1) To serve as contact for project team and investigative sites, conduct site contacts and document contacts for assigned sites as required per study guidelines, including creating contact reports for each telephone session (outbound or inbound) with sites.
2) To monitor site performance and implement action plans for sites not meeting expectations, in conjunction with the CRA.
3) To assist CRAs with preparation for site visits (i.e. running reports, QC of files (checking for missing documents), resolving action items from previous visits).
4) Perform Case Report Form review, query generation and resolution against established data review guidelines, under direct supervision on Covance or client data management systems, as assigned by management.
5) To assist with the coordination of study visits and shipment of drug and laboratory samples.
6) To manage sites to ensure subjects are complying with protocol requirements, study visits, and timelines.
7) To liaise with the project team and others to distribute and track clinical trial supplies, e.g. Case Report Forms, study medication, lab kits, ensuring that sites have sufficient supplies to continue recruitment.
8) To liaise with Study Start-up and assume maintenance activities after Site Activation. Maintenance responsibilities include: revision of FDA form 1572, Medical license expiration, CV (if applicable), Laboratory Certificate expiration, Protocol Signature Page collection, Investigators Brochure acknowledgement of receipt, Institutional Review Board submission/Approval for Annual Renewals and PI Changes.
9) To proactively work with sites and project teams to ensure maintenance activities (including Amendments, revised documents, etc.) are completed for assigned sites as applicable in region.
10) To demonstrate an understanding of the purpose of CTMS, how to use it, and how to navigate within the different sections. To enter weekly details in CTMS or as per study requirement.
11) To liaise with the CTA to assist the Project Team in the production of Status Reports.
12) To work in a timely manner in accordance with all the activities specified in the agreed study budget, under the supervision and guidance of the Clinical Team Leader (CTL) and Project Manager.
13) To assist in submissions and notifications to Ethics Committees and Regulatory Authorities. As applicable in region
14) General On-Site Monitoring Responsibilities: Assist Senior CRAs, CRA-2 and CRA-1 with on-site tasks as required and according to training goals (e.g. review of Case Report Forms Site Regulatory File and drug accountability).
15) Perform remote visits (i.e. Phone PSVs, Phone SIVs, remote RMVs, remote COVs) as required by the monitoring plan, but does not perform remote monitoring that requires SDV/SDR.
16) To facilitate translation and back translation of all necessary documents, as appropriate for local country requirements. As needed regionally.
17) To undertake other project related administrative tasks (i.e. meeting minutes, recruitment tracking, site document preparation) as appropriate, as assigned by the project Manager and CTL Might be requested to work in a client facing environment
18) To attend, as needed, meetings (investigator, sponsor, kick-off, face-to-face) and to present at the meetings.