The Clinical Research Specialist I provides clinical research expertise by participating in the design and implementation of research projects as needed. Responsible for specific and assigned aspects of research infrastructure development, coordinates projects, and communicates status and improvement areas to leadership. May implement and coordinate department-wide initiatives such as research quality management or clinical trial recruitment efforts. Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board (IRB).

• Provides clinical research expertise by participating in the design and implementation of research projects as needed by the department or institution.
• Responsible for specific and assigned aspects of research infrastructure development and/or maintenance.
• Coordinates research projects at an institutional or departmental level.
• Communicates project status and improvement areas with leadership in a timely manner.
• Projects may include, but are not limited to investigator-initiated protocol development including protocol writing, case report form development, budget development, and coordination of departmental research committees.
• May implement and coordinate department-wide initiatives such as research quality management or clinical trial recruitment efforts.
• Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board.
• Maintains research practices using Good Clinical Practice (GCP) guidelines.
• Maintains strict patient confidentiality according to HIPAA regulations and applicable law.
• Participates in required training and education programs.

• Assists in establishing processes and procedures for all Quality Assurance (QA) and Quality Control (QC) functions of the SOCCI Cancer Clinical Trials Office (CCTO) to include industry sponsored studies, investigator-initiated studies, and cancer cooperative group trials
• Conducts routine and for-cause quality assurance audits or oversees audits of all SOCCI cancer clinical trials
• Establishes effective documentation of audit and monitoring procedures for new and incumbent staff
• Assists with orientation and training for CCTO staff and research faculty as related to research quality measures
• Works within the core and with colleagues outside the core to establish efficient and comprehensive procedures for compliance with CSMC IRB and external sponsors for the conduct of routine and regular clinical research, IIT monitoring and audits
• Using a risk based model or equivalent, assists with the identification and/or selection of trials to be reviewed under QMC
• Responsible for identifying and reporting to her supervisor and leadership as needed, areas of concern and/or assesses gaps through routine reviews and may develop process improvements, new policies/work instructions or other documents based on observations through quality management reviews and audits.
• Lead training seminars, organize webinars or other training/education activities to improve quality
• Generates and maintain quality management records, trackers and applicable reports
• Develops other processes or systems to support quality management core
• Work as a specialist in the SOCCI CCTO Quality Management Core, as a Quality Assurance Monitor by conducting reviews in the following categories:
• Audit Preparations (APs)
• Internal /Educational Reviews (IERs)
• Investigator-Initiated Trial Monitoring Reviews (IITMRs)
• Audits
• Eligibility Verifications (EVs)
• Track the reviews and visits and provides reports on activity and findings
• Schedule audits, prepare documents, oversee all logistics
• Communicate any critical compliance risks noted from these activities to senior management.
• May lead or participate in agency inspections (preparation, conduct, and responses).
• May work with Director on global monitoring initiatives
• May develop policies/work instructions related to quality management
• Local travel required for monitoring of affiliate/satellite sites
• Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board.
• Maintains research practices using Good Clinical Practice (GCP) guidelines.
• Maintains strict patient confidentiality according to HIPAA regulations and applicable laws.
• Participates in required training and education programs.

Requirements:

• Bachelor's Degree required.
• Three (3) years minimum experience in area of research specialty.

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