Clinical Research Specialist

Overview:Reporting to management, this Clinical Research Specialist will contribute to one or more clinical studies within the Clinical R&D team, collaborating closely with colleagues throughout the organization.Key Duties & ResponsibilitiesIn line with applicable federal, state, and local laws, and following all relevant company policies and procedures, this role will:Provide operational support for company-sponsored clinical studies, helping ensure adherence to project deadlines and established milestones, under guidance.Assist in evaluating, launching, managing, and closing clinical trials within designated regions, complying with ICH-GCP guidelines, local legislation, and organizational Standard Operating Procedures.Potentially act as the main point of contact for research sites, including site management activities.Support the development and maintenance of essential clinical trial documentation—including protocols, informed consent forms, case report forms, monitoring plans, study manuals, investigator brochures, and annual progress reports.Facilitate trial registration and post-study reporting (e.g., on clinicaltrials.gov) and aid publication efforts as required.Handle ordering, tracking, and oversight of investigational devices and other study materials.Engage and collaborate with site staff, ethical review boards, external partners/vendors, and internal personnel.Work closely with Clinical Research Associates (CRAs) and other team members.Assist in preparing and managing investigator agreements and processing payments related to clinical studies.Support the review and preparation of clinical data for statistical analysis and publication purposes.May perform site management visits, including site qualification, initiation, interim monitoring, or closure visits as needed by the study.Provide on-site guidance to ensure protocol compliance and accurate data collection.Help oversee and monitor assigned budget allocations for projects.Serve as a dependable source of accurate, current project information for stakeholders.Build a comprehensive understanding of the development pipeline, product portfolio, and business objectives.Typically operates with supervision; makes independent decisions for routine matters, but seeks advice for complex situations.Relay business-related concerns or opportunities to appropriate management levels.Adhere to all guidelines regarding health, safety, and environmental standards, and ensure compliance by direct reports when applicable.Ensure both personal and organizational compliance with federal, state, local, and internal policies and procedures.Perform additional tasks as assigned.Clinical Safety Coordination (may be included):Coordinate all safety-related aspects of clinical trials.Plan and execute new safety initiatives.Develop safety management plans and workflows for clinical research, within all relevant safety regulations.Collaborate with key stakeholders—such as medical teams, study sites, regulatory affairs, and data management—regarding safety activities in clinical studies.Work with data management teams to ensure prompt notification of safety events.Gather required information regarding safety events with the study team.Team with cross-functional groups (R&D, complaint handling, quality/regulatory affairs, medical affairs, medical safety) to ensure compliance with safety reporting.Facilitate review of clinical safety data alongside study teams and medical counterparts.Manage the study safety communications inbox and coordinate timely reporting of adverse events to regulatory authorities and ethics boards.Prepare safety reports for dissemination to stakeholders, investigators, ethics committees, and regulatory authorities.Aid in the scheduling and organization of safety adjudication processes.Arrange and coordinate safety board meetings, acting as a point of contact for all related queries.Ensure all safety documentation is routed to the appropriate personnel.Education:Bachelor’s degree (preferably in Life Sciences, Nursing, Physical Sciences, or Biological Sciences) required.Experience:Bachelor’s degree with at least 2 years, or Master’s/PhD with at least 1 year of relevant experience preferred.Previous experience in clinical research or a comparable field desirable.Professional certifications a plus (e.g., CCRA, CCRC, CCRP, RAC, CDE, GCP, ISO 14155, MDR, MEDDEV).Background in clinical or medical settings advantageous.Experience with medical devices viewed favorably.