Global Solutions Network (GSN), a federal government contracting firm, presents this full time, long-term position supporting GSN's customer at the National Institutes of Health (NIH). This position provides a competitive salary and comprehensive benefits.

If interested, please provide your most up-to-date resume.

Technical Requirements:

• Facilitate working groups to collaborate and write project specific SOPs, work instructions and other documents to develop and harmonize operational processes. Identify new processes, build teams, lead working group meetings, develop and negotiate ideas from concept to written approved process.
• Provide document management (document control) support. Includes participation in the development of organized system tools for tracking of specific clinical trial documentation received and by DAIT quality assurance.
• Support the DAIT Quality Assurance Manager, DAIT ORA in the development and implementation of the Division’s electronic Clinical Quality Management System (Master Control).
• Participate in quality assurance activities related to the close out of DAIT projects (such as file audits, tracking, reconciliation and transfer of clinical documents into long term archival facility).
• Provide administrative support to the COR (Contact Officer Representative) who is responsible for management of the DAIT Regulatory Management Center (RMC) Contract in ensuring compliance with requirements of the contract (e.g., reviewing quarterly progress reports and other deliverables).
• Perform quality assurance review of Office of Regulatory Affairs documents to include (but not limited to) contract agreements, audit reports, and other related clinical documents.
• Attend and assist in the planning and facilitation of Office of Regulatory Affairs team meetings.
• Coordinate the development of various QA related metric reports.
• Assist in the management of Division contract records. Tasks include the following:
• Upload documents and input key information (such as agreement status, program, drug information) into the Clinical Trial Agreement Livelink database.
• Reconcile information stored in the database with corresponding hard copy records.
• Generate contract (clinical trials agreements, confidentiality agreements, etc.) tracking numbers and templates from the database to provide to staff.
• Generate metric reports (from database) related to the contract agreements tracked in the database.
• Provide status updates to team members regarding agreement status and disposition.

Specific Qualifications:

• Bachelor’s degree in a related discipline.
• Minimum of five (5) years of experience in clinical research or a related field.
• Knowledge of clinical quality management and systems (such as Veeva, Master Control, etc.) is preferred.
• Excellent communication, grammar and writing skills required.
• Demonstrated superior knowledge of research protocols and clinical, scientific and/or medical terminology.
• Demonstrated superior experience with data collection.
• Demonstrated experience with Microsoft Office (Word, Excel, etc.).

Global Solutions Network, Inc. (GSN) is an Equal Employment Opportunity (EEO) employer. It is the policy of the GSN to provide equal employment opportunities to all qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected US veteran or disabled status, or genetic information.