Clinical Research Associate
Clinical Research Associate I
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.
Education & Qualifications
- 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
- 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.
- 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 tool
- Experience with Sharepoint with filing systems is desirable
- Medical, Dental, and Vision Insurance
- 401K Plan with Company Match
- Life and AD&D Insurance