See JD attached. Same manager as MDTJP00024997 (Pam Haworth)Position Description:The Clinical Research Specialist (CRS) leads and supports multiple activities for the optimal conduct of clinical research, as well as driving clinical initiatives, cross-functional communication and collaboration on key clinical issues and administrative responsibilities to ensure compliance with applicable regulatory standards, IRB policies, and Healthcare internal requirements.Position Responsibilities: Primary responsible for leading or supporting the clinical trial lead on studies and clinical activities to ensure successful conduct of assigned clinical studies and assure compliance with the Protocol/Investigational Plan, Applicable regulatory, IRB, and Healthcare standards, guidelines and policies. Lead or contribute to study team meetings, and follow up on action items Review or help develop protocols, Investigator Brochures, case report forms, informed consent documents, etc Develop and update study-related materials and plans (training materials, study plans, patient materials, etc) and ensure appropriate approvals before implementation Track sponsor and site training, IRB approvals, site documents (CV, medical licenses, etc), and monitoring activities Track and manage study enrollment Complete site initiation and activation activities Conduct trial master file reviews Contribute to accurate and timely study status reports to study team and management and follow action items through resolution. Maintain documentation to be consistent with regulations and SOPs. Support or lead efforts for vendor selection , negotiation and execution of contracts and payments Work with Operations with device management (e.g., forecasting, procurement, shipment and receipt, accountability, failure analysis, SAP transactions). Determine obstacles, identify solutions, and implement plans in collaboration with the study team to meet study objectives, scope and schedules Ad hoc projects as assigned in the optimization of procedures and processes. Identify barriers of inefficiencies to flush out and streamline best practices. Works within and actively promote Healthcare s core mission, corporate strategies, policies, procedures and Code of Conduct.Basic QualificationsEducation Required Bachelor s degree, preferably in SciencesYears of Experience 2+ years of experience in academia, medical device, biologics, or pharmaceutical industry (1+ years is holds Master s degree) Work Experience directly supporting clinical research or similar experience in a medical/scientific areaSpecialized Knowledge or Skills Required Experience with GCPs and regulatory compliance guidelines for clinical trialsDesired/Preferred Qualifications: This is an optional section, and can include things not easily identified from the resume, but more likely to be explored during the interview process. Knowledge of Diabetes Good written and oral communications skills, with proficient knowledge of medical terminology. Experience in working in cross functional environment, with Research and Development, Regulatory, International and Legal organizations. Proficiency in word processing, spreadsheets applications (e.g., MS Word and Excel) Experience in clinical trials, industry experience (medical device preferred) Strong verbal and written communication skills, technical and problem solving skill Able to read, analyze and interpret general business documents, technical procedures, and specifications Able to work effectively, independently and on cross-functional teams Able to write reports, business correspondence and procedure manuals effectively Able to frequently use general knowledge of industry regulations, practices, techniques, and standards Develops solutions to a variety of problems of moderate scope and complexity Able to refer to policies and regulations for guidance Willing to be flexible with work hours Attention to detail and accuracy and ability to manage multiple tasks.
Select Source International is a Global Solutions provider of IT staffing and Project services. Our service offering has 5 main practices; ERP, Application Development, Middleware, Database Management and Project Services. SSI offers industry leading Data Migration, Compliance, and Risk Management through its subsidiary Data Wave. Data Wave offers Cyber Security and risk management through a GRC product suite called Risk Utilities. In addition to our technology offerings, SSI also provides administrative and business consulting services. Industry Experience: Retail Healthcare Manufacturing Energy and Utilities Government Financial Engineering