Description
The Regulatory & Start Up (RSU) Specialist 1 performs 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.
Essential Functions:
- 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.
- 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 Degree in life sciences (concluded).
- +1 years of clinical research experience and study start up management experience.
- Fluent English: written and oral communication skills.
- Good analytical and critical thinking skills and the ability to evaluate complex issues from multiple perspectives.
- Good interpersonal skills with the ability to build trust and communicate with clarity, flexibility and adaptability to changing requirements.
- Demonstration of successful execution, preferably in start up, and aptitude for managing multiple priorities in a fast‐paced environment.