Good Clinical Practice Services
Come apply your expertise in Good Clinical Practice (GCP) and Clinical Quality assurance! Falcon Consulting Group offers specialized consultancy and evaluation perspectives related to regulatory compliance and clinical quality assurance for research and development, with a focus on Good Clinical Practice and minimizing regulatory risk. We are a growing consulting firm and we want you to grow with us!
Be the energetic and motivated individual who'll join a great team!
Reports To: Senior Director, Good Clinical Practice Services
Status: Full-time, salary with comprehensive benefits package
This home-based, full time, salaried position is responsible for providing a diverse, high-end range of clinical research support and clinical quality auditing services. Specialized consultancy provided to clients offers unique opportunities for qualified candidates. Overall job responsibilities include but are not limited to Investigator and Vendor Audits and Assessments, SOP Gap Analyses and SOP Development, Mock Regulatory Inspections.
Primary Responsibilities include:
- Perform domestic Investigator Site Audits and a diverse range of Clinical Research Organization (CRO) and Vendor audits in accordance with either Falcon or Sponsor Standard Operating Procedures (SOPs);
- Perform Data , Clinical Study Report, and Regulatory Submission Audits;
- Conduct GCP Training, Inspection Readiness Training and Training on other Clinical Research Compliance topics to Investigators and Sponsors;
- Perform Inspection Readiness Visits to Investigator Sites and Vendors;
- Participate in Mock Regulatory Inspections at Sponsor Facilities;
- Perform Internal Process/System Assessments and Standard Operating Procedure (SOP) Gap Analyses;
- Assist and support Senior Director/Director-level Falcon GCP Consultants in the evaluation and development of Sponsor Clinical Quality Systems and Infrastructure.
- Degree in Nursing, Science, or related field (or equivalent);
- Minimum of ten (10) years clinical research and/or R & D experience in pharmaceutical, biotech, medical device and other life science industries;
- Minimum of four (4) years working knowledge and experience in Clinical Quality Assurance
- Strong GCP and Clinical Quality Assurance knowledge, other GXP knowledge a plus
- Aptitude and knowledge to perform independent Investigator Site Audits, CRO/Vendor Audits, and other assignments;
- Advanced oral and written communication skills
- Ability to analyze a variety of data points to solve complex problems
- Ability to work independently; planning, organizing, scheduling and completing work within deadlines
- Ability to manage conflicting demands and priorities
- Attention to detail with a high level of accuracy
- Work remotely, within a self-provided designated work space which includes reliable internet connectivity
- Frequent domestic travel ( 60-70%)
It is our strict company policy that all communication is CONFIDENTIAL, without exceptions. Your information will not be shared without your expressed permission and knowledge.
- CVs must have your e-mail address, along with address and phone number. Please submit CVs in a Word document;
- NO CVs will be accepted without salary requirements;
- Equal Opportunity Employer.