Medical Monitor Safety Admin (Mid/Night Shift)

Key Details
• Experience Level: Junior (1 to 2 years)
• Job Type: Full Time
• Visa Sponsorship: Unknown
• Industries: Pharmaceuticals, Biotechnology, Medical Research
Responsibilities

The Drug Safety Admin Associate II will coordinate the timely review of protocol inquiries, serious and non-serious adverse events, diagnostics, and Data Safety Monitoring Board (DSMB) data, track all necessary data and generate flawless reports for clients, project teams, and external vendors, represent the DSMB/EAC Coordination Team at global and domestic committee meetings, coordinating all logistical aspects and assisting with facilitation, collaborate with internal and external parties to implement projects, prepare Confidentiality Disclosure Agreements, Letters of Intent, and Member Agreements, ensuring all contractual documents are accurate and approved, compile adjudication dossiers and build/submit follow-ups to investigative sites, coordinate and facilitate project meetings, draft meeting minutes, post blinded and unblinded minutes/materials to client portals, and distribute to project teams, manage project-specific training and the setup, maintenance, and archival of program files, ensuring audit readiness, identify and redact subject identifiers per local requirements, train sites, and bring up reoccurrences to Data Privacy, perform data entry into internal/external databases, tracking systems, and budget management systems; perform system reconciliations to identify potential issues, coordinate expenses and manage translations, ensuring budget parameters are met, answer hotline calls, coordinate department functions, and perform other duties as assigned, support activities specific to the local office that cannot be performed elsewhere, provide training to junior staff.
Requirements

Candidates should possess strong problem-solving skills, the ability to work independently with minimal supervision, demonstrated ability to foster positive relationships, effective in analyzing project-specific data/systems for accuracy and efficiency, skilled in acting as a liaison and communicating diplomatically with clients, management, and team members, self-motivated with a positive attitude and excellent communication skills, proficient in MS Office (Word, Excel, PowerPoint, Access), ability to prioritize tasks and meet strict deadlines, strong attention to detail and meticulous work orientation, professional demeanor in challenging circumstances, and flexibility to adapt to changing project timelines. Knowledge of FDA Regulations, ICH Good Clinical Practices, and SOPs for non-clinical/clinical project aspects is required.

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