Clinical Research Associate & Documentation Specialist

Location: 

Basel Area, Allschwil, 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

 

CRA-Tasks regarding allocated studies (50%):

  • Review and provide input on requested study-related documents and on any CRO-prepared documents: e.g., protocol and protocol amendment, contract, Informed Consent, defined task of the Delegation of Authority, Case Report Form, Study-Specific Monitoring Plan (SSMP), study forms, source documents, Clinical Study Report
  • Contribute to the collection and the quality control of essential documents required
  • Perform initiation visits as agreed with the Clinical Pharmacologist for the assigned studies
  • Schedule and conduct routine monitoring visits and close-out visits at the frequency determined for the 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 all study supplies, including (but not limited to) IMP and laboratory supplies, from receipt to return or destruction, as appropriate
  • Supervise biological samples shipment(s) from the CRO/Site to the bioanalytical laboratory or central laboratory (when appropriate)
  • Ensure timely eCRF completion and query resolution, if applicable, and proactively identify any data discrepancies by remotely reviewing the eCRF data
  • Responsible for Trial Master File (TMF) maintenance
  • Follow relevant quality control procedures to verify that the quality requirements for the trial-related activities are fulfilled

 

Overall Clinical Pharmacology TMF-Tasks (50%):

  • Review TMF documents for completeness, accuracy, and quality within required timelines while maintaining consistency and attention to details
  • Plan and perform periodic quality checks on the TMF documents to ensure completeness, consistency, and compliance; and to identify any filing issues to ensure that the TMF meets quality standards
  • Escalate issues to the clinical study team that may impact the TMF quality Communicate all systematic filing and recurring issues to manager for further training evaluation
  • Ensure audit/inspection readiness of the CP clinical study documentation
  • Support the clinical study teams in the preparation, conduct, and follow up of internal and/or external audits/inspections, including regulatory agency inspections
  • Oversee the quality of the work done by the persons involved in the documentation-related tasks

 

Candidate’s Requirements

 

  • University degree in science or health-related discipline and/or degree in Nursing
  • Minimum 2-3 years clinical research experience in a Contract Research Organization (CRO) or Pharmaceutical Company with experience in monitoring on-site clinical trials (phase I experience would be a plus), and with experience in management of clinical documents and Trial Master Files (TMFs)
  • Strong knowledge of ICH-GCP guidelines and other applicable regulatory requirements and guidelines
  • Strong understanding of all roles and responsibilities of relevant functions involved in clinical studies
  • 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
  • Excellent oral and written communication skills in English; any other language is advantageous
  • Willing and able to travel as required in different countries (travel time up to 30-40%)
  • Quality-conscious (e.g., understands the impact of missing or incorrect documents in the TMF on regulatory submissions, audits, and inspections)

 

What Idorsia offers

 

  • Exciting opportunities  for development and professional growth within our dynamic organization
  • A collaborative and solution oriented enviroment 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: 1255

 

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.

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