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Sr. Clinical Research Specialist

Lake Zurich, Illinois

Post Date: 07/25/2017 Job ID: 1480 Job Category: Clinical: Clinical Operations and Development

We currently have an opportunity for a Sr. Clinical Research Specialist for our client responsible for project management, implementation and completion of in-house Donor Room and external activities related to all aspects of medical device clinical trials. The candidate will be working independently and will need to be strong in research. They will be responsible for protocol development, CRF design and working with data management to get the proper database aligned with the study as well.

Job Responsibilities:
  • Conduct clinical research throughout all stages of in-house Donor Room and external trials, including design, implementation, monitoring and closeout. 
  • Site initiation including review of trial requirements, GCP, GDP, AE/SAE with site staff and investigator and assists in identifying and performing initial qualifications visits of potential sites.
  • Manage start-up activities, continual monitoring at sites, tracking subject recruitment and enrollment, site issues and reporting of specific trial issues to ensure compliance with regulations and study protocol and mediate all issues with site personnel.
  • Generate monitoring reports: site initiation, monitoring and close out reports as well as final reports per SOPs.
  • Conducts laboratory assessments as required.
  • Serve as the primary contact with in-house investigators and staff for assigned trials. 
  • Develop clinical trial protocols, informed consents, investigator brochure as applicable and training materials.
  • Prepare Excel spreadsheets as database for collection and storage of study trial data and ensure spreadsheets are verified and incorporate appropriate edits for internal trials.
  • Assist site with data collection tools.
  • Obtain required clinical inventory approvals per SOP. Ensure all investigational materials (drug and device) are available, distributed, documented and reconciled accurately.
  • Negotiate budgets and contracts related to each project including clinical sites and contract laboratories).
  • Reporting status of clinical trials and research projects to management.
  • Ensure compliance with the trial protocol and regulations.
  • Work with Statistics to review statistical analysis plans and draft algorithms required for assigned projects.
  • Work with data management to design, review, edit, electronic CRFs for the electronic data capture (EDC) system and draft tables/listings/figures. Ensure all required data for final report are collected.
  • Review of Advertising and Promotion materials for assigned products.

Qualifications/ Requirements:
  • Bachelor’ s degree required; Advanced scientific degree preferred
  • 3-4 years of clinical monitoring experience in a pharmaceutical, biotech or medical device industry preferred (Blood experience a plus)
  • Proven scientific and technical writing; clinical protocols and study summaries
  • Knowledge and understanding of:
  • FDA 21CFR, ICH Guidelines, HIPPA, other applicable local regulations.
  • Good Documentation Practices, Good Clinical Practice.
  • Excellent verbal and written communication, interpersonal and organizational skills; proven track record of management of long-term professional relationships (e.g. clinical sites)
  • Meticulous attention to detail.
  • Proficient with Microsoft Office (Word, Excel, PowerPoint, Adobe Acrobat Professional)
  • Prior experience with industry standard paper and electronic clinical data management systems.
  • Proven team player
  • Ability to travel 30-40% of time

Aaron Goldman
Clinical Recruiter

Aaron is a spirited guy who likes to make things happen. He has been a Clinical Recruiter for the past five years, and says his greatest reward comes when a candidate accepts an offer and he hears the excitement in their voice - You know you have helped someone change their life!
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