United BioSource Corporation.

Sr Clinical Research Associate - Home based in Germany

Location
Homeworking
Salary
Competitive
Posted
07 Jan 2021
Closes
06 Feb 2021
Ref
2412
Discipline
Clinical Research
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)


UBC are looking for a CRA/SCRA with at least 2 years monitoring experience – home based in Germany. You may be working on late phase studies, clinical trials or a combination of both. Ideally, we are looking for someone with experience in oncology and late phase studies but this is not essential. At UBC you will also be directly involved in site contract and budget negotiations.

This is a great opportunity for a CRA from a large CRO background to gain new skills if you have no previous experience. If you are looking to gain new skills and exposure to other phases with reduced travel, UBC may be just the place for you!

Brief Description:

Monitors in accordance with ICH, GCP, CFR guidelines, local and study specific guidelines and regulations and UBC and project SOPs

Requirements:
  • Bachelor’s degree – Life Science preferred or equivalent years of industry and monitoring experience or relevant working experience
  • At least 2 years active monitoring in Germany (DACH) Experience in electronic CTMS, EDC, eTMF
  • Good written and verbal communication skills in English and local language
  • Minimum travel –approximately 40% depending on study allocation
  • Thorough knowledge of clinical trials methodology and medical terminology
  • Thorough knowledge of ICH-GCP
  • Ability to work independently
  • Excellent organizational and time management skills


Supervisory Responsibilities:

Mentoring new and/or junior CRAs.

Specific Job Duties:
  • Thorough knowledge of German legislation applicable to clinical trials/ observational studies and ICH GCP
  • Involvement in Feasibilities and Startup of studies assigned
  • Responsible for all aspects of Site Management and Monitoring of clinical studies from initiation through close out, including onsite visits and remote monitoring
  • Completion of visit reports and tracking in CTMS and other systems within requested timelines
  • On site /remote monitoring visits
  • May be required to support/ mentor junior CRAs
  • Preparation, submission and tracking of local ethics committee and other regulatory applications
  • Contract and budget negotiation with hospitals and local R&D Departments
  • Study feasibility assessments where required
  • Working with a local and international project teams
  • Responsible for data review as per project specifications
  • Review and maintenance of regulatory documents as per study and local requirements
  • Liaise between the sites and project teams and establish good communication and relationship


ABOUT UBC

United BioSource Corporation (UBC) is a leading provider of pharmaceutical support services, partnering with life science companies to make medicine and medical products safer and more accessible. Our services support the full lifecycle of medicine and medical products, including development, commercialization, and long-term value and safety.

While UBC offers employment within Patient Support, Nursing, Pharmacy and Corporate, two main focus areas for the company are Clinical Development & Research and Safety & Risk Management. Members of the Clinical Development and Research teams help evaluate study protocol, target study population, recruit physicians and patients, and collect, clean, validate and report data. As a result, sponsors are able to submit findings to regulatory authorities or make a no-go decision in a timely and clear-cut manner. Additionally, our Safety and Risk Management teams develop, deliver, and report evidence to reinforce safe and appropriate product use.

Through our Patient Access services, we help patients begin therapy quickly and remain on therapy, building strong relationships with patients to ensure optimal care.
You can find out more by visiting

www.ubc.com

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