You serve as the SPOC for studies, ensuring compliance and quality in startup activities, while managing document workflows and project timelines.
Anforderungen
- •Bachelor’s Degree in life sciences
- •3 years’ clinical research experience
- •In-depth knowledge of clinical systems
- •Knowledge of GCP/ICH guidelines
- •Knowledge of local regulatory requirements
- •Understanding of clinical trial environment
Deine Aufgaben
- •Serve as Single Point of Contact (SPOC) for assigned studies
- •Ensure adherence to standard operating procedures and quality standards
- •Perform startup and site activation activities according to regulations
- •Distribute completed documents to project teams and sites
- •Prepare and review site regulatory documents for accuracy
- •Maintain internal systems and databases with project information
- •Review and provide feedback on site performance metrics
- •Establish and monitor project planning and timelines
- •Inform team of completed regulatory and contractual documents
- •Track and follow up on document approvals and releases
- •Provide local expertise during project planning
- •Perform quality control of documents from sites
- •May contact sponsors on specific initiatives
Original Beschreibung
# Regulatory and Start Up Specialist 2 Germany (m/w/d) Home Based
**Frankfurt, Hesse, Germany** | **Full time**
**Job Overview**
Perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. May also include maintenance activities.
**Home Based role requiring German language fluency.**
**Essential Functions**
* Under general supervision, serve as Single Point of Contact (SPOC) in assigned studies for investigative sites, Site Activation Manager (SAM), Project Management team, and other departments as necessary.
* Ensure adherence to standard operating procedures (SOPs), Work Instructions (WIs), quality of designated deliverables and project timelines.
* Perform start up and site activation activities according to applicable regulations, SOPs and work instructions.
* Distribute completed documents to sites and internal project team members.
* Prepare site regulatory documents, reviewing for completeness and accuracy.
* Ensure accurate completion and maintenance of internal systems, databases and tracking tools with project specific information.
* Review and provide feedback to management on site performance metrics.
* Review, establish and agree on project planning and project timelines. Ensure monitoring measures are in place and implement contingency plan as needed.
* Inform team members of completion of regulatory and contractual documents for individual sites.
* Review, track and follow up the progress, the approval and execution of documents, regulatory, ethics, Informed Consent Form (ICF), and Investigator Pack (IP) release documents, in line with project timelines.
* Provide local expertise to SAMs and project team during initial and on-going project timeline planning.
* Perform quality control of documents provided by sites.
* May have direct contact with sponsors on specific initiatives.
**Qualifications**
**Bachelor’s Degree in life sciences or a related field and 3 years’ clinical research experience**.
* In-depth knowledge of clinical systems, procedures, and corporate standards.
* Knowledge and ability to apply GCP/ICH and applicable regulatory guidelines.
* Knowledge of applicable regulatory requirements, including local regulations, SOPs and company’s Corporate Standards.
* Understanding of regulated clinical trial environment and knowledge of drug development process.