Safety Assistant

Advanced Clinical is a clinical development and strategic resourcing organization committed to providing a better clinical experience across the drug development journey. Our goal is to improve the lives of all those touched by clinical research – approaching each opportunity with foresight, character, resilience and innovation. Based on decades of experience, we help our clients achieve better outcomes by conducting candid conversations and anticipating potential issues through our customized solutions.

The Safety Assistant is responsible for ensuring accurate collection and storage of clinical trial and post-marketing safety data. The Safety Assistant will also assist in following areas: monitor the Safety mailbox during working hours for any new information; create filing systems for safety information in relevant systems; enter safety information into relevant trackers and safety database for tracking purposes; monitor query responses and close out queries; occasional case processing, create final SAE packages for filing in electronic trial master file. In addition, the Safety Assistant will assist with tracking and filing of single and aggregate report submission to regulatory authorities, central ethics committees and institutional review boards, and investigator sites where indicated.

Responsibilities:

• Follow applicable Standard Operation Procedures (SOPs)
• Assist with the creation and maintenance of documentation for clinical studies including but not limited to: training materials, safety management plans, safety forms, presentations and reports with supervision.
• Provide administrative support to the Global Safety Services (GSS) team. Monitor the GSS mailboxes, safety database inbox and fax inbox for incoming data, redact and file incoming data, assign cases to Safety Leads, send acknowledgements and raise/follow up on urgent requests for data from reporters.
• Initial triage and data entry into safety database.
• Update and maintain relevant safety trackers.
• Create and quality check final SAE packages for TMF filing.
• Liaise with AC medical team, clinical sites, reporters and AC project team on adverse events and other safety matters.
• Ensure compliance with global regulatory requirements for drug, device and any other product in all aspects of case processing and regulatory submission for all studies and marketed products.
• Adhere to global privacy laws, ICH GCP and any local regulatory requirements.
• Provide safety training to study teams as needed.

Qualifications:

• 1+ years of safety assistant/safety coordinator experience, preferably within a contract research organization; An equal or greater amount of transferable experience in a different setting will be considered.
• Prior experience of working in a global team.
• Strong computer and software skills including proficiency in use of Veeva Vault Safety database and/or ARISg Safety database (LifeSphere MultiVigilance), Microsoft Word, Excel, Outlook, PowerPoint and Adobe Acrobat. Experience in using other Veeva products also welcome.
• Strong organizational skills and experience working under time constraints.

At Advanced Clinical, our commitment to diversity and inclusion in every part of our organization is crucial to fulfilling our mission and demonstrating our REAL values. A diverse staff allows us to effectively draw on different perspectives and enhance our efficiency and effectiveness. Diversity thereby strengthens the legitimacy and relevance of Advanced Clinical in delivering services to our clients. We seek talented, creative individuals from a variety of backgrounds and cultures to work with us. It is our priority that our workplace be inclusive, welcoming of diverse ideas and appreciative of valuable experience.

Equal Employment Opportunity
It is Advanced Clinical's practice not to discriminate against any Employee or applicant because of sex, race, color, age, national origin, religion, gender, gender identity or expression, sexual orientation or sexual preference, pregnancy or maternity, genetic information, marital status, physical or mental disability, medical condition, military or veteran status, or any other basis protected by applicable federal, state, or local law.

This practice applies to all terms and conditions of employment including, but not limited to, hiring, training, compensation, benefits, promotions, transfers, layoff, Company-sponsored education, social and recreational programs, and treatment on the job. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your Recruiter so that we can meet to discuss the appropriate alternatives available.