Humera - Administrative and Professional Staffing

CLINICAL RESEARCH SPECIALIST

7 days left

Location
St. Louis Park, MN, United States
Salary
Contact For Rate
Posted
Nov 16, 2017
Closes
Nov 26, 2017
Job Type
Employee
Employment Status
Full Time
Humera 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:
  • 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

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

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