Clinical Research Associate
Company: Arrowhead Pharmaceuticals, Inc
Location: Pasadena
Posted on: March 20, 2023
Job Description:
The PositionThe Clinical Research Associate (CRA) provides
support to the Clinical Operations Manager (COM)/Study Lead(s) to
manage and track key study deliverables. The primary purpose of the
position is to support the COM/Study Lead to ensure study
deliverables are met and compliance with clinical protocols, their
objectives and ICH and GCP guidelines.Responsibilities
- Support Study Lead to execute study milestones against study
timelines
- Tracking of key deliverables during start-up, study maintenance
and close-out; generate, review and distribute reports from
internal tracking at requested intervals (Site Status, Enrollment,
Dosing)
- Support the Study Lead and contribute to development/review of
certain study-specific plans and/or processes
- Collect and review essential documents from investigational
sites
- Support CTAs with TMF set-up, maintenance, ongoing quality eTMF
reviews, and final reconciliation of study documents
- Support Study lead in study specific tasks such as investigator
identification and site activation
- Contribute to the development/review of study specific
Monitoring Plans; track timing/planning of site visits to ensure
compliance
- Contribute to the development/review of study materials, case
report forms (CRFs), informed consent documents for clinical
studies
- Perform first round review of monitoring visit reports
- Assist in the preparation and review of site reference
materials (i.e., screening/enrollment logs, Delegation of Site
Responsibilities form, Site Monitoring Log, etc.)
- Support Study Lead to arrange and prepare for Site
Qualification Visits, Site Initiation Visits and Site Investigator
Meetings (as applicable)
- Provide updates on study/site status as needed to ensure timely
study entry and updates are reflected on ClinicalTrials.gov or EU
equivalent
- Assist Study Lead with design and preparation of study related
materials for the training of CRO staff
- Assist Study Lead with oversight of study vendors (CRO, Drug
Supply, Central Lab) as required
- Support Study Lead with data reviews as needed to assist
CDM
- Assist clinical finance and study lead with the review,
tracking and management of study specific budgetsRequirements:
- Minimum of five (5) years in clinical research
- Minimum of three (2) years site management experience
- Experience managing/supervising vendors
- Thorough understanding of all applicable FDA ICH- GCP
regulations and guidelines
- Working knowledge of medical terminology
- Ability to proactively perform and complete duties with minimal
supervision in an accurate and timely manner
- Proficient in MS Office (Word, Excel, and PowerPoint)
- Ability to work in a team or independently
- Effective interpersonal, written and verbal communication
skills
- Able to critically evaluate job tasks and the impact on overall
study execution
- Strong problem-solving capabilities
- Effectively collaborates with Study Team members
- Exceptional organizational skills with the ability to
multi-task and prioritize
- Attention to detail
- Ability to work with distributed team members and outside
vendors
- Occasional travel in US or overseas (Preferred:
- 4-year college degree
- CRA certification
Keywords: Arrowhead Pharmaceuticals, Inc, Pasadena , Clinical Research Associate, Healthcare , Pasadena, California
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