Job Description

A highly reputable pharmaceutical corporation is currently hiring a qualified Clinical Operations Associate to work in the greater Irvine, CA. area.

JOB SUMMARY :

• The Clinical Operations Associate will be responsible for execution of assigned clinical operations activities in support of study conduct throughout the study life cycle and will ensure quality execution and compliance with all required policies and procedures in completion of assigned tasks.
• This individual will work closely with clinical operations management to ensure adherence to applicable metrics associated with assigned tasks completion.

 ESSENTIAL JOB FUNCTIONS :

• Responsible for clinical operations aspects of clinical trials conduct as assigned including but not limited to:(e)Trial Master File and essential documents management.
• Contracts processing and execution
• Facilitation of Investigator and study registration updates
• Facilitate development and QC of Informed Consent and other study specific documents
• Development of processes and controlled documents
• Facilitate Clinical Document Change Request activities
• Manage HCP/HCO clinical engagement activities per policies and procedures
• Responsible for facilitating clinical Risk Assessment and Quality Management System (QMS) activities (e.g. deviations and CAPAs) including management of activities within the QMS platform.
• Manage and/or support clinical audit activities as assigned
• Participate in the development, review, implementation and updating of key standard processes that lead to positive and measurable impact for clinical programs managed by the clinical research team (e.g. quality, efficiency, consistency)
• Lead management of clinical systems updates, enhancements and master data stewardship as required
• Manage coordination of activities across clinical teams for the completion and continued execution of process improvement and compliance related initiatives as assigned.
• Responsible for tracking and reporting of Key Performance Indicators (KPIs) and metrics for quality oversight of applicable clinical operations related activities as assigned
• Collaborate/Interact with internal and external stakeholders as related to conduct of required job responsibilities
• Additional activities may be assigned as appropriate

 EDUCATION/QUALIFICATIONS

• Bachelors Degree or equivalent in a scientific or health care field preferred 
• Two (2) years of related experience preferred
• Experienced with PC-Windows, word processing, and electronic spreadsheets required
• Knowledge of ICH/GCP, local regulatory authority drug research and development regulations and clinical trial operations required
• Clinical trials support or pharmaceutical industry experience required
• Demonstrated strengths in planning, organizational, analytical skills, oral and written communication, time management, conflict management, problem solving, and attention to detail
• Excellent written and verbal communication skills and strong interpersonal skills necessary to interface with team members, outside vendors, and consultants
• Comfortable in a fast-paced environment and able to adjust workload based on changing priorities
• Ability to work effectively within a team matrix as well as independently
• Ability to collaborate and respond to changing circumstances and needs
• Ability to travel as required to carry out responsibilities
• Proficient in Microsoft products (Outlook, Word, Excel, PowerPoint)
• The manager can train but hoping to have at least eTMF and document management experience.

Company Description

Beacon Hill Pharma, Beacon Hill Staffing Group's Pharma specialty division, is a national staffing organization that provides contract, direct (permanent), FSP/outsourcing and consulting to pharmaceutical, medical device, biotech and contract research organizations. Beacon Hill Pharma places contractors in all 50 states by seamlessly coordinating recruiting resources in local and regional markets with Beacon Hill Pharmas National Recruiting & Delivery, a dedicated national recruiting team that focuses exclusively on national accounts, supporting regional recruiting operations and delivering contractors to all markets in the U.S. Whether start-ups or the Fortune 500, the public or private sector, Beacon Hill Pharma matches world class talent with exceptional opportunities.