Clinical Trial Assistant
Pharmacyclics is committed to the development and commercialization of novel therapies intended to improve the quality and duration of life and to resolve serious unmet medical needs for cancer patients. Pharmacyclics is a wholly-owned subsidiary of AbbVie (NYSE:ABBV), a global, research-based biopharmaceutical company. Oncology is a key therapeutic area for AbbVie, with a portfolio consisting of three marketed products and a pipeline containing multiple promising new molecules that are being studied in more than 200 clinical trials for over 20 different types of cancer.
More than 1,200 Pharmacyclics and AbbVie research scientists, clinicians, marketing, operations and corporate professionals work in the San Francisco Bay Area. They combine their expertise in immuno-oncology, stem cells, and cell-signaling with their knowledge of bispecific antibodies, antibody-drug conjugates (ADCs), and covalent-inhibitor technologies to discover and develop novel cancer treatments. Together, we are striving to outsmart cancer.
General Position Summary/Purpose:
The Clinical Trial Assistant provides support to the clinical study teams in the execution of clinical trials. Primary responsibilities include maintaining Trial Master File (TMF) and Clinical Trial Management System (CTMS) in an inspection-ready state, assisting with site management, initiating collection, reviewing and tracking of essential documents throughout the life of the trial. Contributes to the production and distribution of study materials and site/study communications.
Key Accountabilities/Core Job Responsibilities:
Study Planning and Conduct:
· Establishes and maintains the TMF and CTMS. With minimal supervision of the CRA, CTM or Study Lead, the CTA/Sr. CTA will review the CTMS/TMF for compliance, addressing findings as needed and supporting the study team with study activities · Assists clinical operation leads in the development, handling, distribution, filing and archiving of essential documents in the TMF · Assists and/or contributes to the creation and maintenance of study materials for clinical studies, including but not limited to site and CRA training material, regulatory document templates, study binders, study plans, study communications and presentations · Handles incoming and outgoing clinical trial related materials shipments to site, study team, CRAs and vendors, as needed · Assists with all aspects of initial study drug release including regulatory packet review and study-drug release · Assists clinical study team with the planning, preparation, and on-site support of investigators meetings. · Assists in the development of case report forms and participate in the EDC and IXRS specification process, as appropriate · Communicates directly with sites, Site Management Organizations (SMOs), Contract Research Organizations (CROs) and field CRAs to obtain updated information, essential documents, etc. to assist with driving start-up, study conduct, and/or close out activities · Ensures timely study entry and updates to ‘Clinicaltrial.gov' and maintains until end-of-study under supervision · Assists with tracking of clinical trial progress including status updates reports, as requested · Assists with final sign off of project and study-related documents including: informed consent forms, monitoring plans, synopses, protocols and amendments, and other documents, as required · Participates in clinical teams, including attending required meeting, and interacts in a positive, professional manner. May coordinates meetings/teleconference/WebEx. Prepares agendas, minutes and tracks action items. · Maintains completion of required corporate training on standards, policies, work instructions by due date · Identifies and escalates issues appropriately · Performs other work-related duties as assigned
Qualifications:· Understanding in relevant clinical operations activities · Ability to exercise judgment within generally defined practices and policies that lead to methods or processes for obtaining results under supervision · Basic knowledge and understanding of ICH/GCP guidelines and FDA regulations required · Working knowledge of TMF maintenance and management of essential documents · Solid interpersonal, written and verbal communication skills across study team including study management · Computer skills including proficiency in the use of Microsoft Word, Excel, Powerpoint, and organization tools · Experience in Sharepoint with filing systems is desirable · Attention to detail and accuracy in work · Effective time management and organization skills · Ability to multi-task under limited direction and on own initiative · Performs other work-related duties as assigned
Education and Experience:· BA/BS or equivalent degree in a scientific discipline, RN, or related field is preferred but not required · 1-3 years of experience in the pharmaceutical, biotechnology, CRO and/or healthcare setting · Demonstrate basic understanding of medical terminology and clinical activities in relation to execution of Clinical Development Plan · Consideration for Sr. title will be based on previous experience and/or education