Senior Clinical Research Associate

Summary of Position:

This position has responsibility for strategic and operational leadership relating to the direction, planning and execution of all monitoring activities associated with clinical trials ensuring the highest quality. The successful candidate will provide day to day oversight of cross-study monitoring activities, data quality, 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.

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Job Title:  Senior Clinical Research Associate

Reports to:  VP, Clinical Operations

Employment Type:  Full-Time

FLSA Status:  Exempt

Date:  Winter, 2020

Required Skills & Abilities:

  • Detail oriented and accurate, excellent communication skills both written and spoken.
  • Ability to work collaboratively with team members
  • Ability to work across numerous studies proactively identifying potential issues and managing relationships with CRO monitoring teams, supporting clinical sites, vendors and internal teams
  • Together with Management and Quality the individual implements a monitoring strategy to ensure compliance with all applicable regulatory requirements and makes recommendations to regarding the specific activities and resources required to support this strategy
  • Able to influence, negotiate, problem solve
  • Ability to write reports, procedural manuals and business correspondence
  • Able to serve as a resource to study leads, safety, data management and investigators
  • Able to provide guidance developing a comprehensive clinical research monitoring support infrastructure
  • Ability to effectively train and present information
  • Strong organizational skills able to fully outline tasks and bring clinical site activities to closure
  • Able to setup, maintain and audit Trial Master Files
  • Communicates status and escalates ongoing issues to ensure timely decision-making
  • Provides study-level hands-on direction and support as it relates to study conduct and timelines
  • 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
  • Experience directly monitoring oncology trials required
  • Motivated to learn or advance own expertise and value
  • Takes ownership

Qualifications:

  • 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 12 years of clinical monitoring experience is required
  • A minimum of 6 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
  • Experience in all phases of clinical trials

Benefits:

  • Medical, Dental, Vision, 401(k)

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.

Please send resumes and cover letters to info@aravive.com