Pharmacyclics, LLC

Clinical Project Assistant

Location
Sunnyvale, CA, United States
Posted
Mar 29, 2019
Ref
2722
Hotbed
Biotech Bay
Required Education
Associate Degree
Position Type
Full time
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.

To learn more about us, please visit us at http://www.pharmacyclics.com/

General Position Summary/Purpose:

The Clinical Project Assistant (CPA) provides support to the clinical study teams in the execution of clinical trials. Under the direction of the Clinical Project Associate, CTM or Study Lead, the CPA's 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 of and reviewing and tracking essential documents throughout the life of the trial. This role contributes to the production and distribution of study materials and site/study communications.

Key Accountabilities/Core Job Responsibilities:

Study Planning and Conduct:

  • 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
  • Facilitates site vendor setup, debarment checks, and CDA and site agreement submissions
  • 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 and maintenance of 'Clinicaltrial.gov' and until end-of-study under supervision
  • Conduct study tracking support (eg, CTMS tracking, start-up tracking, milestone tracking, close-out tracking) and study updates, as requested
  • Assists with final sign off of project and study-related documents including: informed consent forms, monitoring plans, synopsis, protocols and amendments, and other documents, as required
  • Participates in clinical team activities, including attending required meetings, and interacts in a positive, professional manner. May coordinate meetings/teleconference/WebEx, prepares agendas, minutes, and tracks action items
  • Ensures required corporate training on standard operating procedures, policies, work instructions are completed by the 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
  • Demonstrates understanding of existing process, SOPs, work instructions (WI)
  • Solid interpersonal, written and oral communication in a clear, timely, practical manner; actively listens to team members and business partners, asking questions, as appropriate, to confirm understanding and avoid miscommunications
  • Demonstrates an understanding of what assigned tasks are on critical path and uses this knowledge to guide time management and prioritization
  • Demonstrates ability and willingness to actively participate and contribute to group efforts
  • Computer skills including proficiency in the use of Microsoft Word, Excel, PowerPoint, and organization tools
  • SharePoint and filing systems experience is desirable


Education and Experience:

  • 1+ years experience in the pharmaceutical, biotechnology, CRO and/or healthcare setting. Education in lieu of experience will be considered (ie, BS in Clinical Research Management).
  • BA/BS or equivalent degree in a scientific discipline, RN, or related field is preferred
  • Basic understanding of medical terminology and clinical activities in relation to execution of Clinical Development Plan


Equal Opportunity Employer Minorities/Women/Veterans/Disabled