CROMSOURCE

Clinical Research Associate, Sweden - P

7 days left

Company
CROMSOURCE
Location
Sweden
Salary
Competitive
Posted
04 Feb 2021
Closes
06 Mar 2021
Ref
HQ00002442
Discipline
Clinical Research
Hours
Full Time
Contract Type
Contract
Experience Level
Experienced (non-manager)
Description:
TalentSource Life Sciences, the division of CROMSOURCE dedicated to flexible resourcing solutions, is currently searching for a Clinical Research Associate to be dedicated to one of our partner companies - an international pharmaceutical company, with focus on Respiratory, Paediatrics, Rare Disease and Special Care Therapeutic Areas.

An exciting new freelance opportunity to work with a mid-sized pharma company, providing full site management from feasibility to close out. This will be for 1 site only and estimated around 0.2-0.3 FTE, with more time needed at the start of the feasibility period, starting asap and then reducing as the study goes into steady state. The is a paediatric study with the potential to work on other studies if and when they arise.

As this is a client-facing role, we are looking for confident candidates with strong management skills and the ability to work independently whilst establishing a high-trust environment with the client counter-parts.

Job specific tasks and responsibilities:
  • Assists in the selection of sites, site evaluation visits, initiation visits and ensuring follow up by obtaining the pre-study documentation to ensure good start-up of the investigation sites
  • Performs training of site staff in all study procedures in order to ensure protocol/ICHGCP compliance
  • Conducts and reports periodic monitoring visits in the field and reviews at each visit accuracy, eligibility, completeness and quality of Case Report Form (CRF) in compliance with the protocol, SOP's and ICH-GCP requirements in order to ensure data integrity and subject safety
  • Adapts and translates Patient Information Leaflets and Informed Consent Forms
  • Cooperates with the site staff and Sponsor for ensuring a proper reporting from the site of the safety issues (adverse events and adverse reaction such as AEs/SAEs, SUSARs, etc.) and their follow up, guaranteeing timely and appropriate handling of safety issues
  • Assist in contract negotiation with sites on study budget after appropriate and documented training
  • May support the submission process in the project (or region)
  • May present study materials at Investigator/study launch meetings when required
  • Assist project management team with review of study documents when required


Education, Experience and Skills:
  • University Degree in scientific, medical or paramedical discipline
  • Prior experience as a CRA and site management
  • Experience with phase 2/late phase studies & paediatrics a plus
  • Experience with rare diseases
  • Experience with ERT a plus
  • Excellent knowledge of clinical trial operations, ICH-GCP Guidelines and other applicable regulatory requirement
  • Fluent in English and local language
  • Proficiency in Microsoft Office (e.g. Word, Excel, Outlook
  • Willingness to travel


Who will you be working for?

About CROMSOURCE

CROMSOURCE is a family owned international, full-service Contract Research Organisation who, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. The successful growth of CROMSOURCE has been achieved by putting high quality and client focus at the heart of everything we do.

Our Company Ethos

Our employees are the most valuable company asset. We value our resources and ensure they work in a friendly, family environment so they are able to develop their skills and talents. Human Resources is the fulcrum around which all CROMSOURCE activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values are evidenced by our below industry average turnover rates.

About TalentSource Life Sciences

TalentSource is the division of CROMSOURCE dedicated to flexible staffing solutions. Through us, you will have the opportunity to be integrated into a sponsor-led team, whilst having the continuous support from your Line Manager, who will work closely with you to mentor and support your professional development and growth. For our client-facing positions, you must be confident, be able to drive the role and work autonomously.

The Application Process

Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.

If you would like to discuss the role before applying through the website @ https://www.talentsourcelifesciences.com/job-information/?job-id=HQ00002442

or please contact Rocio.EgeaMota@cromsource.com for more information.

CROMSOURCE is an equal opportunities employer. All qualified applicants will receive consideration for employment in relation to race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran or military status or any other legally protected status. CROMSOURCE is also committed to compliance with all fair employment practices regarding citizenship and immigration status.

Keywords: Clinical Research Associate, Freelance, Freelancer
Skills: Paediatric, Rare Disease, Freelance, Feasibility, GCP, Late Phase, MS Office, Regulatory Location: Sweden Share:

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