In-house Cra Ii

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 collaborate with project team and study sites during recruitment phase, tracking, patient recruitment by contacting investigators as specified for the study, and discuss potential study risks and opportunities with the Project Manager and CTL
4) 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)
5) To provide oversight and management of maintenance activities; to ensure compliance with renewals, document and update according to applicable local regulatory, and IRB/IEC requirements.
6) To perform Case Report Form review, query generation and resolution against established data review guidelines, with or without direct supervision, on Covance or client data management systems, as assigned by management
7) Might be requested to work in a client facing environment as assigned.
8) General On-Site Monitoring Responsibilities per the monitoring plan to include those indicated in the chart below:
ONSITE: Assist Sr. In-House Clinical Research Associate (Sr. IHCRA), Clinical Research Associate 1 (CRA1) with 1+ years of independent monitoring experience, Clinical Research Associate 2 (CRA 2), Senior Clinical Research Associate 1 (Sr. CRA 1) and Senior Clinical Research Associate 2 (Sr. CRA 2) with on-site tasks as required and according to training goals (e.g. review of Case Report Forms, SDR/SDV, Site Regulatory File and drug accountability). All activity to be conducted under direct supervision of the primary monitor.
REMOTE: Perform remote visits (i.e. Phone PSVs, Phone SIVs, remote RMVs, remote COVs) as required by the monitoring plan including remote monitoring that requires SDV/SDR after successful completion of the MEA SDR/SDV training.

9) To provide oversight and management of maintenance activities; to ensure compliance with renewals, document and update according to applicable local regulatory and IRB/IEC requirement.
10) To liaise with local or central laboratories in order to ensure adherence to the protocol, ensuring that all relevant documentation is current e.g., accreditation certificates, normal ranges, etc.
11) To provide site training as needed via phone or teleconference/web meeting
12) To conduct IVRS/IWRS review and reconciliation, ensuring that data is accurate and up to date
13) To liaise with sponsor/medical monitor regarding clinical questions and study status
14) To assist with the coordination of study visits and shipment of drug and laboratory samples
16) 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

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 as per study requirement
18) To liaise with the CTA to assist the project team in the production of status reports
19) To work in a timely manner in accordance with all the activities specified in the agreed study budget, under mínimal supervision and guidance of the Clinical Team Leader (CTL) and Project Manager
20) Assist in submissions and notifications to Ethics Committees and Regulatory Authorities, as applicable in region
21) To facilitate translation and back translation of all necessary documents, as appropriate for local country requirements, as needed regionally
22) To undertake other project related administrative tasks (i.e. 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
23) To attend, as needed, meetings (investigator, sponsor, kick-off, face-to-face) and to present at the meetings
24) Ensure compliance with Covance SOPs, and local regulatory authority regulations for clinical conduct in all aspects of daily work
25) To perform other duties as assigned by management per the monitoring plan to include those indicated in the chart below.

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