Inginaire - Engineering Staffing

CLINICAL RESEARCH SPECIALIST

7 days left

Location
St. Louis Park, MN
Salary
Contact For Rate
Posted
Nov 16, 2017
Closes
Nov 24, 2017
Ref
815269-03
Job Type
Employee
Employment Status
Full Time
Inginaire is looking for a Clinical Research Specialist for our client in St. Louis Park, MN. Our client is a company that provides support in running clinical trials, testing and implementing quality training sessions. This is a direct hire opportunity.


Essential Functions and Responsibilities
  • Project management including planning, implementation, prioritization, meetings minutes and data entry/analysis on behalf of clients to keep projects on time, high quality and within budgets
  • Develop materials for on-line and in-person training (e.g. PowerPoint presentations)
  • Develop and draft project documents per internal and external SOPs, Work Instructions and Template documents (e.g. Clinical Evaluation Reports per Med Dev 2.7.1; EU/Global Design Dossiers, Technical Files for CE Marking; FDA 510(k)s, PMAs; policies, procedures, forms and templates; clinical trial summaries and reports, abstracts and publications, etc.)
  • Conduct literature searches and draft literature review documents
  • Develop and execute clinical research studies and programs with appropriate staffing
  • As needed, monitor clinical studies
  • As needed, Recruit and schedule subjects for clinical trials and assessments
  • As needed, Work directly with research subjects during study visits
  • Perform essential management functions (scheduling, filing, responding to phone calls, emails and faxes, assisting with accounts payable and receivable)
  • Other duties as assigned

Qualifications:
  • Bachelor’s degree in a medical or science-related field or equivalent work experience
  • At least 3 years clinical, regulatory and/or quality work experience demonstrating ability to multi-task, prioritize and ensure reliability
  • Experience and qualification in project management
  • Advanced exposure to FDA, EU regulations and processes with the ability to read, analyze and implement regulations, standards and guidance documents across multiple industries and disciplines
  • Proven experience in people management
  • Excellent organizational skills and time-management skills
  • Demonstrated ability to execute projects on time and on budget
  • Strong computer skills with advanced levels using Outlook, Word, Excel, PowerPoint, QuickBooks, and other software tools
  • Strong written and oral communication skills
  • Passion for clinical research, regulatory and quality affairs activities for pharmaceutical, medical device and food industries
  • Ability to productively interact with client companies, corporate executives and research sites as well as research subjects
Requirements:
    Qualifications:
    • Bachelor’s degree in a medical or science-related field or equivalent work experience
    • At least 3 years clinical, regulatory and/or quality work experience demonstrating ability to multi-task, prioritize and ensure reliability
    • Experience and qualification in project management
    • Advanced exposure to FDA, EU regulations and processes with the ability to read, analyze and implement regulations, standards and guidance documents across multiple industries and disciplines
    • Proven experience in people management
    • Excellent organizational skills and time-management skills
    • Demonstrated ability to execute projects on time and on budget
    • Strong computer skills with advanced levels using Outlook, Word, Excel, PowerPoint, QuickBooks, and other software tools
    • Strong written and oral communication skills
    • Passion for clinical research, regulatory and quality affairs activities for pharmaceutical, medical device and food industries
    • Ability to productively interact with client companies, corporate executives and research sites as well as research subjects
    Requirements:
    • Must have CER writing experience
    • Must be focused, efficient, detail oriented and able to work independently
    • Able to travel to client sites as needed (less than 20% travel; mostly in TC area)
    • Must have excellent critical thinking and problem solving skills
    • Able to coordinate training sessions and to secure the required training documentation
    • Able to reprioritize immediately as new projects arrive
    • Experience and qualification in project management
    • Advanced exposure to FDA, EU regulations and processes with the ability to read, analyze and implement regulations, standards and guidance documents across multiple industries and disciplines
  • Must be focused, efficient, detail oriented and able to work independently
  • Able to travel to client sites as needed (less than 20% travel; mostly in TC area)
  • Must have excellent critical thinking and problem solving skills
  • Able to coordinate training sessions and to secure the required training documentation
  • Able to reprioritize immediately as new projects arrive
  • Experience and qualification in project management
  • Advanced exposure to FDA, EU regulations and processes with the ability to read, analyze and implement regulations, standards and guidance documents across multiple industries and disciplines

Schedule:
SHIFT: 1ST SHIFT, 8AM TO 5PM WITH AN HOUR OFF FOR LUNCH

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