Careers
Project Manager
The Clinical Project Manager is the primary person responsible for the planning and execution of assigned clinical trials. This encompasses all aspects that impact the completion of the trial and include development of study project plans, problem solving all trial related issues utilizing available resources, initiation and monitoring of trials in progress, completion, reporting and publication of study results. The position ensures all studies are executed within predefined timelines & budgets and are conducted in compliance with GCP and all applicable standards & regulations.
Clinical Research Associate
The Clinical Research Associate (CRA) will perform monitoring and site management activities for Phase I-IV clinical research projects to assess the progress of clinical projects at assigned investigative/physician sites (either on site or remotely) and to ensure clinical projects are conducted, recorded, and reported in accordance with the protocol, Company and Sponsor standard operating procedures (SOPs), ICH-GCP, and/or all applicable local and federal regulatory requirements.
CRA Manager
The CRA Manager in collaboration with project team leaders is responsible for planning, monitoring and coordinating clinical research studies at external study sites. As part of these activities, the CRA Manager will oversee the CRAs for which they are assigned. The CRA Manager ensures monitoring metrics are adhered to and all monitoring deliverables are provided with high quality and consistent with SOPs and project Plans.
Clinical Trial Manager
The Clinical Trial Manager (CTM) collaborates with the Clinical Project Manager to review budgets, make changes where necessary, and outline project together with client and clinical monitoring team. The CTM will be responsible for the operational management and the oversight of clinical trials within a clinical development program. This individual will be responsible for the successful execution of clinical trials from the protocol concept through the clinical study report, ensuring completion of study deliverables. Providing oversight of the CRO and other third party vendors on assigned study. The CTM will work closely with a Project Leader, or Pharmacovigilance, Regulatory, etc., and will report into the Chief Medical Officer.
Clinical Research Coordinator
The Clinical Research Coordinator (CRC) is responsible for a variety of activities in support of clinical research studies. The CRC carries out all aspects of the care and treatment of clinical research subjects in compliance with study protocols throughout the research study. The CRC is required to have knowledge of protocol design and Good Clinical Practices (GCP) as set forth by the Federal Regulations and International Conference of Harmonization (ICH) Guidelines for the protection of human subjects. The CRC will help ensure protocol compliance, Investigational Product accountability and proper follow-up during the clinical trial.
Clinical Trial Assistant
The Clinical Trial Assistant (CTA) assists in all clinical team activities pertaining to study start-up, oversight, and closure; this includes coordination, preparation and assembly of clinical trial supplies and materials for distribution to clinical sites with minimal/moderate supervision. The CTA will assist in maintaining files and tracking of all written and electronic documentation for all study records and site interactions in the Trial Master File (TMF) and shared folders. The CTA is familiar with GCP, FDA regulations, and relevant Standard Operating Procedures for clinical research.
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