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Site Regulatory Submissions and Contracts Associate

  • Location:

    Paris, Île-de-France

  • Contact:

    Amandine Planche

  • Job type:

    Contract

  • Contact phone:

    +32 10 68 53 30

  • Industry:

    Medical Device & Diagnostics

  • Contact email:

    amandine_planche@oxfordcorp.com

For one of our client, an international sponsor located in the north of Paris, we are looking for an experienced "Site Regulatory Submission & Contracts Associate", available for a 1 year project (100% office-based position).

Job Description

Support regulatory activities at study start up in France. Focus is preparation of documents for submission to Ethics Committees (EC) and Competent Authorities (CA), especially country and site-specific Patient Informed Consent adaptation; obtain documents required for submission and support the process until vote or approval is granted. EC/CA communication in close collaboration with CSL/CRA/Project Manager.

Responsible and accountable for preparation, negotiation and signature of clinical contracts (including budgets) and amendments in France.

Responsibilities

  • Prepare documents for Ethics Committee/Competent Authority (EC/CA) submission in the assigned region.
  • Initiate translation of documents as applicable (e.g. Patient Informed Consent); review and adapt translations to appropriate verbiage.
  • Prepare Country/Site Specific Patient Informed Consent form according to Regulatory and EC requirements and obtain internal approval where applicable.
  • Interpret clinical study protocols in order to support EC/CA submission where layman terms are required
  • Point of contact of EC /CA
  • Support approval process (adaptation of documents according to EC/CA requirements; responses ….)
  • Support budget adoption to country and site requirements.
  • Prepare submission to any other authority when applicable
  • Maintain local regulatory documents on paper or electronically as applicable and ensure upload to data management system (DMS) were applicable.
  • Provide support to CSL / Clinical Project Teams
  • Assist in the development and review of informed consent document/patient information sheet to ensure all required elements are included.
  • Assist with collection of site activation documents.
  • Adapt study site budget template to country and site-specific requirements
  • Create, prepare, review and edit contracts, new work orders, amendments, modifications and change orders of a medium complexity level and contract risk type.
  • Analyzes document to determine corporate risk; prepares and provides alternative approaches to mitigate the risk.
  • In compliance with Company policies, applicable regulations, Client Legal Department, negotiate with research sites.
  • Work with Legal and other stakeholders (Compliance, Clinical Quality) on contract language such as indemnification, subject injury language, intellectual property rights, confidentiality, compensation, and other similar matters.
  • Negotiate directly with research sites and ensure that the clinical trial budgets are in accordance with the clinical protocol requirements and associated Client policies.
  • Review and approve country/site specific change of the Patient Informed Consents concerning Injury, Data Privacy and Compensation language involving specialists from other departments as needed

Do the above responsibilities fit you like a glove?
Download your CV and motivation letter via the "apply now" button and you can expect feedback from us soon.
If something is not entirely clear, you can reach out to us by telephone off course.


Requirements

  • Demonstrated experience with clinical regulatory and contracting activities (for minimum 2 years)
  • Bachelor's degree from an accredited university or college or relevant experience in clinical research or related device/pharmaceutical experience or relevant clinical experience in a clinical/hospital environment.
  • Proficient in operating a personal computer and in using various PC-based software packages including Microsoft Word, Excel, or similar word processing/spreadsheet software.
  • Experience with databases is desired.
  • French - Native Speaker; The ability to read, write, and communicate effectively in French is required; this requirement includes clear, understandable speech, demonstrated comprehension skills, and demonstrated competence in French spelling, grammar and punctuation and the ability to effectively correspond with laymen as well as EC/CA representatives.
  • The ability to read, write, and communicate effectively in English is also required.
  • A general familiarity with cardiac, vascular, and/or neuromodulation technologies, and clinical research processes is desired, along with related experience in a medical device/pharmaceutical company or relevant clinical experience in a clinical/hospital environment.
  • A general familiarity with French regulations is desired, especially familiarity with Data Protection and Radiation protection.

Benefits

  • A full time position for a 1 year project
  • Competitive salary with extra legal benefits

Existing right to work in Europe required ( please read job spec in full before applying ).

Vacancy Number: 16145