Career Opportunities

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!

 

Senior Consultant,
Good Clinical Practice Services

Reports To: Senior Director, Good Clinical Practice Services

Status: Full-time, salary with comprehensive benefits package

Position Summary:

This home-based, full time, salaried position is responsible for providing a diverse, high-end range of independent clinical quality auditing services and other clinical research support. Specialized consultancy provided to clients offers unique opportunities for qualified candidates. Overall job responsibilities include but are not limited to global compliance, quality assurance, clinical trial oversight, Investigator and Vendor Audits and Assessments, SOP Gap Analyses and SOP Development, Mock Regulatory Inspections.

 

Primary Responsibilities include:

  • Perform domestic (and potentially some international) 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;
  • Perform quality control (QC) of documents and data
  • Assist and support Senior Director/Director-level Falcon GCP Consultants in the evaluation and development of Sponsor Clinical Quality Systems and Infrastructure.

 

Position requirements:

Education/Training/Experience: 

  • 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  

 

Knowledge/Skills/Abilities:

  • 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;
  • Experience in performing internal systems assessments and safety/pharmacovigilance audits preferred
  • 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%)   

 

 

 

Associate Director,
Good Clinical Practice Services

Reports To: Senior Director, Good Clinical Practice Services

Status: Full-time, salary with comprehensive benefits package

Position Summary:

This home-based, full time, salaried position is responsible for supervising and 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. Diverse services provided include: Investigator and Vendor Audits and Assessments, Data and Document Audits, SOP Gap Analyses and SOP Development, and Mock Regulatory Inspections. Applying working knowledge and GCP/Clinical Quality Assurance (CQA) expertise, you will provide consultancy services, serve in a team leadership role and operate as a client liaison.

 

Primary Responsibilities include:

  • In conjunction with Senior Director, provide oversight of GCP/CQA Consulting Services provided to Clients pertaining to global compliance, quality assurance and clinical trial oversight;
  • Assist in the supervision and allocation of resources to Client projects;
  • Provide training and oversight, and serve as a mentor to departmental staff members and independent sub-contractors;
  • Perform consultancy services for clients, at times serving in a lead role, establishing, cultivating and maintaining relationships with specific clients as the primary point of contact for all service-related client communication and cross-project issues;
  • Participate in Management and Infrastructure Support Meetings;
  • Evaluate processes and gauge ongoing procedural compliance within GCP services and influence process improvement initiatives;
  • Represent Falcon on Business Development /Sales calls;
  • Advise on the development of departmental Standard Operating Procedures, Guidelines and other tools to support Client consulting services;
  • Other duties as assigned

 

Position requirements: 

Education/Training/Experience: 

  • Degree in Nursing, Science, or related field (or equivalent);
  • Minimum of ten (10) years clinical research and/or R & D experience in pharmaceutical, biopharmaceutical, medical device and other life science industries;
  • Minimum of ten (10) years working knowledge and experience in Clinical Quality Assurance.

 

Knowledge/Skills/Abilities:

  • Strong GCP and Clinical Quality Assurance management experience and knowledge; other GXP QA experience a plus
  • Aptitude and knowledge to provide oversight of, and perform independent Investigator Site Audits, CRO/Vendor Audits, and other assignments
  • Advanced oral and written communication skills
  • Project management and team building 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
  • Ability to do domestic travel (up to approximately 35%).

 

 

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.

 

 

Please apply via our online Job Board!