Department: Medical Organization/Clinical Team

Job Title: Senior Clinical Research Associate, Clinical Operations

Description:

The Senior Clinical Research Associate, Clinical Operations will coordinate the activities associated with the evaluation, initiation, management, and close-out of clinical trials within the Clinical Development department.  This position will also work with the Clinical Operations team to identify clinical infrastructure gaps and develop systems and processes for addressing the gaps.  The Senior CRA role provides an outstanding opportunity to work in a matrix environment and collaborate with colleagues in clinical data management, biostatistics, regulatory, safety, and early development.
 

Clinical Study Management
·         Identify, select, and monitor investigational sites for clinical studies
·         Ensure studies are carried out according to study protocol, SOPs, and ICH/GCP regulations
·         Track progress of study including patient enrollment, monitoring visits
·         Investigate queries, monitor discrepancies
·         Manage the site conduct, and the investigational product accountability and reconciliation process
·         Manage the budget and payments for investigative sites and contract organizations
·         Design and administer Case Report Forms
·         Write or contribute to preparation of clinical protocols, amendments, consent forms, study guides, CRFs, and any other clinical research related document
·         Develop queries for data analysis
·         Negotiation and finalization of investigator budgets
·         Review of data listings and summary tables, including query generation
·         Oversee performance of CROs and field CRAs to ensure compliance with study protocol
·         Co-monitor sites with field CRAs
·         Train CRAs on protocols and practices consistent with Onyx and GCP standards
·         Assist in identification and hiring of appropriate CROs and study vendors
·         Generation and/or review of relevant sections of clinical study reports, IND annual reports, and Investigator Brochures
·         Requires up to  40% travel

Departmental Infrastructure
·         Collaborate with CRAs and Directors to identify Clinical Operations process needs
·         Work with manager to identify/develop processes and procedures for enhancing department efficiency
·         Develop plans for implementation of departmental infrastructure enhancements
·         Conduct SOP gap analysis and oversee preparation of new or modified Clinical Operation SOPs

Job Requirements:

EDUCATION:
·         Bachelor’s degree in a scientific discipline or equivalent
·         Thorough knowledge of GCP/ICH guidelines including an understanding of regulatory requirements
·         Thorough knowledge of monitoring procedures
EXPERIENCE:
·         Minimum 5 years directly related experience overseeing multiple concurrent trials
·         Must have demonstrated knowledge of concepts and practices for clinical trial conduct
·         Must be well versed in FDA regulations and GCP
·         Ability to work independently and exercise good judgment in planning and accomplishing goals
·         Strong oral and written communication skills, along with good organizational and planning skills are a must.
·         Ability to deal with time demands, incomplete information or unexpected events and work effectively in a team/matrix environment.
·         Advanced computer skills, experience with administration of site budgets and grants with supervision and experience with reviewing adequacy of site-proposed informed consents for compliance with relevant regulations. 
·         Oncology experience preferable

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