Clinical Research Associate I
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: Under direct supervision, the CRA I position begins gaining experience in clinical trial management procedures by assisting in the planning, designing, implementation of Pharmacyclics clinical trial protocols. Will interface with internal and external stakeholders, eg., study coordinators and investigators working with confidential patient and company data and may be directly involved in onsite monitoring, based on business need. In collaboration with senior level staff, participates in data quality review. Develops a basic understanding of the disease, molecule, and indication specific to the clinical trial. Maintains high level of professionalism within Pharmacyclics and external stakeholders. Key Accountabilities/Core Job Responsibilities:
May conduct site visits (pre-study, initiation, interim and close-out ) or serve as a PCYC liaison to resolve site-related issues quickly and efficiently thus ensuring protocol compliance, accurate and thorough data collection, and appropriate study conduct
Participates in review of CRF guidelines and develops understanding of ongoing clinical data review
Develops basic skill in performing manual in-house review of CRF data for completeness and accuracy, and resolving data management and data query issues with study sites and vendors
Develops basic knowledge of the process used to evaluate and select potential investigators and sites
May write monitoring visit reports per SOPs, as needed
Interacts with sites and vendors through communication (written and verbal) and maintains effective management of study issues
Develops basic knowledge in the review process of site's informed consents against the consent template for presence of GCP requirements and protocol specific information.
May assist in the review of informed consent for accuracy Proficient in coordination and review of regulatory documents from study sites to ensure completeness, accuracy, and compliance at the site and in the Trial Master File (TMF)
Supports CRAs in tracking IND Safety Reports for assigned sites
May initiate investigational product shipments and ensures that supplies are adequate for assigned studies and sites
Develops basic knowledge of the investigator contract, budget, and payment process
May prepare site payment tracking for management review
Communicates status of trial to manager and team
Appropriately represents functional area and clinical trial management role
Partners with team members and other functional areas within Pharmacyclics such as Regulatory, QA, Legal, and Biometrics
Maintains completion of required corporate training on standards, policies, work instructions by due date
Perform other work-related duties as assigned
Good verbal and written communication skills and attention to detail and organizational skills are necessary
Basic knowledge of ICH/GCP and FDA regulations
Working knowledge of TMF/CTMS maintenance and management of essential documents
Ability to multi-task under limited direction and on own initiative
Computer skills including proficiency in the use of Microsoft Word, Excel, Powerpoint, and organization tools
Experience with Sharepoint with filing systems is desirable
BA/BS or equivalent degree in a scientific discipline, RN, or healthcare related field is preferred but is not required.
1+ years of CRA experience in an industry setting, or two years of pharmaceutical/health care field experience.
Demonstrate understanding of medical terminology or clinical activities.