In-house CRA II

<h2>Job Overview:</h2><ul><li><span style="font-size: 12pt; font-family: calibri, sans-serif;">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</span></li><li><span style="font-size: 12pt; font-family: calibri, sans-serif;">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</span></li><li><span style="font-size: 12pt; font-family: calibri, sans-serif;">To monitor site performance and implement action plans for sites not meeting expectations, in conjunction with the CRA</span></li><li><span style="font-size: 12pt; font-family: calibri, sans-serif;">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)</span></li><li><span style="font-size: 12pt; font-family: calibri, sans-serif;">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.</span></li><li><span style="font-size: 12pt; font-family: calibri, sans-serif;">To perform Case Report Form review, query generation and resolution against established data review guidelines, on Covance or client data management systems, as assigned by management</span></li><li><span style="font-size: 12pt; font-family: calibri, sans-serif;">Might be requested to work in a client facing environment as assigned. </span></li><li><span style="font-size: 12pt; font-family: calibri, sans-serif;">General On-Site Monitoring Responsibilities: act as a co-monitor for on-site RMVs as needed </span></li><li><span style="font-size: 12pt; font-family: calibri, sans-serif;">Responsible for all aspects of remote visits with or without direct supervision (i.e. phone PSVs, phone SIVs, remote RMVs, remote COVs) as required by the monitoring plan. </span></li><li><span style="font-size: 12pt; font-family: calibri, sans-serif;">General Monitoring Responsibilities: perform visits per the monitoring plan to include those indicated in the chart below</span></li><li><span style="font-family: calibri, sans-serif; font-size: 12pt;">For visits that require direct supervision, the following staff is qualified to supervise the In-House CRA-II: Senior In-House Clinical Research Associate, Clinical Research Associate I (with 1+ years’ onsite monitoring experience), Clinical Research Associate 2, Sr. Clinical Research Associate 1, Sr. Clinical Research Associate 2, Clinical Trial Leads, Project Managers or Project Directors </span></li></ul><table style="width: 337.5pt; margin-left: .75in; border-collapse: collapse; border: none;" width="0"><tbody><tr><td style="width: 337.5pt; border: solid windowtext 1.0pt; padding: 0in 5.4pt 0in 5.4pt;" colspan="2" width="450"><p style="margin: 0px;"><span style="font-family: calibri, sans-serif; font-size: 12pt;"><strong>Onsite with Supervision</strong></span></p></td></tr><tr><td style="width: 312.45pt; border: solid windowtext 1.0pt; border-top: none; padding: 0in 5.4pt 0in 5.4pt;" width="417"><p style="margin: 0px;"><span style="font-size: 12pt; font-family: calibri, sans-serif;">PSV</span></p></td><td style="width: 25.05pt; border-top: none; border-left: none; border-bottom: solid windowtext 1.0pt; border-right: solid windowtext 1.0pt; padding: 0in 5.4pt 0in 5.4pt;" width="33"><p style="margin: 0px;"><span style="font-size: 12pt; font-family: calibri, sans-serif;">X</span></p></td></tr><tr><td style="width: 312.45pt; border: solid windowtext 1.0pt; border-top: none; padding: 0in 5.4pt 0in 5.4pt;" width="417"><p style="margin: 0px;"><span style="font-size: 12pt; font-family: calibri, sans-serif;">SIV</span></p></td><td style="width: 25.05pt; border-top: none; border-left: none; border-bottom: solid windowtext 1.0pt; border-right: solid windowtext 1.0pt; padding: 0in 5.4pt 0in 5.4pt;" width="33"><p style="margin: 0px;"><span style="font-size: 12pt; font-family: calibri, sans-serif;">X</span></p></td></tr><tr><td style="width: 312.45pt; border: solid windowtext 1.0pt; border-top: none; padding: 0in 5.4pt 0in 5.4pt;" width="417"><p style="margin: 0px;"><span style="font-size: 12pt; font-family: calibri, sans-serif;">RMV</span></p></td><td