NSABP Foundation Inc. · 8 hours ago
Clinical Research Associate - Level 3
Pittsburgh, PA
Full-time
Hybrid
Mid Level
3+ years expNSABP Foundation Inc. is seeking a Clinical Research Associate - Level 3 to support breast and colorectal cancer clinical trial operations. This role involves both individual contributions and leadership responsibilities, collaborating across departments and serving as the external face of the organization to partners.
Clinical TrialsHealth CareMedicalNon Profit
Responsibilities
Actively participate in study start-up activities. Examples of frequent activities include participation in partner meetings, study timeline start-up development, site selection, Principal Investigator review
Assist with site activation including document collection, ICF review, site access to study platforms, facilitate site questions
Facilitate team huddles to assess, plan, review and prioritize activities to ensure timely site activation
Participate in study specific training as required
Develop relationships with site staff and NSABP monitors
Act as a liaison among NSABP, site staff, external partners
Track study metrics developed by either NSABP or external partners
Assist with identifying metrics that require additional focus and developing an action plan
Develop and implement recruitment strategies to ensure accrual targets are met
Develop awareness of site visits by monitors. These include site initiation visits, interim monitoring visits, close out visits
Follow Standard Operating Procedures (SOPs), Work Instructions (WIs), GCP and ICH guidelines
Function as a resource for specific Study Start-Up Plans, Clinical Monitoring Plan, Roles and Responsibilities grid and other study-specific documents
Collaborate with clinical research organizations and centralized services such as central laboratories
Collaborate with data management regarding CRF development
Act as a resource to sites and investigators
Perform other job-related duties as assigned
Knowledge of randomized clinical trials principles and procedures
Knowledge of federal and state regulations and guidelines pertaining to the conduct of clinical trials
Knowledge of the infrastructure and operational characteristics of successful patient accrual related to site and study management
Qualification
Required
Bachelor's degree required
Minimum of 3 years' experience as a CRA required
Familiarity with electronic TMF, EDC and CTMS systems required
Strong verbal, written and organizational skills with a team-oriented approach
Ability to handle and prioritize multiple tasks to meet deadlines in a dynamic environment
Proficiency in Microsoft Office Suite
Preferred
Knowledge of randomized clinical trials principles and procedures
Knowledge of federal and state regulations and guidelines pertaining to the conduct of clinical trials
Knowledge of the infrastructure and operational characteristics of successful patient accrual related to site and study management
Company
NSABP Foundation Inc.
Partners in Cancer Research… The NSABP Foundation is a not-for-profit academic research organization with a nearly 60-year history of conducting ground-breaking research studies in breast and colorectal cancer.
51-200 employees
Funding
Current Stage
Growth StageLeadership Team
Ronald A. Sugar, Esq. MBA
Chief Financial Officer
Sheila Evans
Chief Operating Officer
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