Beschreibung
Site Activation Specialist (f/m/d) - CRA / ICH/English / clinical trial / GermanProject:
For our customer Roche Diagnostics International AG based in Rotkreuz we are looking for a highly qualified Site Activation Specialist
Background:
The Site Activation Specialist is responsible for site start-up activities for the assigned studies within the Site Alliance and Site Activation Sub-Chapter under Clinical Operations. The position will require strong stakeholder management working closely with Contracting, Legal, Privacy, Study Teams, CRO, and Sites.
Tasks & Responsibilities:
* Responsible for the effective operations and delivery of site activation deliverables across all regions, within the assigned projects
* Supports the pre-study site identification/selection process for relevant studies through collection and analysis of site feasibility information
* Maintain regular communications with investigational sites/CRO to ensure timely completion of the required site activation activities/documentation and resolve or escalate issues in a timely manner
* Collect, receive and perform the first review of required study-specific site regulatory/essential documents in accordance with applicable SOPs, guidelines, and study timelines and requirements
* Coordinate Investigator Review Board (IRB)/Ethics Committee (EC)/other relevant regulatory submissions in collaboration with sites/study teams
* Work with sites to ensure informed consent form meets the required regulatory and company requirements
* Facilitate the translation of essential documents that may be required in languages other than English for the purposes of submission to and approval from Competent Authorities and/or IRB/EC
* Coordinate the clinical trial insurance process to ensure timely results and support throughout the conduct of the clinical study
* Support contract and budget negotiations in partnership with Contracting and Study Teams
* Ensure Purchase orders and Fair Market Value assessments are completed for timely start-start up
* Support study instrument placements, Obtain import/export licensure
* Support implementation and use of eTools at the site
* Collect and maintain relevant country, local, state, and site-level regulatory intelligence for future use
* Work closely with Study Teams to deliver study start-up tasks
* Solve identified issues with appropriate timely escalation to the Study Teams
* Support internal audit and external inspection activities; contribute to CAPAs as required.
Must Haves:
* Bachelor's or Master's (no PhD) degree in chemistry, biology, other life sciences, or a related field, or equivalent combination of education and experience
* Experience in study start-up is required or experience as CRA or within clinical research / trial
* Experience in clinical trial planning, including IRB/Ethics Committee, Competent authority submissions and contracts
Knowledge of clinical trial methodologies, medical terminology, ICH/GCP
* Must be fluent in English, German is a plus
* Understand the quality expectations and emphasis on the right first time, attention to detail
* Ability to organize tasks, time, and priorities, ability to multitask
* Required to support multi-national team members, and flexibility in working hours may be needed
* Ability to participate and work effectively with multiple cross-functional teams
* Ability to work in an ambiguous environment and great communication skills
Nice to Have:
* Experience with CRO management is a plus
* Working knowledge of global and local regulatory requirements (IVDR and other applicable regulations) is a plus
* Additional European language are a plus
Reference Nr.: 923153SGR
Role: Site Activation Specialist
Industrie:Pharma
Workplace:Rotkreuz
Pensum: 100%
Start: 18.01.2024
Duration: 12++
Deadline: 10.01.2024
If you are interested in this position, please send us your complete dossier via the link in this advertisement. If this position does not fit your profile and you wish to be considered for another position directly, you can also send us your dossier via this ad or to jobs[at]itcag[dot]com.
Contact us for more information about our company, our positions or our attractive Payroll-Only programme: .
About us:
ITech Consult is an ISO 9001:2015 certified Swiss company with offices in Germany and Ireland. ITech Consult specialises in the placement of highly qualified candidates for recruitment in the fields of IT, Life Science & Engineering.
We offer staff leasing & payroll services. For our candidates this is free of charge, also for Payroll we do not charge you any additional fees.