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 support 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.
3) To monitor site performance and implement action plans for sites not meeting expectations, in
conjunction with the CRA.
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) Perform CRF review, query generation and resolution against established data review
guidelines, and Covance or client data management systems, as assigned by management
6) Might be requested to work in a client facing environment.
7) Independently perform CRF review; query generation and resolution against established data
review guidelines on Covance or client data management systems as assigned by management
8) Responsible for all aspects of study site monitoring with or without direct supervision per the
study monitoring plan. This includes remote and/or onsite conduct of pre-study visits, site
initiation visits, routine monitoring visits and close-out visits of clinical sites.
9) Perform remote visits (i.e. Phone PSVs, Phone SIVs, remote RMVs, remote COVs) as required
by the monitoring plan.
10) Independently responsible for all aspects of study site monitoring either as the primary monitor
or the co-monitor per the study monitoring plan
11) 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
12) To provide site training as needed via phone or teleconference/web meeting.
13) To conduct IVRS/IWRS review and reconciliation, ensuring that data is accurate and up to
14) To liaise with sponsor/medical monitor regarding clinical questions and study status.
15) To assist with the coordination of study visits and shipment of drug and laboratory samples.
16) To manage sites to ensure subjects are complying with protocol requirements, study visits, and
17) To liaise with the CTA and CRA to distribute and track clinical trial supplies, e.g. CRFs, study
medication, lab kits, ensuring that sites have sufficient supplies to continue recruitment.
18) 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.
19) To liaise with the CTA to assist the Project Team in the production of Status Reports.
20) 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
21) Assist in submissions and notifications to Ethics Committees and Regulatory Authorities.
22) To serve as a mentor to less experienced In-House CRA staff.
23) To facilitate translation and back translation of all necessary documents, as appropriate for
local country requirements.
24) To attend, as needed, meetings (investigator, sponsor, kick-off, face-to-face) and to present at
25) Ensure compliance with Covance SOPs, and local regulatory authority regulations for clinical
conduct in all aspects of daily work.
26) Conduct site management activities, maintain site regulatory file, liaise with vendors; perform