Site Activation Specialist
vor 2 Wochen
**Requisition Number**7729**
**Employment Type**:Regular**
**Who we are**
Worldwide Clinical Trials (Worldwide), a leading global contract research organization (CRO), works in partnership with biotechnology and pharmaceutical companies to create customized solutions that advance new medications - from discovery to reality. Anchored in our company’s scientific heritage, our dedicated therapeutic focus on cardiovascular, metabolic, neuroscience, oncology, and rare diseases, is applied to develop flexible plans and solve problems quickly for our customers.
Our talented team of 3,000+ professionals spans 60+ countries. We are united in cause with our customers to improve the lives of patients through new and innovative therapies.
**Why Worldwide**
We believe everyone plays an important role in making a world of difference for patients and their caregivers. From our hands-on, accessible leaders, to our cohesive and supportive teams, we are committed to enabling professionals from all backgrounds and experiences to succeed. We prioritize cultivating a diverse and inclusive environment that continues to promote collaboration and creativity. We are proud to be a workplace where people thrive by being themselves and are inspired to do their best work every day. Join us
**What Site Activation does at Worldwide Clinical Trials**
Site Activation is the perfect place to develop and further your career. We emphasize the development of project management and strategic planning skills that will advance you through the opportunities within Site Activation or serve as an excellent pathway to advancement in Project Management or other Clinical Operations groups.
**What you will do**
- Track study-specific site regulatory documents by site and/or country and follow up with sites or internal team members as needed
- Support the adaptation of country/site-specific informed consent forms
- 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 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
**What you will bring to the role**
- Strong written and verbal communication skills to clearly and concisely present information
- Ability to adjusts to a changing environment; to prioritize and adapt between detailed and strategic activities while maintaining delivery timelines and quality
- Strong understanding of country level cultural norms and local healthcare systems;
- Ability to initiate and develop relationships with local investigators and key site personnel
**Your background**
- 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, and experience in site activation or regulatory-related function
- Good knowledge of ICH GCP, EU Clinical Trials Directive and other relevant clinical research conduct guidance
- Fluent in German and English language
We love knowing that someone is going to have a better life because of the work we do.
LI-LF1
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