Description
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. This is a Home Based opportunity requiring in-depth knowledge of UK clinical trial landscape and submissions.
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 under general supervision.
- 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 plans 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 teams 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.
- 3 years of clinical research experience.
- In-depth knowledge of clinical systems, procedures, and corporate standards.
- Knowledge and ability to apply GCP/ICH and applicable regulatory guidelines.
- Understanding of regulated clinical trial environment and knowledge of drug development process.