Clinical Site Activation Specialist
m/f/d, Zug
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.
Contract duration: 1 year
Hybrid: 2 - 3 days on-site
Workload: 100%
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.
Requirements
- Associate or Bachelor’s 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
- 1-3 years experience in clinical trial planning, including IRB/Ethics Committee, Competent authority submissions and contracts
- Knowledge of clinical trial methodologies, medical terminology, ICH/GCP
- Working knowledge of global and local regulatory requirements (IVDR and other applicable regulations)
- Required to support multi-national team members, and flexibility in working hours may be needed
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