The CRA will be responsible for site management and reporting of trials in accordance with company plans/objectives, ICH/GCP, local requirements and company standard operating procedures. Additional responsibilities will include in-house data review and occasionally leading the planning and development of study set-up.
· Acts as primary point of contact for investigative sites and cross functional teams and escalates to the study lead as necessary.
· Assists in the development of study-related documents such as study manuals, monitoring plans, informed consents, recruitment materials and other study related tools.
· Supports in the development and design of CRFs, including participating in the EDC and IWRS specification process and User Acceptance Testing (UAT).
· Performs in-house review of clinical data listings for completeness and accuracy and escalate issues as needed.
· Responsible for the development and distribution of study newsletters and tracking/reporting of recruitment updates.
· May participate in co-monitoring and/or training visits, TMF and on-site audits as requested.
· Participates in the training of investigative sites and third-party vendors.
· Assists with providing oversight of CROs and vendors, including managing cross-functional teams.
· Works to ensure that trials are conducted in adherence to study protocols, applicable SOPs, FDA regulations, ICH/GCP guidelines and local government regulations.
· Assists with the organization and management of internal meetings, investigator
meetings and other trial specific meetings as required.
·Performs other work-related duties as assigned.
BA/BS or higher in a scientific field. Minimum of 2 years of clinical trial experience in a pharmaceutical, biotechnology, CRO and/or healthcare setting.
Job Type: Full-time