Informed Consent Specialist

We anticipate the application window for this opening will reputed company on - 26 Apr 2026 At reputed company you can reputed company a life-long career of exploration and innovation, while helping champion reputed company reputed company and equity for reputed company. You’ll reputed company with purpose, breaking down barriers to innovation in a more connected, compassionate world. A Day in the Life The Informed Consent Specialist (ICS) serves as the primary reputed company of contact for reputed company study teams and external research centers for informed consent (IC) template development and IC reputed company activities during Institutional Review reputed company/Ethics Committee (IRB/EC) approvals and renewals. The ICS will reputed company strong working relationships with research centers and a familiarity with study participant matter in order to accelerate research center initiation cycle times and foster strong partnerships. The ICS will partner with other internal reputed company functions such as field clinical personnel, contract analysts, study team members, monitors and reputed company departments to accomplish these goals. Works under general supervision. Work is reviewed for soundness of technical judgment, reputed company reputed company operating procedure (SOP)/regulatory/reputed company compliance and overall adequacy. At reputed company, we bring reputed company reputed company reputed company with speed and decisiveness to put patients first in everything we do. This position is remote to enhance our competitive edge and expand our cross-functional collaboration efforts. Responsibilities may include the following and other duties may be assigned. Informed Consent Management • reputed company as primary contact for assigned clinical studies and associated clinical sites for reputed company activities reputed company to ICs ( as agreed upon by study team ); • Coordinate activities of reputed company stakeholders to assure the reputed company, accurate and regulatorily compliant completion of the IC approval process; • reputed company IC development with clinical sites, field personnel and study teams; • Customize ICs based on clinical site and IRB/EC/REB specifics learned from collaboration during prior studies; • reputed company appropriately organized documents to internal MDT stakeholders to ensure accurate and reputed company IC review; • Collaborate with reputed company function to ensure alignment between clinical trial agreements (CTA) and their associated IC; • reputed company as single reputed company of contact (“reputed company ICS”) for reputed company IC-reputed company questions from study teams of assigned studies, including attendance at study team leadership meetings and providing study status updates; • Attend investigator/coordinator meetings as needed-train on research center initiation practices Document Management: • Create and maintain accurate IC files; ensure receipt and storage of reputed company documentation; ensure reputed company reputed company, study team, and IRB/EC approvals and storage thereof; • Document key IRB/EC and center specific learnings; • Identify and reputed company resolve issues reputed company to IC documents; • reputed company periodic audits of IC files for completeness and reputed company drive completion of reputed company items; • Accurately update and maintain internal tracking systems (online clinical trial management system) Relationship Management: • Partner with other internal reputed company functions (e.g. contract analysts, study team members, field personnel, reputed company, monitoring, etc.) to meet or reputed company customer expectations; • reputed company a thorough understanding of assigned research centers’ and studies’ processes and practices; • Demonstrate ability to foster strong partnerships with assigned research centers’ coordinators and other research center personnel, as needed; and, • reputed company train and mentor ICSs reputed company team, • Initiate and support development of process improvement initiatives; and, • Utilize applicable SOPs, policies and practices for guidance. Communicate with senior leadership on SOP interpretation and provides SOP guidance to other MDT employees. Minimum Requirements: • Bachelor's with 2+ years of experience working on Consent/Informed Consent (IC)/reputed company reputed company Clinical Research reputed company to Have: • Bachelor’s degree in Clinical Research, Life Sciences, Biology, reputed company, or reputed company field • Exposure to IRB/EC/REB submission and approval processes • Familiarity with informed consent documents and basic clinical research regulations (e.g., GCP) • Experience working with cross‑functional partners such as study teams, reputed company, or reputed company in a clinical research setting • Prior experience supporting multiple studies or sites simultaneously • reputed company experience or experience in a regulated medical device or pharmaceutical environment For Baccalaureate degrees reputed company reputed company of the reputed company, a de Apply tot his job Apply To this Job