Changing lives. Building Careers. Joining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, our colleagues are challenging what's possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care. Collaborates internally and externally with departments and sites regarding specific study related activities or processes as listed below including, but not limited to: Feasibility assessments: develop study material e.g. questionnaires/slide sets with CRM support), distribute to sites, provide analysis, etc.). Liaises with Legal to secure confidentiality agreements, master service agreements, clinical trial agreements as appropriate. Participates in the review and development of CRFs, CRF guidelines, and database. Provides quality overview and consistency checks on all developed ICFs and completes the informed consent checklist. Responsible for the completion and approval of regulatory green light forms for site activation. Responsible to provide step by step guidance and partnership with sites to secure IRB approval (local and central). Accountable to maintain the electronic Trial Master Files (TMF) by performing ongoing reviews to assure quality of the documentation files and compliance with SOPs, GCP and ICH Guidelines. Acts as the primary approver of all regulatory documents and is accountable for developing and reviewing regulatory documentation to support study start up activities. This includes the completion of the Greenlight Forms for site activation and ensuring all site supplies and IP are available on site for site initiation visits. Performs in‐house review of CRF data for completeness and accuracy and resolves data management/query issues with study sites and vendors as needed. Interacts with other functional areas and key stakeholders, including Medical Affairs, Data Management, Finance, Regulatory, Safety and Clinical vendors (e.g., imaging vendors, CROs), as needed, to support clinical trial activities. Integra LifeSciences is an equal opportunity employer, and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status. This site is governed solely by applicable U.S. laws and governmental regulations. If you'd like more information on your rights under the law, please see the following notices: EEO Is the Law (https://www.eeoc.gov) | EOE including Disability/Protected Veterans (https://www.eeoc.gov/eeoc/publications/ada\_veterans\_employers.cfm) Integra LifeSciences is committed to provide qualified applicants and employees who are disabled veterans or individuals with disabilities with needed reasonable accommodations in accordance with the ADA (https://www.eeoc.gov/eeoc/publications/fs-ada.cfm) . If you have difficulty using our online system due to a disability and need an accommodation, please email us at careers@integralife.com. Integra - Employer Branding from Integra LifeSciences on Vimeo (https://player.vimeo.com/video/265760526)