Clinical Trials Assistant/Senior Clinical Trials Assistant

Position Summary

The Clinical Trials Assistant (CTA) / Senior Clinical Trials Assistant (Sr. CTA) is accountable for all clinical document management and TMF oversight and reconciliation responsibilities, accountable for clinical trial disclosure management according to regulations, tracking and supporting GCP Inspection readiness activities for AnaptysBio-sponsored studies through Clinical Development. The CTA/Sr. CTA will also support the investigational product greenlight process, when required. The CTA/Sr. CTA will support the clinical study managers and directors of clinical operations on study management activities, as required. They will also support cross-functional teams ensuring effective and efficient conduct of clinical research studies by providing administrative and project tracking support, as assigned. The CTA/Sr. CTA will also support in tracking and oversight of clinical contracts, invoices, and budget management, as required. 

Essential Functions:

• Supports Trial Master File (TMF) set-up, maintenance, ongoing quality review, and final reconciliation of study documents;   Provides oversight of TMF vendor, serves as TMF subject matter expert and assists team members requesting access to the TMF
• Sets up, organizes, and maintains clinical study documentation such that it is audit ready and available for final reconciliation and archival 
• Assists with the production and/or review of study-related Clinical Operations guidance documents (e.g., Trial Master File   Maintenance Plans, Monitoring Plans, etc.)
• Participates in essential documents and regulatory package review as part of study oversight team
• Executes meeting logistics (e.g., schedule meetings, distribute meeting agendas and minutes, tracks attendance), as needed 
• Triage Clinical Operations central email accounts; Maintains internal database of investigators and team trackers
• Works with Clinical Study Manager(s) on updates needed to clinicaltrials.gov and other clinical trial registrations, as required
• Communicates trends and helps to prepare updates to senior management on status of study conduct. Informs the study   manager/project team of progress of projects and tasks for which he/she has designated responsibility
• Assists with the production of project/protocol slides, presentations, and study-related reports, etc., as needed for project, departmental, sponsor and/or business development presentations
• Assists with tracking of safety report distributions
• Updates relevant Clinical Operations tracking systems with trial progress, if applicable. 
• Performs document tracking and signature/approval follow-up, where applicable, including Confidential Disclosure Agreements   (CDAs), contracts, proposals, invoices, and other study documentation 
• May provide vendor oversight of program level vendors and be accountable for managing vendor scope of work, finalizing   contracts and reviewing invoices
• May perform initial review of invoices against contracted services and assist with budget management
• May contribute to SOP development, reviews and departmental process improvement efforts

Education and Experience:

• BA or BS in scientific/healthcare or life sciences field, or BSN
• CTA: 1 year of clinical support experience or equivalent combination of education, training and experience
• Sr. CTA: 2 years of clinical support experience or equivalent combination of education, training and experience

Knowledge and Competencies:

• Understanding of ICH GCP, regulations, relevant SOPs and internal tracking systems. 
• TMF management
• Good organizational skills, ability to multi-task and meticulous attention to detail. 
• Ability to work in a cross-functional team or independently, as required.
• Able to develop and maintain good working relationships with investigators, staff and vendors
• Effective interpersonal skills.
• Flexible and adaptable team member who takes initiative in a frequently changing clinical environment
• Good written and verbal communication skills. 
• Ability to maintain confidentiality of proprietary information
• Proficient in Microsoft Word, Excel, PowerPoint, Outlook.  

All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.