Clinical Research Associate

Duration: 12 Months+

The Clinical Operations Associate will perform activities related to the distribution of Safety Alert Reports and Plain Language Summaries globally. The Associate must possess strong computer skills for database management and troubleshooting. The ideal candidate has problem solving and critical thinking skills, meticulous attention to detail, proofreading/QC, and time management skills, which are essential for success in this role. This multi-person, time sensitive, process requires a candidate that is reliable, dependable, and dedicated to ensure deadlines are met.

Essential Functions:

• Assist with the processing of all ICSR and Aggregate documents including, but not limited to: SUSARs, IND Safety Alerts, Six Monthly Line Listings, DSURs etc. 50%
• Assist with the maintenance of the safety alert reporting system including, but not limited to: data maintenance, troubleshooting, and validation testing. 10%
• Develop and apply an understanding of country specific, Regulatory reporting requirements for 50+ countries worldwide 5%
• Identify issues with the distribution/receipt of safety alert reports in order to provide support to the study teams for all inspection readiness activities. 15%
• Interact/collaborate with interdisciplinary groups such as Safety, Study Teams, CROs, and IT in order to resolve distribution issues and resolve incoming inquiries. 5%
• Assist with inspection readiness activities including but not limited to running reports, reconciling reports received and distributed, and gathering information for storyboard development 10%
• Assist with obtaining and tracking key milestone dates including but not limited to Clinical Trial specific SIV, COV, Country Approval, LPLV, and Country Close Out 5%

Requirements:

• Bachelor's Degree required
• 1-3 years of Pharmaceutical experience
• Must be able to analyze issues in order to discover the root cause
• Strong computer skills, particularly experience with database management, data entry, and troubleshooting
• Strong follow through skills are necessary to ensure submissions reach their final destination in a timely manner
• Knowledge of safety report submission activities is a plus
• Strong desire to learn and the ability to quickly grasp multiple skills simultaneously
• Regulatory experience is a plus
• Strong proofreading, editing, and reviewing skills are required
• Must be detail oriented, highly organized, and quality driven
• Possess a strong work ethic and be able to work both as part of a team and independently
• Prior experience dealing with sensitive, or confidential, documentation
• Experience contributing to guidance documents (SOPs/SWPs/User Manuals, Job Aides etc.)
• Strong written, and verbal, communication skills

Shift: Day