Senior / SSU Specialist
Proclinical is looking for and experienced Clinical Study-start up specialist . In this role you are responsible for conducting and facilitating specific start up activities that may include site identification, feasibility and document review. This is a Homebase role working from anywhere in Germany.
- Review and negotiate site regulatory documents and contracts with sites for agreement on wording and budgets. This will be done with consultation from the regulatory lead and contracts lead regionally.
- Maintain and manage SSU data tracking entries in database. Review for completeness and accuracy.
- Review and provide feedback to SSU manager on site performance metrics.
- Work with regulatory team members and SSU manager to secure authorization of regulatory documents.
- Responsible for the collection and maintenance of the current Regulatory/Competent Authority (CA) and Ethics Committee (EC) submission information, and similar information for other related organizations, for the assigned country.
- Responsible for the translation and co-ordination of translations for documents required for submission.
- Responsible for liaising with local CRA/CTM, Contract Specialist, and Regulatory Lead to enable a rapid clinical trial start up.
- Work with legal team members and SSU Manager to secure authorization of contracts.
- Inform team members of completion of regulatory and contractual documents for individual sites.
- May participate in feasibility and/or site identification activities.
- Attend project meetings with cross functional department leads to provide strategy for identifying potential investigators.
- Collects and reviews initial regulatory packets and site contracts for investigator sites.
- Maintains current knowledge of relevant country regulations, and GCP and ICH Guidelines for clinical research.
- Create, review and customization of country/site specific Informed Consent Forms (ICFs).
- Facilitates process improvement efforts both within the department and in cooperation with other departments.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.