Quality Improvement Organization, Research Facility
4 Year Degree
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
Location: U.S. city with close airport proximity
This home-based/remote, 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.
Due to home-based/remote, position could be located in any U.S. city.
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.
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;
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 with potential for some international travel (total travel 60-70%)
Please note: It is our strict company policy that all communication is CONFIDENTIAL, without exception. Your information will not be shared without your expressed permission and knowledge.
Please provide your resume which includes the following contact information: both daytime and evening phone numbers (calls are handled confidentially), address and email
Falcon Consulting Group is committed to maintaining a primary focus on the specific needs and standards of our clients in the pharmaceutical, biotech, medical device and life science industries worldwide.
Proven methodologies are applied in partnership with our clients to deliver customized, value-driven, quality services.
While performing the duties of this job, the employee works in an office environment and is occasionally required to stand; walk; sit; use hands to finger, handle, or feel objects, tools or controls; reach with hands and arms; balance; bend; talk or hear. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by the job include close vision, distance vision, color vision, peripheral vision, depth perception, and the ability to adjust focus.
This position requires regular oral/written interaction with clients, team members and the management team.
Frequent domestic travel with potential for some international travel (total travel 60-70%).
Schulman provides equal employment opportunity to all individuals regardless of their race, color, creed, religion, gender, age, sexual orientation, national origin, disability, veteran status, or any other characteristic protected by state, federal, or local law. Further, the company takes affirmative action to ensure that applicants are employed and employees are treated during employment without regard to any of these characteristics. Discrimination of any type will not be tolerated.
Reasonable accommodation requests for persons with disabilities may be submitted by email or U.S. Mail. If you require reasonable accommodation during any part of the hiring process, please submit requests to email@example.com or mail to:
Schulman Associates Institutional Review Board, Inc.
ATTN: Human Resources Director
4445 Lake Forest Drive, Suite 300
Cincinnati, OH 45242
* Schulman Associates Institutional Review Board, Inc. is the parent company of Falcon Consulting Group
About Falcon Consulting Group (Consulting Division of Schulman IRB)
SCHULMAN Associates IRB, Inc. (“SCHULMAN“) is dedicated to human research subject protection. Since its beginnings in 1983, Schulman has grown to one of the most prominent independent IRB’s in the country, recognized as a technology and customer service leader.