Safety Associate

RQM+

118d

About The Position

The Safety Associate (SA) assists with successful planning, implementation, and execution of contracted safety management activities. Under the guidance of the Safety Manager, the SA is responsible for monitoring and processing Adverse Events, supporting CEC and DSMB management, assisting with applicable regulatory reporting, and serving as a resource on safety-related issues. Assures clear client and internal team communication, process documentation, and compliance with applicable US and international regulations, Good Clinical Practices and procedures set forth by RQM+ and its clients.

Requirements

• Bachelor's degree or RN in life sciences or healthcare related field.
• Minimum of 3 years in related field. Minimum of 3-years direct experience in clinical studies, preferably in drug/device safety or CRA position.
• Equivalent combination of education, training, and experience.
• Thorough knowledge of and experience in clinical research process from study start up through archiving of TMF, including Interim analysis and database lock.
• Robust understanding of general anatomy, physiology and pathological processes.
• Applicable knowledge and understanding of safety events, data queries and reporting relative to medical devices.
• Knowledge and understanding of global processes, regulations, and reporting requirements for medical device and pharma.
• Prior or current knowledge of Clinical Event Committee and Data Safety Monitoring Committee workflows.
• Good knowledge of medical terminology and reporting obligations.
• Working knowledge of applicable Safety Database and any other internal/Client applications.
• Knowledge of applicable global, regional, local clinical research regulatory requirements.
• Prior experience in electronic data capture (EDC) required.
• Excellent attention to detail and accuracy, maintain high quality standards.
• Good working knowledge of Microsoft Office, electronic signature platforms and web-based applications.
• Self-motivated and flexible to meet the needs of the department.
• Excellent organizational, time management and interpersonal skills.
• Ability to follow instructions/guidelines, utilize initiative and work independently.
• Ability to manage competing priorities and deadlines within various clinical trials.
• Willingness and aptitude to learn new skills across Safety service lines.
• Ensure quality of deliverables according to the agreed terms.
• Flexibility to operate in shifts.
• Up to 20% travel may be required including international travel.
• Strong communication skills (verbal and written) to express complex ideas.
• Excellent and demonstrated organizational and interpersonal skills.
• Ability to work independently, prioritize and work within a matrix team environment.

Responsibilities

• Exhibit subject matter expertise in clinical trial conduct and safety with a focus on medical device studies, as well as combination products and software as medical device.
• Process Safety data according to applicable regulations, guidelines, Standard Operating procedures (SOPs) and project requirements.
• Gathers, reviews and interprets source documentation from clinical sites to formulate a cohesive narrative for safety events.
• Perform Pharmacovigilance per project requirement including but not limited to, collecting, and tracking incoming Adverse Events(AE)/endpoint information.
• Determine initial/update status of incoming events.
• Review and evaluate adverse events to determine if they meet regulatory reporting requirements.
• Database entry in commercial and validated safety database.
• Coding AEs in accordance with MedDRA and WHO Dictionary and writing case narratives, literature related activities as per internal / project timelines.
• Assist in development of project-specific safety management plan, safety committee charters, procedures, workflows, and templates.
• Safety Committee support and coordination; obtain electronic signatures, onboarding members, member management, manage and facilitate meetings, prepare materials, assist with documentation, document maintenance, and liaising with study personnel.
• Ensure to meet the expected productivity, quality standards and delivery standards per project requirements and department KPIs.
• Identify quality problems, if any, and bring them to the attention of a senior team member.
• Contribute to identification, development, and implementation of safety management initiatives and process improvements.
• Assist with risk assessment activities and implementation of effective control measures and corrective action solutions, as required.
• Mentor new team members, if assigned by the Sr. Manager.
• Attend project team meetings and provide feedback to operations manager on any challenges/issues or successes.
• Collaborate with cross-functional teams to ensure compliance with regulatory requirements related to device safety and pharmacovigilance.
• Prioritize and complete the assigned training on time.
• Perform other duties as assigned.

Benefits

• Industry leading compensation package.
• Focus on work life balance.
• Ongoing learning and development opportunities.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: Bachelor's degree
• Number of Employees: 101-250 employees