Senior Clinical Research Associate
Vir Biotechnology (Vir), a San Francisco based company focused on infectious disease, is seeking an experienced Senior Clinical Research Associate. You will be responsible for assisting with clinical trial management, site management, data review, and the planning and development of study start-up, execution, and oversight while ensuring the study is conducted in compliance with the protocol, ICH/GCP, applicable regulatory requirements and SOPs.
- Acts as primary point of contact for vendors, investigational sites and cross functional teams and escalates to the study lead as necessary.
- Supports and may lead the development and review of clinical study plans, presentations or study-related documents.
- Supports in the development and design of CRFs, including participating in the EDC and IWRS specification process and UAT.
- Assists with set-up of central labs and study vendors as required, including liaising with study management CRO to ensure site training and timely initiation.
- Performs in-house review of clinical data listings for completeness and accuracy and escalate issues to the study manager, as needed.
- Manages clinical monitoring activities and the overall site management ensuring compliance with Good Clinical Practices (GCP) and applicable regulations and tracking of site performance metrics.
- May perform accompanied site visits with CRO CRAs to ensure correct study procedures according to SOPs and protocol procedures, and review of routine regulatory documents/files in compliance with protocol, regulatory requirements, SOPs, and study plans, as required.
- Reviews monitoring trip reports and track resolution of all action items.
- Responsible for the development and distribution of study newsletters, tracking and reporting of recruitment updates.
- Participates in the selection, training, and evaluation of study personnel (vendor, CRO, internal).
- Assists with providing oversight of CROs and vendors including managing cross-functional teams.
- Responsible for oversight and mentoring of junior team members.
- Collaborates with internal cross functional teams to ensure effective delivery of the assigned project milestones.
- Organizes and manages internal team meetings, investigator meetings, and other trial specific meetings, as applicable.
- Provides support in the development and management of vendor scope of work (SOW) per contract, quality, budget, and detailed timelines including investigator and vendor payments, as applicable.
QUALIFICATIONS AND EXPERIENCE:
- 4+ years of experience with knowledge of clinical research operations, including interpretation and implementation of FDA and EMEA regulations, ICH/GCP guidelines.
- Ability to work on complex or multiple projects and exercise critical thinking with minimal supervision.
- Relevant clinical trial experience in the pharmaceutical or health care industry or equivalent.
- Demonstrates core understanding of medical terminology or clinical trial activities
- Experience in interactions with outside vendors, e.g., CROs and other vendors is preferred.
- Experience in global trials preferred.
- Excellent verbal, written, interpersonal and presentation skills are required.
- Ability to establish priorities, excellent sense of urgency and collaborate (interpersonal, relationship management) with the study team, cross functional team members and external partners/vendors.
- Demonstrates problem solving skills.
- Demonstrates leadership skills, self-motivated and adaptable to a dynamic environment
- Computer skills including proficiency in the use of Microsoft Word, Excel, PowerPoint, and organization tools.
- BA/BS or equivalent degree in a scientific discipline or related healthcare field.