Summary of Position:
This position has responsibility for operational leadership relating to the direction, planning and execution of monitoring and data quality activities associated with clinical trials. The successful candidate will provide day to day oversight of monitoring activities, data review and quality, and compliance to study protocols and GCPs for clinical studies being conducted globally. The individual is responsible for planning, coordination, control, and continuous improvement of processes and methods to ensure conformance to internal and external quality standards and directs monitoring and compliance functions associated with study oversight. The individual will provide oversight of contracted monitoring teams and complete co-monitoring visits to ensure oversight, data integrity and determine compliance with IRB approved protocols, standard operating procedures (SOPs), Good Clinical Practice (GCP) and applicable regulatory requirements.
Job Title: Associate Director, Clinical Operations
Reports to: VP, Clinical Operations
Employment Type: Full-Time
Location: Raleigh/Durham, NC
FLSA Status: Exempt
Date: Spring, 2021
Required Skills & Abilities:
- Implement a monitoring strategy to ensure compliance with all applicable regulatory requirements and make recommendations for specific activities and resources required to support this strategy
- Proactively identify potential issues and manage relationships with CRO monitoring teams, support clinical sites, vendors and internal teams
- Monitor the quality of vendor deliverables, address quality issues with the appropriate team member and identify opportunities to improve training, execution and quality control across the clinical team
- Implement a plan for data review and quality assurance in collaboration with CRO and internal clinical and data sciences functions
- Provide efficient updates on trial progress to senior leadership with respect to monitoring and data review activities, CRO oversight, quality standards and risk mitigation.
- Review and approve site visit reports; ensure tracking, follow up and resolution of site issues have been completed in a timely manner.
- Effectively provide support to the CRO monitoring team in the conduct of the trials and serve as a general resource to study leads, safety, data management, and investigators
- Effectively train and present information
- Detail oriented and accurate, excellent communication skills both written and spoken.
- Write reports, procedural manuals and business correspondence
- Understanding of Trial Master File organization and ability to setup, maintain and audit files
- Communicate status and escalate ongoing issues to ensure timely decision-making
- Ability to develop and manage budgets
- Able to support the development of clinical monitoring infrastructure including standard operating procedures (SOPs), working practice documents, vendor oversight standards
- Motivated to learn or advance own expertise and value
- BA/BS in scientific field of study
- Completion of an accredited Nursing (RN), Physician Assistant, or Bachelor’s Degree in related healthcare, preferred and/or extensive clinical research
- SoCRA Certified Clinical Research Professional (CCRP) or ACRP Certified Clinical Research Coordinator (CCRC) required. ACRP Certified Clinical Research Associate (CCRA)-preferred
- A minimum of 10 years of clinical monitoring experience is required
- A minimum of 5 years of oncology study monitoring experience required
- QA, Regulatory, Auditing, Data management experiences a plus
- Trained on numerous EDC systems
- Therapeutic experience in oncology, Ovarian cancer experience preferred
- Phase 3 trial experience preferred
Aravive, Inc. is an Affirmative Action/Equal Opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, protected veteran status, national origin, disability, sexual orientation, gender identity, marital status, genetic information or any other characteristic protected by law.
Company Overview: Aravive, Inc. is developing treatments designed to halt progression of life-threatening diseases, including cancer. Our approach draws on novel insights into targeting signaling pathways that drive the activation, migration and invasion of abnormal cells into healthy tissues. The company is based in Houston, Texas, and received support from the Cancer Prevention & Research Institute of Texas (CPRIT). For more information, please visit our website at https://aravive.wpengine.com.
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