As Inhouse CRA, you participate in the planning and conduct of our client’s clinical studies. You exercise independent judgment in planning, organizing, and performing work; you monitor performance and reports status to manager. You ensure compliance to study protocol, domestic and international Good Clinical Practices, applicable regulatory standards, and our client’s Standard Operating Procedures. You are able to solve complex problems; You consider alternative or new perspectives using existing tools and standard processes. Your primary focus is on providing support of site management activities.
- You ensure regulatory and clinical protocol compliance for all assigned clinical projects.
- You review informed consent document to ensure all required elements are included.
- You provide product/protocol specific support and training to internal and external clinical personnel.
- In partnership with our client’s assigned field staff and in-house personnel, you coordinate the start-up and maintenance of the clinical study site.
- You coordinate and lead activities with study specific committees, vendor services, and core labs.
- You conduct the follow-up and resolution of findings from monitoring visits and audits.
- You independently review site compliance and raise issues to study management.
- You serve as a liaison to field clinical and site personnel by responding to any protocol-related issues and escalating as appropriate.
- You communicate and collaborate with all levels of employees, customers, contractors, and vendors.
- You apply general clinical research processes and regulatory knowledge to actively improve processes and efficiencies.
- You mentor less experienced clinical team members.
- You contribute to global process improvements and provides input to departmental Standard Operating Procedures (SOPs) and Departmental Work Instruction (DWIs).
- You identify and routinely use the most effective, cost efficient and best business practices to execute processes; continually evaluats effectiveness and appropriateness.
- You manage small projects and process improvement efforts that are critical to help support departmental goals and objectives.
- You have a University degree with a first experience in clinical trials (mandatory)
- You have strong written and verbal communication in English, interpersonal, presentation, analytical, organizational, technical writing, and problem solving skills.
- You are able to meet deadlines and work effectively with all levels of employees.
- You are proficient in Microsoft Office Suite and relevant clinical applications.
- You have the ability to work independently when necessary.