Arrowhead Pharmaceuticals, Inc. San Diego , CA 92140
Posted 2 weeks ago
The Position
The Sr. Clinical Research Associate (Sr. CRA) provides support to Study Lead(s) in clinical study planning, execution and management. The primary purpose of the position is to support the COM/Study Lead in study set-up, execution, oversight, and closeout activities in compliance with the clinical protocol, regulatory requirements, ICH GCP guidelines and governing policies & procedures.
Responsibilities
Support assigned study teams with TMF set-up, maintenance, ongoing quality control reviews, and final reconciliation of study documents
Routinely monitor TMF inspection readiness for assigned studies
Assist Study Lead in review of invoices for assigned studies
Contribute to development and finalization of Pharmacy Manual and associated forms, templates and processes
Assist study lead with investigational product and ancillary supplies management, accountability and reconciliation activities
Support IRT system set-up, testing, and on time activation including review of specifications, and user manuals.
Collect and/or review Essential Documents from investigational sites
Review site-level ICFs for accuracy and compliance
Lead study specific tasks such as investigator identification, feasibility, and site activation
Review monitoring visit reports for accuracy and completeness
Attend or conduct site selection, initiation interim monitoring visits, close-out visits and co-monitoring oversight visits
Contribute to the development of study-level documents (study templates, manuals, guides, newsletters, case report forms (CRFs), study master informed consent forms, study-level forms and reference materials, etc.)
Assist in the preparation and review of site-level forms and templates (eg screening/enrollment logs, site signature/responsibilities form, site monitoring log, etc.)
Assist in the preparation of training materials and presentations related to study execution
Provide updates on study/site status as needed to ensure timely study entry and updates are reflected on ClinicalTrials.gov or equivalent
Perform periodic data review as requested by the Study Lead
Support Study Lead in preparing materials for study-wide meetings (eg investigator meetings, interim update meetings, data safety committee meetings, etc.)
Prepare and present updates at team meetings as assigned by Study Lead
Coordinate external service provider (e.g. central lab, recruitment, homecare, etc.) set-up and on-time activation (e.g. specifications, user manuals, etc.) as delegated by the Study Lead
Work closely with CRO to plan for execution of study start-up and ongoing study execution activities as assigned by the Study Lead
Provide guidance, mentorship and oversight to more junior Clinical Operations staff members
Identify, and lead process improvement projects within the Clinical Operations department
Recommend modifications to SOPs/work instructions (WIs) when necessary to improve compliance or efficiency
Maintain compliance with assigned procedures, guidelines, study plans and applicable regulatory requirements
Requirements:
Minimum of five (5) years in clinical research and development
Minimum of three (3) years onsite monitoring/site management experience
Experience managing/supervising vendors
Highly proficient knowledge and understanding of ICH-GCP
Strong organizational skills and attention to detail
Excellent site management and monitoring skills
Proficient software skills (Outlook, Word, Excel, Power Point, MS Project)
Proficient in Veeva eTMF and Medidata EDC
Ability to perform key duties in a timely manner and with minimal supervision
Ability to think critically (analyze, extrapolate knowledge and information and problem-solve)
Ability to work effectively independently and in a collaborative team environment
Must be able to work collaboratively and professionally with team members and outside vendors such as CROs
Excellent interpersonal, verbal and written communication skills
Ability to multi-task and prioritize appropriately
Displays high level of professionalism and understands need for confidentiality in all aspects of position
Preferred:
Arrowhead Pharmaceuticals, Inc.