Responsible for supporting Site Activation and Regulatory (SAR) activation and maintenance activities with emphasis on the quality and delivery of the Essential Document Packet. Responsibilities include Essential Document collection, tracking, review and provision of country/site requirements to support achievement of site activation goals and ongoing maintenance activities in compliance with Good Clinical Practices (GCPs) and applicable local and international regulations and Standard Operating Procedures (SOPs).Conducts and supports site level feasibility assessments by coordinating site identification at a country and regional level. This includes supporting site qualification, site start-up activities pertaining to Regulatory Authorities submissions under the direction of the Regulatory Affairs team; and liaison with sites to support contracts/budget negotiations under the direction of the Site Contracts team. RESPONSIBILITIES:
Track study-specific site regulatory documents by site and/or country and follows up with sites or internal team members as needed and reports to the SAR Lead
Support the development and adaptation of country/site specific informed consent forms
Maintain regular communication with sites to ensure timely completion of start-up and maintenance activities
Interface with relevant functional leads to ensure appropriate prioritization of essential document collection and review to facilitate synchronized start-up
Collect, receive, and perform first review of required study-specific site regulatory/essential in accordance with applicable SOPs, guidelines and relevant study specific plans. Implement corrective action as needed, prior to essential document review sign off and follow up on Non-Hold items post sign off (where applicable)
Where applicable, provide local follow up and updates of status of local EC submissions to the Regulatory Affairs and relevant teams assigned to the project
Where required, complete, manage and/or support country and site-specific activities (e.g., compiling, submitting and obtaining import/export licenses, radiation board and biobank committee approvals, etc.) required to activate sites for a clinical trial as appropriate
May perform pre-award feasibility studies
Support Site Identification activities including the negotiation and collection of Confidential Disclosure Agreements and the collection and analysis of Site Identification Questionnaires
Support the collection of country and site level intelligence
Support the development of a preliminary potential site list
May conduct remote pre-study site visits (where applicable and allowed by sponsor)
Support translations according to governing SOPs
May help train SAR colleagues to foster quality delivery throughout the SAR department
May support regulatory activities under guidance as needed for critical delivery or for professional self-development if desired
Be familiar with and comply with SOPs, ICH GCP and applicable regulations
Maintain an understanding of FDA and/ or EU Directives and regulations, ICH Guidelines and country/local regulatory requirements.
OTHER SKILLS AND ABILITIES:
Organizational and time management skills
Aptitude for planning, strategizing, managing, monitoring, scheduling, and critiquing skills
Self-motivated learning about current regulatory processes and intelligence accompanied by knowledge sharing and training within and beyond the SAR department team
Strong written and verbal communication skills to clearly and concisely present information
Easily adjusts to a changing environment; ability to prioritize adapt between detailed and strategic activities while maintaining delivery timelines and quality
Strong ability to handle multiple tasks in a fast-paced and changing environment
Proficiency in MS-Office applications including Microsoft Word, Excel, and PowerPoint
Aptitude for contemporary digital systems is helpful
Team-oriented work style; seeks and gives guidance to others
Strong understanding of country level cultural norms and local healthcare systems; ability to initiate and develop relationships with local investigators and key site personnel
Strong understanding of clinical research principles and process
REQUIREMENTS:
A minimum four-year college curriculum with a major concentration in medical, biological, physical, health, pharmacy or other related science
Minimum one year of experience in clinical research, preferably in site activation or regulatory-related function
Previous experience within the pharmaceutical/CRO industry
Good knowledge of ICH GCP, EU Clinical Trials Directive and other relevant clinical research conduct guidance
Multilingualism preferred; fluent in local language; working knowledge of English
Crée en 1978 par Jean AYMAR
Présent en 8 pays
+ 10 0000 Colaborateurs
20 M de CA
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Le Lorem Ipsum est simplement du faux texte employé dans la composition et la mise en page avant impression. Le Lorem Ipsum est le faux texte standard de l'imprimerie depuis les années 1500, quand un imprimeur anonyme assembla ensemble des morceaux de texte pour réaliser un livre spécimen de polices de texte. Il n'a pas fait que survivre cinq siècles, mais s'est aussi adapté à la bureautique informatique, sans que son contenu n'en soit modifié. Il a été popularisé dans les années 1960 grâce à la vente de feuilles Letraset contenant des passages du Lorem Ipsum, et, plus récemment, par son inclusion dans des applications de mise en page de texte, comme Aldus PageMaker.
