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 & Responsibilities
* 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.
* Background in clinical or medical settings advantageous.
* Experience with medical devices viewed favorably.
Seniority Level
Associate
Employment Type
Full-time
Job Function
Research
Industries
Medical Equipment Manufacturing
#J-18808-Ljbffr