Senior Clinical Research Associate

General Position Overview:
The Senior Clinical Research Associate (Sr. CRA) is responsible for assisting with clinical trial management, site management, data review and cleaning, and occasionally leading the planning and development of the study set-up, execution, and may assist with oversight of clinical study while ensuring the trial is conducted in compliance with the protocol, ICH/GCP, applicable regulatory requirements and applicable SOPs/Work Instructions.
Key Accountabilities/Core Job Responsibilities:
Study Planning and Conduct:

• Acts as primary point of contact for vendors, investigational sites and cross functional teams and escalates to the study lead as necessary
• Supports and occasionally leads the development/review of clinical study plans, presentations or project/study-related documents including contracts/site payments Supports in the development and design of CRFs, including participating in the EDC and IXRS specification process and UAT
• Responsible for oversight and mentoring of junior team members
• Performs and may lead in-house review of clinical data listings for completeness and accuracy and escalate issues to the CTM or above as needed
• Manages clinical monitoring activities and the overall site management ensuring compliance with Good Clinical Practices (GCP) and applicable regulations and tracking of site performance metrics
• Responsible for the development and distribution of study newsletters, tracking and reporting of recruitment updates
• Participates in the selection, training, and evaluation of study personnel (contractors, CRO, internal)
• Assists with providing oversight of CROs, , independent CRA and vendors including managing cross-functional teams
• Reviews monitoring trip reports and track resolution of all action items
• May participate in site visits as needed or accompany junior team members for training purposes

Project Management:

• Collaborates with internal cross functional teams (i.e., Clinical Science, Biometrics, Regulatory Affairs, etc.), to ensure effective delivery of the assigned project milestones
• Organizes and manages internal team meetings, investigator meetings, and other trial- specific meetings as required

Financial Planning and Management:

• Provides support to the CTM in the development and management of vendor scope of work (SOW) per contract, quality, budget, and detailed timelines including investigator and vendor payments

General:

• Maintains completion of required corporate training on standards, policies, work instructions by due date
• Performs other work-related duties as assigned

Qualifications:

• Knowledgeable of clinical research operations, including interpretation and implementation of FDA regulations/ICH/GCP guidelines, is required

• Ability to work on complex or multiple projects and exercise critical thinking with minimal supervision
  
• Solid attention to detail and excellent organization skills
  

• Solid interpersonal skills and communication skills (both written and oral)
• Ability to establish priorities, excellent sense of urgency and collaborate (interpersonal, relationship management) with the study team, cross functional team members and external partners/vendors

• Demonstrates problem solving skills Demonstrates leadership skills, self-motivated and adaptable to a dynamic environment

• Computer skills including proficiency in the use of Microsoft Word, Excel, Powerpoint, and organization tools
• Proficient with Sharepoint with filing systems is desirable

Education and Experience Requirements:

• BA/BS or equivalent degree in a scientific discipline or related healthcare field is preferred but is not required
• Minimum of 5 years of clinical trial experience in a pharmaceutical, biotechnology, CRO and/or healthcare setting (including 2+ years on-site monitoring experience)
• Demonstrates core understanding of medical terminology or clinical trial activities

• Experience in interactions with outside vendors, e.g., CROs and other vendors is preferred

• Experience in oncology preferred
  
• Experience in global trials preferred
  

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Equal Opportunity Employer Minorities/Women/Veterans/Disabled