style="width: 25.05pt; border-top: none; border-left: none; border-bottom: solid windowtext 1.0pt; border-right: solid windowtext 1.0pt; padding: 0in 5.4pt 0in 5.4pt;" width="33"><p style="margin: 0px;"><span style="font-size: 12pt; font-family: calibri, sans-serif;">X</span></p></td></tr><tr><td style="width: 312.45pt; border: solid windowtext 1.0pt; border-top: none; padding: 0in 5.4pt 0in 5.4pt;" width="417"><p style="margin: 0px;"><span style="font-size: 12pt; font-family: calibri, sans-serif;">COV</span></p></td><td style="width: 25.05pt; border-top: none; border-left: none; border-bottom: solid windowtext 1.0pt; border-right: solid windowtext 1.0pt; padding: 0in 5.4pt 0in 5.4pt;" width="33"><p style="margin: 0px;"><span style="font-size: 12pt; font-family: calibri, sans-serif;">X</span></p></td></tr><tr><td style="width: 312.45pt; border: solid windowtext 1.0pt; border-top: none; padding: 0in 5.4pt 0in 5.4pt;" width="417"><p style="margin: 0px;"><span style="font-size: 12pt; font-family: calibri, sans-serif;">Other (motivational, observational and training  visits )</span></p></td><td style="width: 25.05pt; border-top: none; border-left: none; border-bottom: solid windowtext 1.0pt; border-right: solid windowtext 1.0pt; padding: 0in 5.4pt 0in 5.4pt;" width="33"><p style="margin: 0px;"><span style="font-size: 12pt; font-family: calibri, sans-serif;">X</span></p></td></tr><tr><td style="width: 337.5pt; border: solid windowtext 1.0pt; border-top: none; padding: 0in 5.4pt 0in 5.4pt;" colspan="2" width="450"><p style="margin: 0px;"><span style="font-family: calibri, sans-serif; font-size: 12pt;"><strong>Onsite without Supervision</strong></span></p></td></tr><tr><td style="width: 312.45pt; border: solid windowtext 1.0pt; border-top: none; padding: 0in 5.4pt 0in 5.4pt;" width="417"><p style="margin: 0px;"><span style="font-size: 12pt; font-family: calibri, sans-serif;">PSV</span></p></td><td style="width: 25.05pt; border-top: none; border-left: none; border-bottom: solid windowtext 1.0pt; border-right: solid windowtext 1.0pt; padding: 0in 5.4pt 0in 5.4pt;" width="33"><p style="margin: 0px;"><span style="font-size: 12pt; font-family: calibri, sans-serif;"> </span></p></td></tr><tr><td style="width: 312.45pt; border: solid windowtext 1.0pt; border-top: none; padding: 0in 5.4pt 0in 5.4pt;" width="417"><p style="margin: 0px;"><span style="font-size: 12pt; font-family: calibri, sans-serif;">SIV</span></p></td><td style="width: 25.05pt; border-top: none; border-left: none; border-bottom: solid windowtext 1.0pt; border-right: solid windowtext 1.0pt; padding: 0in 5.4pt 0in 5.4pt;" width="33"><p style="margin: 0px;"><span style="font-size: 12pt; font-family: calibri, sans-serif;"> </span></p></td></tr><tr><td style="width: 312.45pt; border: solid windowtext 1.0pt; border-top: none; padding: 0in 5.4pt 0in 5.4pt;" width="417"><p style="margin: 0px;"><span style="font-size: 12pt; font-family: calibri, sans-serif;">RMV</span></p></td><td style="width: 25.05pt; border-top: none; border-left: none; border-bottom: solid windowtext 1.0pt; border-right: solid windowtext 1.0pt; padding: 0in 5.4pt 0in 5.4pt;" width="33"><p style="margin: 0px;"><span style="font-size: 12pt; font-family: calibri, sans-serif;"> </span></p></td></tr><tr><td style="width: 312.45pt; border: solid windowtext 1.0pt; border-top: none; padding: 0in 5.4pt 0in 5.4pt;" width="417"><p style="margin: 0px;"><span style="font-size: 12pt; font-family: calibri, sans-serif;">COV</span></p></td><td style="width: 25.05pt; border-top: none; border-left: none; border-bottom: solid windowtext 1.0pt; border-right: solid windowtext 1.0pt; padding: 0in 5.4pt 0in 5.4pt;" width="33"><p style="margin: 0px;"><span style="font-size: 12pt; font-family: calibri, sans-serif;"> </span></p></td></tr><tr><td style="width: 312.45pt; border: solid windowtext 1.0pt; border-top: none; padding: 0in 5.4pt 0in 5.4pt;" width="417"><p style="margin: 