
Ensure the protection of study patients by substantiating that consent procedures and protocol necessities area unit adhered to in line with the applicable restrictive necessities
Ensure the integrity of knowledge|the info|the information} submitted on Case Report Forms (CRFs) or different data assortment tools by careful supply document review. Monitor knowledge for missing or implausible knowledge
Ensure the resources of the Sponsor associate degreed Covance area unit spent with wisdom by activity the desired observance tasks in an economical manner, in line with SOPs and established tips, as well as managing travel expenses in a cost-effective fashion in line with Covance travel policy
Prepare correct and timely trip reports
Manage tiny comes beneath the direction of a Project Manager/Director as appointed
Serve as lead monitor for a protocol or project and will assist in establishing observance plans as appointed
Review the progress of comes and initiate applicable actions to attain target objectives
Organize and build shows at Investigator conferences
The report, write narratives and follow-up on serious adverse experiences
Participate within the development of protocols and Case Report Forms as appointed
Participate in writing clinical test reports as appointed
Interact with internal workgroups to judge wants, resources, and timelines
Act as contact for clinical test provides and different suppliers (vendors) as appointed
Responsible for all aspects of register management as prescribed within the project plans
Undertake feasibleness work once requested
Recruitment of potential investigators, preparation of European Union submissions, notifications to restrictive authorities, translation of study-related documentation, organization of conferences and different tasks as taught by supervisor as appointed
Negotiate study budgets with potential investigators and assist the Covance legal department with statements of agreements as appointed
The complete method of significant Adverse Event (SAE) news, method production of reports, narratives and follow from SAEs
Independently perform CRF review; question generation and determination against established knowledge review tips on Covance or shopper knowledge management systems as appointed by management
Assist with coaching, mentoring and development of recent workers, e.g. co-monitoring
Co-ordinate selected clinical comes as a neighborhood Project organizer (with supervising, if applicable), and will act as a neighborhood shopper contact as appointed
Perform different duties as appointed by management
Education/Qualifications:
University/college degree (life science preferred), or certification {in a|during a|in associate degree exceedingly|in a very} connected allied profession from an befittingly authorized establishment (e.g., nursing certification, medical or laboratory technology)

Experience:


Required expertise
In stead of the on top of demand, candidates with profound relevant clinical analysis expertise in pharmaceutical or cathode-ray oscilloscope industries could also be thought of
Fluent in German and English
Covance is committed to diversity within the geographic point associate degreed is an civil right leader (Minority/Female/Individual with Disability/Veteran/Sexual Orientation/Gender Identity). Your confidentiality and privacy area unit necessary to U.S..

Covance is proud to be associate degree civil right Employer:

As associate degree EOE/AA leader, the organization won't discriminate in its employment practices thanks to associate degree applicant's race, age, color, religion, sex, national origin, sexual orientation, personal identity, incapacity or veteran standing.
Seniority Level
Associate

Industry
Research Biotechnology prescribed drugs
Employment kind
Full-time

Job Functions
Research Analyst info Technology

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