Summary of Key Responsibilities:
• The SCRA is a high-profile role within the department; using their experience as a knowledge resource
• to help other CRAs develop their skills.
• The SCRA will provide expert advice, guidance and general supervision to clinical monitoring team activities for designated projects, and to monitor specified sites to ensure quality and integrity of data, compliance with client's standard operating procedures (SOPs), clinical monitoring plan, ICH GCP, regulatory requirements, ensuring study completion on time and within budget.
• They may be called upon to interact independently with clients not directly involved in their projects, and to assist in some relevant departmental tasks.
• The SCRA is an essential member of a Development Innovations project team responsible for the execution of a clinical research project.
• The degree of responsibility given to a SCRA shall reflect his/her experience and the level of contribution, which he/she can make to that project.
Duties and Responsibilities:
Duties include but are not limited to:
• Reports directly to Manager, CRAs on general issues
• Reports to the Project Manager or Project Lead for study specific issues
• Conduct all activities according to the defined project-specific quality and performance standards as well as relevant SOPs, ICH/GCP, and local requirements
• Contribute to the departmental on-site Quality Control program by setting a schedule of site assessment visits for the project for agreement with the development innovations monitoring management team, and conducting agreed co-monitoring visits with members of the development innovations monitoring project team
• Ensure awareness of project-specific quality and performance standards (within Development Innovations Monitoring Standards) and ensure that these are adequately documented, communicated, and understood
• To be accompanied by Project Manager, Project Lead, or CRA Manager on selected visits (qualification, initiation, monitoring, and close out visits.)
• To support the development and delivery of department training days
• Actively participate in training sessions and workshops, including presenting reports from any conferences attended
• Assist in the Investigator selection and qualification process
• Assist in the development of patient recruitment strategy
• Attendance at Investigator Meetings
• Perform and document pre-study site evaluations, site initiations, regulatory document collection, interim monitoring and study close out visits in accordance with GCP, study-specific requirements, clinical monitoring plans, company SOPs, applicable regulatory requirements and defined quality and performance standards
• Ensure site IRB approval is current and all IRB documentation is in order
• Maintain site monitoring schedule and serve as the principal point of contact for investigational sites
• Document and report on clinical study progress, i.e. patient recruitment and discuss potential opportunities and risks with respective Project Team members
• Ensure patient safety is maintained and informed consent procedures are carried out
• Provide training and update investigative site team of any changes in study conduct and documentation requirements
• Ensure continued acceptability of the investigator, clinical site team and facility
• Review clinical data, source documentation, CRF, and investigative site regulatory files
• Work closely with data management and site to resolve discrepancies
• Ensure investigational product accountability accuracy and oversee investigational product inventory
• Liaise with vendors such as central laboratories as required to ensure protocol adherence and ensure investigational sites have appropriate clinical supplies
• Meet with clinical study sponsor representatives, as requested
• Submission of routine monitoring visit reports and follow-up letters as per required timelines
• Ensure resolution of issues with investigative sites
• Attend meetings as assigned and report on actions
• Participate in educational activities and programs
• Maintain strictest confidentiality
• Work closely and effectively with all other department personnel to ensure appropriate communication and study conduct
• Assist other staff as requested and perform other related work, as needed
• Function as a mentor for team members
• Maintain awareness of current developments in therapeutic area relative to assigned projects
• Throughout the conduct of the clinical trial assesses adherence to SOPS, GCP and all applicable regulatory requirements
• Travel is required. May also involve travel to meetings or attendance at conferences. Overnight stays may also be required. In addition, weekend and evening sessions may be required depending upon the workload and nature of current programs