0px;"><span style="font-size: 12pt; font-family: calibri, sans-serif;">Other (motivational, observational and training  visits)</span></p></td><td style="width: 25.05pt; border-top: none; border-left: none; border-bottom: solid windowtext 1.0pt; border-right: solid windowtext 1.0pt; padding: 0in 5.4pt 0in 5.4pt;" width="33"><p style="margin: 0px;"><span style="font-size: 12pt; font-family: calibri, sans-serif;">X</span></p></td></tr><tr><td style="width: 337.5pt; border: solid windowtext 1.0pt; border-top: none; padding: 0in 5.4pt 0in 5.4pt;" colspan="2" width="450"><p style="margin: 0px;"><span style="font-family: calibri, sans-serif; font-size: 12pt;"><strong>Remote</strong></span></p></td></tr><tr><td style="width: 312.45pt; border: solid windowtext 1.0pt; border-top: none; padding: 0in 5.4pt 0in 5.4pt;" width="417"><p style="margin: 0px;"><span style="font-size: 12pt; font-family: calibri, sans-serif;">PSV</span></p></td><td style="width: 25.05pt; border-top: none; border-left: none; border-bottom: solid windowtext 1.0pt; border-right: solid windowtext 1.0pt; padding: 0in 5.4pt 0in 5.4pt;" width="33"><p style="margin: 0px;"><span style="font-size: 12pt; font-family: calibri, sans-serif;">X</span></p></td></tr><tr><td style="width: 312.45pt; border: solid windowtext 1.0pt; border-top: none; padding: 0in 5.4pt 0in 5.4pt;" width="417"><p style="margin: 0px;"><span style="font-size: 12pt; font-family: calibri, sans-serif;">SIV</span></p></td><td style="width: 25.05pt; border-top: none; border-left: none; border-bottom: solid windowtext 1.0pt; border-right: solid windowtext 1.0pt; padding: 0in 5.4pt 0in 5.4pt;" width="33"><p style="margin: 0px;"><span style="font-size: 12pt; font-family: calibri, sans-serif;">X</span></p></td></tr><tr><td style="width: 312.45pt; border: solid windowtext 1.0pt; border-top: none; padding: 0in 5.4pt 0in 5.4pt;" width="417"><p style="margin: 0px;"><span style="font-size: 12pt; font-family: calibri, sans-serif;">RMV</span></p></td><td style="width: 25.05pt; border-top: none; border-left: none; border-bottom: solid windowtext 1.0pt; border-right: solid windowtext 1.0pt; padding: 0in 5.4pt 0in 5.4pt;" width="33"><p style="margin: 0px;"><span style="font-size: 12pt; font-family: calibri, sans-serif;">X</span></p></td></tr><tr><td style="width: 312.45pt; border: solid windowtext 1.0pt; border-top: none; padding: 0in 5.4pt 0in 5.4pt;" width="417"><p style="margin: 0px;"><span style="font-size: 12pt; font-family: calibri, sans-serif;">RMV with remote SDV/SDR</span></p></td><td style="width: 25.05pt; border-top: none; border-left: none; border-bottom: solid windowtext 1.0pt; border-right: solid windowtext 1.0pt; padding: 0in 5.4pt 0in 5.4pt;" width="33"><p style="margin: 0px;"><span style="font-size: 12pt; font-family: calibri, sans-serif;">X</span></p></td></tr><tr><td style="width: 312.45pt; border: solid windowtext 1.0pt; border-top: none; padding: 0in 5.4pt 0in 5.4pt;" width="417"><p style="margin: 0px;"><span style="font-size: 12pt; font-family: calibri, sans-serif;">COV</span></p></td><td style="width: 25.05pt; border-top: none; border-left: none; border-bottom: solid windowtext 1.0pt; border-right: solid windowtext 1.0pt; padding: 0in 5.4pt 0in 5.4pt;" width="33"><p style="margin: 0px;"><span style="font-size: 12pt; font-family: calibri, sans-serif;">X</span></p></td></tr><tr><td style="width: 312.45pt; border: solid windowtext 1.0pt; border-top: none; padding: 0in 5.4pt 0in 5.4pt;" width="417"><p style="margin: 0px;"><span style="font-size: 12pt; font-family: calibri, sans-serif;">Other (motivational, observational and training  visits )</span></p></td><td style="width: 25.05pt; border-top: none; border-left: none; border-bottom: solid windowtext 1.0pt; border-right: solid windowtext 1.0pt; padding: 0in 5.4pt 0in 5.4pt;" width="33"><p style="margin: 0px;"><span style="font-size: 12pt; font-family: calibri, sans-serif;">X</span></p></td></tr></tbody></table><ul><li><span style="font-size: 12pt; font-family: calibri, sans-serif;">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.