Founded in 1979, Technical Resources International, Inc. (TRI) provides a unique range of support services in the areas of Communications, Health and Information Technology to both private industry and government agency clients. TRI is currently seeking an In-House CRA who is a dedicated team player to join our Bethesda, MD team.
This position will review and process essential regulatory documents received from clinical trial sites; request additional information when necessary; respond to protocol and process-related queries; maintain trial master files, and track the process in a centralized Web-based system and/or other databases. Requirements include Bachelor’s degree in life sciences or other health-related field; 0 - 2 years of experience in the clinical research arena; and proficiency with Microsoft Office.
Essential Duties and Responsibilities:
• Review essential regulatory documents (ERD) for accuracy and completeness as required by FDA Regulations, ICHGCP, Sponsor’s Requirements and SOPs.
• Essential regulatory document collection, tracking, and transmittal using electronic systems, interfaces, and databases.
• Adherence to strict project timelines and expectations.
• Troubleshoot ERD issues by applying existing knowledge to solve new problems
• Experience with essential regulatory document review/collection and knowledge of applicable FDA ICH/GCP guidelines/regulations in a pharmaceutical, clinical research, or clinical site, sponsor, or CRO setting (i.e., In-house CRA, Study Coordinator, IRB Coordinator, and Regulatory Coordinator/Associate/Specialist).
• BS degree in health-related field or Licensed Practical Nurse.
• Experience with IRB submissions (OHRP regulations) is a plus.
Knowledge, Skills, and Abilities:
• Must have excellent time management skills.
• Able to identify activities along critical path toward individual site activation.
• Able to multi-task during the review/processing and preparation of essential regulatory documentation.
• Able to negotiate with difficult investigators, research nurses, and site staff to reach desired resolution.
• Demonstrated understanding of medical and clinical trials terminology.
• Able to work independently or with minimal supervision with multiple sites simultaneously and handle multiple tasks effectively while keeping up with rapid changes of priorities without loss of efficiency.
• Demonstrated understanding of applicable ICH/GCP/FDA Guidelines and Regulations, sponsor-specific requirements, and Standard Operating Procedures/Project Work Instructions.
• Knowledge of SAS programming and use a plus
• Excellent professional writing and verbal communication skills.
• Must be self-motivated and have a positive attitude.
• Excellent organizational and coordination skills with strong attention to detail.
Submit resume and salary requirements to: Attn: MH, TRI, 6500 Rock Spring Dr, Suite 650, Bethesda, MD 20817, or fax to (301) 897-1702, or email to HR@tech-res.com.
Technical Resources International is fully committed to Equal Employment Opportunity and to attracting, retaining, developing and promoting the most qualified employees without regard to their race, gender, color, religion, national origin, age, physical or mental disability, veteran status, or any other characteristic prohibited by state or local law.