Sr Site Activation Specialist
About The Position
Perform country-level Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements, and contractual and budgetary guidelines. The role may also include maintenance activities. This developing professional individual contributor works under moderate oversight and supervision and recommends enhancements to systems and processes to solve problems or improve effectiveness. Problems are generally not complex but may require understanding a broader set of issues. Under general supervision, the specialist serves as the single point of contact for investigative sites, the Site Activation Manager (SAM), the Project Management team, and other departments on assigned studies. The specialist supports feasibility, site identification, start-up, site activation, and related document processes, while maintaining project systems and tracking tools and helping ensure quality and schedule adherence. The role may include direct sponsor contact for specific initiatives.
Requirements
- Bachelor’s degree in life science or a related field.
- Three years of clinical research or other relevant experience, or an equivalent combination of education, training, and experience.
- Three years of clinical research experience, including one year of experience in a leadership capacity; an equivalent combination of education, training, and experience is accepted.
Responsibilities
- Serve as the single point of contact for investigative sites, the Site Activation Manager, the Project Management team, and other departments on assigned studies.
- Ensure adherence to SOPs and work instructions, the quality of assigned deliverables, and project timelines.
- Perform feasibility, site identification, start-up, and site activation activities in accordance with applicable regulations, SOPs, and work instructions.
- Distribute completed documents to sites and internal project team members.
- Prepare site documents and review them for completeness and accuracy.
- Maintain accurate project information in internal systems, databases, and tracking tools.
- Review site performance metrics and provide feedback to management.
- Review, establish, and agree on project plans and timelines; ensure monitoring measures are in place and implement contingency plans as needed.
- Inform team members when feasibility, site identification, regulatory, and contractual documents are complete for individual sites.
- Review, track, and follow up on the progress, approval, and execution of documents and questionnaires, including CDA/SIF, regulatory and ethics documents, Informed Consent Forms, and Investigator Pack release documents, in line with project timelines.
- Provide local expertise to Site Activation Managers and project teams during initial and ongoing project timeline planning.
- Perform quality control of documents provided by sites.
- May have direct contact with sponsors on specific initiatives.
- Recommend enhancements to systems and processes to solve problems or improve effectiveness.
Benefits
- Health and welfare benefits may be offered, depending on the position.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
