Job Purpose

• Perform all required activities to ensure appropriate monitoring of investigator sites and trial execution under the supervision of the COM – typically for clinical trials of larger scope and/or higher complexity which, as compared with the CRA level, may include

• Greater number of sites

• Greater number of trials

• Complex design and protocol

• Primary person responsible for management of assigned sites, including acting as central point of communication between client and Investigator sites (except when assigned to a trial performed through a CRO – see below)
• May have management responsibility of CRA and Jr. CRAs

Major Accountabilities

When Assigned to In-House Studies:

• Perform monitoring visits according to monitoring plan (including trial initiation, training and closeout activities)
• Participate in site nomination process, perform evaluation of site capability and make recommendation for inclusion in clinical trial
• Point of contact for sites and facilitator of communication between sites and key  line functions
• Ensure preparation, collection and distribution of trial master file documents and maintenance of investigator site file
• Timely write-up of study monitoring visit reports
• Set up and ensure maintenance of investigator site file
• Manage site vaccine supply and sample management during course of study
• Ensure site performance in line with milestones and KPI’s (i.e. start-up, recruitment, closeout, etc.)
• Support investigator in implementing appropriate contingency plans as needed
• Assure continual compliance with GCP, ICH and our client’s SOPs in informed consent process, source data verification, AE and SAE reporting, protocol execution, vaccine accountability, and other tasks as specified.  Resolve deviations to standard through remedial action and training
• Escalate any issues regarding study conduct to his/her manager as needed

 When assigned to CRO Trials:

• Many of the above responsibilities could still apply but primarily their role in these cases is:
• Support CTM as required in relationship management tasks (e.g. contracts, sample management, supplies, etc) and evaluating CRO and site performance
• Review CRO monitoring visit reports and ensure appropriate follow up and escalation of issues identified; occasionally, co-monitoring with CRAs from CROs

Ideal Background   

• A higher education degree in a scientific, health care, or other related discipline required.  Relevant experience in lieu of formal education as an exception only
• Excellent knowledge of written and spoken English (and local language as applicable)
• 3-5 years field monitoring experience
• Understands and can apply knowledge of clinical trial designs to trial execution
• Advanced knowledge and experience with international standards (GCP/ICH), international and national (FDA, EMEA) and local regulations
• Expertise in communication, managing multiple priorities and computer literacy

Key Performance    

• Delivery of high quality data according to agreed timelines and budget, ensuring adherence to international and local regulations and client’s SOP standards according to KPI’s established by the Vaccines Development
• Feedback of external (investigators) and internal customers