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Regulatory & Site Services Specialist
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REGULATORY & SITE SERVICES SPECIALIST
Regulatory & Site Services Specialist Wilmington or Cary office, NC; King of Prussia office, PA; or Bristol office, TN.
This is an office based position with the options of working from home 2 days/week.
Expert in regulatory, project startup and/or related maintenance activities for a particular country or region. Responsible for leading or executing the majority of regulatory, startup and/or maintenance activities on projects, within the project timelines and in line with the RSS budget. Specific responsibilities for a particular individual, project or region may be adaptable to accommodate individual experience and interest, department needs, and regional requirements across the RSS spectrum to include leading and performing regulatory and ethics submissions, participating in study feasibility to support conduct of a trial, and collecting or approving essential documents. The RSS specialist progresses from performing study work to leading RSS projects including, project oversight of other RSS team members.
DUTIES & RESPONSIBILITIES
Accountabilities / Responsibilities
1. Support the feasibility and site selection process on designated studies with support from senior team members.
2. Liaise with all other departments to ensure the smooth running of the study including preparation of deliverables in accordance with client expectations, ICH/GCP, SOPs and Work Instructions (WIs), budget, quality and applicable laws and guidelines.
3. Serve as the primary contact with competent authorities (CAs), ethics committees (ECs) and/or investigative sites throughout the study.
4. Work with investigative sites to collect the required investigator and regulatory documents for a study.
5. Collate documents required for site activation in accordance with the country specific checklist and in the required timelines.
6. Ensure that Chiltern s tracking and project management systems are kept up to date regarding study actions, milestones, and dates.
7. Maintain accurate, timely knowledge of the directives, regulations and guidelines relating to ethics and clinical trial applications in assigned countries. Maintain awareness of any country specific and any applicable multi-country requirements and regulations (e.g. European Commission s Eudralex Volume 10 for countries within the European Economic Area) as required to perform assignments.
8. Assist with preparation of Clinical Trial Applications (CTAs) packages including initial submission, amendments and End of Trial Declarations as well as submission of notifications and status reports to the CA and IRB/IECs and to any other applicable country-specific authority/body, in assigned countries (except FDA).
9. Liaise with RSS Project Lead/Manager regarding preparation of responses to questions from CAs and IRB/IECs, for assigned countries. Assist with submission of responses to CA and IRB/IECs and to any other country-specific authority/body after Regulatory Project Lead/Manager approval.
10. With guidance from line manager and experienced colleagues, adapt Informed Consent Forms, labels and other patient facing material to country specific requirements.
11. Review translations of study documentation in accordance with the translation plan and/or relevant SOPs/WIs (e.g. ICFs, patient facing material, correspondence with authorities etc.).
12. Provide project administrative support to RSS project lead and/or department as required.
13. Perform other duties as required by the Department.
Education & Experience
* Bachelor s degree in life science, Biomedical or nursing degree
* Minimum 0 2 + years of experience, or an equivalent combination of education and experience to successfully perform the responsibilities of the job
* Experience of the clinical research process and terminology
* Experience using a clinical trial management system
* Some experience in regulatory and study start-up.
Skills and Attributes
* Ability to maintain confidentiality of employee data and information related discipline or experience in the role.
* Good computer literacy with working knowledge of PCs, Windows and Microsoft Office applications
* Ability to communicate effectively in English, as well as the national languages of applicable countries
* Understanding of the principles of ICH GCP and regulatory requirements.
Chiltern is committed to providing equal employment opportunities. In the US, Chiltern is an EEO / AA Employer and is committed to providing opportunities to minorities, women, individuals with disabilities, and candidates with military service.
Please note: applications that do not meet the criteria stated above may not receive a response.
Chiltern is an EEO / AA Employer and is committed to providing opportunities to minorities, women, individuals with disabilities and veterans.
Email Maria Meneses