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Clinical Trial Assistant


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Title:Clinical Trial Assistant
Duration:12 Months
Location:Irvine, CA, 92618
Job Id:7375


Bachelor's degree is a must. Ideal candidate is a recent graduate interested in clinical research. This person is detailed oriented and very flexible as the department can easily shift directions and the person will need to adapt.

Position Summary
the Clinical Research Coordinator II has the responsibility for performing all Clinical Systems and Business related activities to ensure the proper conduct of clinical research trials and clinical affairs activities. The Clinical Research Coordinator III works closely with the Clinical Affairs leadership team, the Director of Clinical Affairs and each clinical research team as well as the Information Systems and Finance departments to ensure that all departmental activities related to the Clinical Trial Management, financial systems, contracts and clinical affairs budgets are compliant, operate within scope and meet the departmental needs.
The CLINICAL RESEARCH COORDINATOR IIs scope of work includes activities such as planning, conduct, creation, tracking, maintenance and closing of the following:
Standard Operating Procedures (SOPs)
Vendor and investigative site contracts
Project and trial review process
CTMS and document management processes
Financial systems and business processes
The CLINICAL RESEARCH COORDINATOR II must perform the following:
Work with the Clinical Affairs team to ensure that the necessary education, training and QC initiatives are provided for Clinical Systems and Business related activities
Participate in departmental contract and finance processes, resources and vendors to ensure full compliance with all laws, regulations, guidance, policies and SOPs that govern the generation and handling of clinical research
Principal Accountabilities
Overall Clinical Systems responsibilities
Participate in the planning, development, implementation, maintenance and update of all required clinical affairs business systems while facilitating the adoption of all necessary processes and tools.
Perform CTMS administrative duties, including reviews, revisions and updates of all CTMS processes, while ensuring operational functionality and compliance with CRF 21 Part 11 and all other applicable laws, regulations, policies, guidance and SOPs.
Develop, implement, review and update SOPs to reflect actual clinical affairs practices
Partner with IT Department to develop and implement all CTMS automations and integration into Company environment
Develop performance metrics and compare to industry standards; facilitate the identification of gaps and potential solutions
Overall Clinical Business responsibilities
Perform all clinical business related activities associated with the development and execution of Master Service Agreements, clinical trial and research contracts and change orders between ev3/ Company and vendors as well as vendors and subcontractors. Audit financial records to ensure required documents are accurately maintained and up to date.
Facilitating the management of all clinical projects and studies budgeting system as well as ensuring proper tracking, maintenance, circulation and filing of all clinical research budget reports
Oversee and facilitate the clinical business processes to enhance the ability to efficiently plan and execute all departmental purchase orders, invoices and payments through Companys and vendors respective systems.
Ensure centralized management and record keeping of all third party contracts; maintain an electronic log of executed agreements.
Plan, conduct and document the budgeting cycle activities.
Coordinate the information and processes necessary to develop RFPs for projects to be outsourced.
Interface with Company legal, HCC and all other internal organizations necessary to execute contracts in a timely and compliant manner
Develop performance metrics to compare to industry standards and identify gaps and potential solutions.
Communicate with participating clinical Investigators, institutions and vendors conducting clinical research on behalf of Company to expeditiously resolve any outstanding contract and or budget issues.
Communication management responsibilities
Participate in Clinical Systems and Business activities participants, staff and vendors, in achieving all activities required to conduct successful QC/QA Audits and Education Programs
General responsibilities
Actively participate in team meetings related to assigned projects and trials, as well as function and role.
Perform (when appropriate) some of the clinical research administrative tasks associated with Clinical Operations
Interact with Director of Clinical Affairs, Clinical Operations Leadership Team and staff as well as Company Legal, Patents, IT, Finance and R&D (i.e. Project Managers) counterparts to ensure consistency with policy and procedures as well as applicable laws and regulations
Requirements

Bachelor's Degree: Science/ Psychology / Business major, minor or other major in combination with clinical research experience
Experience: 2+ yrs
Other Required Skills:
Must have wide subject matter expertise in clinical systems and business management
Preferred Qualifications:
Prefer that person has worked in a clinical research environment and is knowledgeable about associated regulations and laws.


Contact Person: Manju

If you are interested in this position then you can reach me at 2015249600 X 7944

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