Safety Associate

This is a fully remote position, open to applicants in United States.

📋 Description

• Enhance operational excellence by overseeing and refining processes for ICSRs, CECs, and DMCs.

• Gather, evaluate, analyze, and input ICSR data into tracking, regulatory reporting, and Safety database systems.

• Compose ICSR narratives and elucidate medical conditions, lab results, and medical procedures.

• Identify follow-up data necessary for ICSR completion and distribute ICSR notifications to study teams and Sponsors.

• Engage in ICSR reconciliation between Clinical and Safety databases.

• Utilize MedDRA for terminology coding.

• Create and uphold Safety department SOPs, guidelines, templates, and training resources.

• Independently prioritize work tasks and maintain departmental performance and quality metric tracking tools.

• Attend study team and company meetings, provide status updates, and monitor action items.

• Support quality assurance initiatives, including audits.

• Stay informed about Good Clinical Practices, Good Vigilance Practices, Safety writing practices, and data-entry conventions.

• Mentor and guide less experienced Safety team members and non-Safety personnel.

• Co-author Safety project documents specific to studies and ensure adherence to compliance requirements.

• Remain knowledgeable about the study protocol sections related to Safety services.

• Participate in the design, testing, and maintenance/use of electronic systems supporting CEC, AE Reporting, and Safety services.

• Employ Electronic Data Capture and Safety Database systems for data entry, AE review, and query creation/resolution.

• Collaborate with Sponsors and internal departments to ensure data quality and precision.

• Contribute to departmental quality control activities.

• Serve as CEC coordinator, managing member documentation, contracts, adjudication tracking, and document packages.

• Act as DMC coordinator, handling member documentation, contracts, meeting scheduling/moderation, and documentation of action items/minutes.

• Maintain knowledge of Safety services within work orders and assist with invoicing and billing matters.

• Prepare aggregate Safety reports and submit final reports to Regulatory Authorities or Sponsors.

• Assist with the upkeep of the Trial Master File for Safety-related documentation.

• Undertake additional related tasks as assigned by Management.

⛳️ Requirements

• Bachelor's degree from a four-year college or university in Life Sciences or a related field; or RN diploma.

• At least 1 year of experience in CEC, DMC, Safety reporting, and/or ICSR case processing preferred, or a Medical Degree, RN, PharmD with clinical research experience.

• Experience with EDC databases and/or Safety databases is required.

• Strong understanding of industry acronyms and medical terminology.

• Proven organizational and time-management abilities.

• Proactive professional demeanor focused on compliance and responsibilities.

• Excellent verbal and written communication skills.

• Strong interpersonal skills.

• Ability to work collaboratively and effectively within a team setting.

• High attention to detail, accuracy, tact, judgment, and discretion.

• Proficient in Microsoft Office, including Outlook, Word, and Excel.

• Skilled in learning and utilizing software applications and computerized systems, including Electronic Data Capture systems and project management tools.

• Capability to perform basic searches via the internet or similar data repositories.

• Travel is not anticipated.

• Extensive use of a computer keyboard and ability to perform the stated physical duties, with reasonable accommodations available.

🏝️ Benefits

• Option for remote work.

• Opportunity for onsite work.

• Commitment to equal employment opportunity.

• Pre-employment background checks and drug screening processes aligned with local, state, and federal laws.