CRQ Specialist – Job Description July 6, 2016
General Purpose
To assist with Clinical, Regulatory and Quality projects and to complete specific projects while ensuring consistency with quality standards, commitments and goals.
Essential Functions and Responsibilities
• Plan and implement projects, meetings and events (define scope, goals, and deliverables)
• Ensure project teams prioritize and complete work on schedule and up to standard
• Take minutes and su mmarize information for reports
• Develop PowerPoint presentations for online and inperson training
• Complete data entry and checking/verifying accuracy of data
• Develop and write draft documents (e.g. Clinical Evaluation Reports per Med Dev 2.7.1; Technical
File sections per international regulations; 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
• Track project deliverables using appropriate tools
• 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 sciencerelated field or equivalent work experience
• At least 3 years clinical, regulatory and/or quality work experience
• Demonstrates ability to multitask, prioritize and ensure reliability
• Experience and qualification in project management
• Proven experience in people management
• Excellent organizational skills and timemanagement 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 and Frestedt Inc. staff
Requirements:
• Must be 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
Contact info@frestedt.com to apply.