Senior Clinical Project Assistant
- Employer
- Pharmacyclics, LLC
- Location
- Sunnyvale, CA
- Posted
- Jun 23, 2018
- Ref
- 2432
- Discipline
- Clinical, Clinical Research
- Hotbed
- Biotech Bay
- Required Education
- Bachelors Degree
- Position Type
- Contract
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/
Senior Clinical Project AssistantGeneral Position Summary/Purpose:
The Senior Clinical Trial Assistant (Sr CTA) [1] 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 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
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
BA/BS or equivalent degree in a scientific discipline, RN, or related field is preferred but not required
1-3 years 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
Working knowledge of regulatory documents and TMF maintenance
Acts as primary point of contact for vendors, investigational sites and cross functional teams and escalates to the study lead as necessary
Supports and occasionally leads the development/review of clinical study plans, presentations or project/study-related documents including contracts/site payments Supports in the development and design of CRFs, including participating in the EDC and IXRS specification process and UAT
Responsible for oversight and mentoring of junior team members
Performs and may lead in-house review of clinical data listings for completeness and accuracy and escalate issues to the CTM or above 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
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 (contractors, CRO, internal)
Assists with providing oversight of CROs, , independent CRA and vendors including managing cross-functional teams
Reviews monitoring trip reports and track resolution of all action items
May participate in site visits as needed or accompany junior team members for training purposes
Collaborates with internal cross functional teams (i.e., Clinical Science, Biometrics, Regulatory Affairs, etc.), to ensure effective delivery of the assigned project milestones
Organizes and manages internal team meetings, investigator meetings, and other trial specific meetings as required
Provides support to the CTM in the development and management of vendor scope of work (SOW) per contract, quality, budget, and detailed timelines including investigator and vendor payments
Maintains completion of required corporate training on standards, policies, work instructions by due date
Performs other work-related duties as assigned
Knowledgeable of clinical research operations, including interpretation and implementation of FDA regulations/ICH/GCP guidelines, is required
Ability to work on complex or multiple projects and exercise critical thinking with minimal supervision
Solid attention to detail and excellent organization skills
Solid interpersonal skills and communication skills (both written and oral)
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
Proficient with Sharepoint with filing systems is desirable
BA/BS or equivalent degree in a scientific discipline or related healthcare field is preferred but is not required
Minimum of 5 years of clinical trial experience in a pharmaceutical, biotechnology, CRO and/or healthcare setting (including 2+ years on-site monitoring experience)
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 oncology preferred
Experience in global trials preferred