Clinical Trial Specialist

Title: Informed Consent Specialist (ICS) Location: RemoteDuration: 24 MonthsPayrate: $40-$45/hr on W2Responsibilities:Act as primary contact for assigned clinical studies and associated clinical sites for all activities related to ICs;Coordinate activities of internal and external stakeholders to assure the timely, accurate and regulatorily compliant completion of the IC approval process;Lead 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;Provide appropriately organized documents to internal MDT stakeholders to ensure accurate and timely IC review;Collaborate with Contracts function to ensure alignment between clinical trial agreements (CTA) and their associated IC;Act as single point of contact (“Lead ICS”) for all IC-related 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 proper documentation; ensure proper legal, study team, and IRB/EC approvals and storage thereof;Document key IRB/EC and center specific learnings;Identify and actively resolve issues related to IC documents;Perform periodic audits of IC files for completeness and actively drive completion of action items;Accurately update and maintain internal tracking systems (online clinical trial management system);Relationship Management:Partner with other internal functions (e.g. contract analysts, study team members, field personnel, legal, monitoring, etc.) to meet or exceed customer expectations;Develop 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,Actively train and mentor ICSs within 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.Must Have (Minimum Requirements):To be considered for this role, the minimum requirements must be evident on your resume.Bachelor’s degree, ideally in Clinical Research, Biology or Chemistry, and a minimum of 2 years of experience working on consent/Informed Consent (IC)/contracts within clinical research, or advanced degree in Clinical Research, Biology or Chemistry with 0 years of experience.Nice to Have (Preferred Qualifications):3-5 years clinical study administration or related experience;Juris Doctor/law degree or advanced degree in Clinical Administration;Bilingual (or more);Demonstrated expertise in medical or technical area;Complete understanding of clinical processes, regulations and regulatory standards; and,Proficiency with regulatory and compliance guidelines for clinical trials