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).
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.
- 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?
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If something is not entirely clear, you can reach out to us by telephone off course.
- 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.
- 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