• Conducting site qualification, initiation, monitoring, and close-out visits for clinical trials • Ensuring protocol compliance, data integrity, and patient safety throughout the trial process • Collaborating with investigators and site staff to facilitate smooth study conduct • Performing data review and resolution of queries to maintain high-quality clinical data • Contributing to the preparation and review of study documentation, including protocols and clinical study reports

• Serve as the primary point of contact between investigation sites and the sponsor for early development multi therapeutic clinical trials. • Conduct all types of site visits, including selection, initiation, routine monitoring, and close-out • Ensure site compliance with ICH-GCP, SOPs, and regulations • Maintain up-to-date documentation in CTMS and eTMF systems • Support and track site staff training and maintain compliance records • Monitor patient safety, ensuring timely and accurate AE/SAE/PQC reporting • Support subject recruitment and retention efforts at the site level • Oversee drug accountability and ensure proper storage, return, or destruction • Resolve data queries and drive timely, high-quality data entry • Document site progress and escalate risks or issues to the clinical team • Assist in tracking site budgets and ensuring timely site payments (as applicable) • Collaborate with cross-functional partners including CTAs, LTMs, and CTMs

• Works on assigned studies to ensure that human subject protection is maintained, Good Clinical Practice (GCP), and applicable regulations are followed. • Coordinates and manages clinical site monitoring responsibilities for assigned studies in accordance with contractual agreements, SOPs, and applicable regulatory guidelines. • May conduct on-site and remote site qualification, site initiation, interim, and site close-out monitoring visits. • Serve as primary point of contact for site questions relating to study enrollment, conduct, and close-out issues: liaise with appropriate study team members as needed. • Communicates through verbal and written communication with site investigator and project team overall site performance, trends, deficiencies, and concerns. • Supports study start-up activities such as tracking and performing quality review of study documents, completing, and distributing site activation letters, etc. • Performs study-related training. • Manages the development and maintenance of study documents, processes and systems as assigned. • Ensures quality and completeness of central and site master files. Tracks and maintains required study documents, performs quality control review, manages renewals. • Tracks study site and over all study metrics including but not limited to enrollment, deviations, adverse events, trial master file maintenance. • Attends internal and external meetings as required. • Provides all job-related progress reports and visit documentation as required. • May support safety activities such as narrative writing, managing the CEC/DSMB, etc. • OUS: Prepares and coordinates submissions to regulatory authorities. • May perform other activities as assigned.

Role Description This position will assist in the research and writing of a book that covers multiple academic disciplines, including law, sociology, psychology, and media studies. - Conduct legal research and summarize research; - Reviewing and summarizing court policies and procedures; - Cite-checking duties; assuring that citations are in proper format, drafting parenthetical summaries as needed; - Organizing and coding research findings and other related data; - Creating tables and graphs to present research findings; - Writing reports of research findings. Qualifications - Strong legal research, analytical, and writing skills; - Strong professional etiquette, including timely communication, excellent interpersonal and communication skills, and the ability to work collaboratively. Requirements - Juris Doctor degree; - Experience doing social science research in multiple databases; - Experience writing long-form academic works; - Telecommute within the states of California, Nevada, Oregon, Washington, Arizona, and Illinois. Company Description