Clinical Research Associate

Location: 

Basel Area - Allschwil, BL, CH

 

 

About Idorsia Pharmaceuticals Ltd

Idorsia Ltd is reaching out for more - We have more ideas, we see more opportunities and we want to help more patients.

In order to achieve this, we will develop Idorsia into one of Europe’s leading biopharmaceutical company, with a strong scientific core.

Headquartered in Switzerland - a European biotech hub - Idorsia is specialized in the discovery and development of small molecules, to transform the horizon of therapeutic options. Idorsia has a broad portfolio of innovative drugs in the pipeline, an experienced team, a fully-functional research center, and a strong balance sheet – the ideal constellation to bringing R&D efforts to business success.

Idorsia was listed on the SIX Swiss Exchange (ticker symbol: IDIA) in June 2017 and has over 600 highly qualified specialists dedicated to realizing our ambitious targets.

 

 

Job Responsibilities

 

  • Review and provide input on study-related documents
  • Contribute to the collection and the quality control of essential documents required for a study
  • Perform initiation visits for the assigned studies
  • Schedule and conduct routine monitoring visits and close-out visits at the frequency determined for assigned studies, assuring that the CROs/Sites are delivering high quality research, overall integrity of study implementation, and adherence to the protocol at the clinical sites
  • Ensure that the conduct of the assigned studies complies with ICH Guidelines, local regulations, and Standard Operating Procedures (SOPs)
  • Identify CRO/Site issues, ensure resolution, and/or escalate issues if necessary
  • Manage the assigned CRO/Site(s) through regular contacts to ensure: Site compliance with regulatory requirements and ethical standards throughout the study, adequate enrolment, and understanding of study requirements
  • Manage all study supplies, including (but not limited to) IMP and laboratory supplies, from receipt to return or destruction, as appropriate
  • Ensure timely eCRF completion, if applicable, and proactively identify any data discrepancies by remotely reviewing the eCRF data
  • Ensure that query resolution is completed in a timely manner and supervise database lock in collaboration with the Clinical Pharmacologist and the Data Scientist
  • Ensure set-up and maintenance of the Investigator Site File

 

 

Candidate’s Requirements

 

  • University degree in science or health-related discipline and/or degree in Nursing
  • Minimum 1-2 years clinical research experience in a Contract Research Organization (CRO) or Pharmaceutical Company with experience in monitoring on-site clinical trials
  • Strong knowledge of ICH-GCP guidelines and other applicable regulatory requirements
  • Understanding of drug development process
  • Good organizational skills including proven ability to manage multiple activities and to set priorities
  • Ability to work independently as well as being a team player and with a keen attention to details
  • Able to deal with difficult situations with good problem-solving capabilities
  • Very good interpersonal skills (able to motivate the site staff and implement the study successfully)
  • Excellent oral and written communication skills in English
  • Willing to travel as required

 

 

What Idorsia offers

 

  • Exciting opportunities for development and professional growth within our dynamic organization
  • A collaborative and solution oriented environment where you can make a difference
  • An innovative and open culture in a truly multicultural environment
  • A competitive salary and generous social benefits

 

 

Work  Location: Allschwil

Country: Switzerland

Business Area: Global Clinical Development

Schedule: Fulltime

Job Type: Permanent

Job ID: 1360

 

If you are interested, please click on apply now.

Please be informed that if you are selected for this position, your employment will be subject to a pre-employment background screening process, of which you would be informed in greater detail in due course.

Please note Idorsia operates a strictly-controlled list of preferred recruitment partners. For those partners who have no valid, signed Master Service Agreement in place with Idorsia all unsolicited resumes, CVs, anonymous profiles, or any other candidate details submitted through our website or to personal e-mail accounts of employees of Idorsia Pharmaceuticals (including any of its subsidiaries, affiliates or related companies) are considered the property of Idorsia Pharmaceuticals and are not subject to payment of any form of introduction, placement or referral fees.