</span></li><li><span style="font-size: 12pt; font-family: calibri, sans-serif;">To provide site training as needed via phone or teleconference/web meeting</span></li><li><span style="font-size: 12pt; font-family: calibri, sans-serif;">To conduct IVRS/IWRS review and reconciliation, ensuring that data is accurate and up to date</span></li><li><span style="font-size: 12pt; font-family: calibri, sans-serif;">To liaise with sponsor/medical monitor regarding clinical questions and study status</span></li><li><span style="font-size: 12pt; font-family: calibri, sans-serif;">To assist with the coordination of study visits and shipment of drug and laboratory samples</span></li><li><span style="font-size: 12pt; font-family: calibri, sans-serif;">To manage sites to ensure subjects are complying with protocol requirements, study visits, and timelines</span></li><li><span style="font-size: 12pt; font-family: calibri, sans-serif;">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</span></li><li><span style="font-size: 12pt; font-family: calibri, sans-serif;">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</span></li><li><span style="font-size: 12pt; font-family: calibri, sans-serif;">To liaise with the CTA to assist the project team in the production of status reports</span></li><li><span style="font-size: 12pt; font-family: calibri, sans-serif;">To work in a timely manner in accordance with all the activities specified in the agreed study budget, under the minimal supervision and guidance of the Clinical Team Leader (CTL) and Project Manager</span></li><li><span style="font-size: 12pt; font-family: calibri, sans-serif;">Assist in submissions and notifications to Ethics Committees and Regulatory Authorities, as applicable in region</span></li><li><span style="font-size: 12pt; font-family: calibri, sans-serif;">General On-Site Monitoring Responsibilities: assist MEA CRAIs, Senior IHCRAs and CRAs, with on-site tasks as required and according to training goals (e.g. review of Case Report Forms, SDV/SDR, Site Regulatory File and drug accountability)</span></li><li><span style="font-size: 12pt; font-family: calibri, sans-serif;">To facilitate translation and back translation of all necessary documents, as appropriate for local country requirements, as needed regionally</span></li><li><span style="font-size: 12pt; font-family: calibri, sans-serif;">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</span></li><li><span style="font-size: 12pt; font-family: calibri, sans-serif;">To attend, as needed, meetings (investigator, sponsor, kick-off, face-to-face) and to present at the meetings</span></li><li><span style="font-size: 12pt; font-family: calibri, sans-serif;">Ensure compliance with Covance SOPs, and local regulatory authority regulations for clinical conduct in all aspects of daily work</span></li><li><span style="font-family: calibri, sans-serif; font-size: 12pt;">To perform other duties as assigned by management per the monitoring plan to include those indicated in the chart below.</span></li></ul><table style="width: 319.5pt; margin-left: 58.25pt; border-collapse: collapse; border: none;" width="0"><tbody><tr><td style="width: 4.0in; border: solid windowtext 1.0pt; padding: 0in 5.4pt 0in 5.4pt;" width="384"><p style="margin: 0px;"><span style="font-size: 12pt; font-family: calibri, sans-serif;">Essential doc collection</span></p></td><td style="width: 31.5pt; border: solid windowtext 1.0pt; border-left: none; padding: 0in 5.4pt 0in 5.4pt;" width="42"><p style="margin: 0px;"><span style="font-size: 12pt; font-family: calibri, sans-serif;">X</span></p></td></tr><tr><td style="width: 4.0in; border: solid windowtext 1.0pt; border-top: none; padding: 0in 5.4pt 0in 5.4pt;" width="384"><p style="margin: 0px;"><span style="font-size: 12pt; font-family: calibri, sans-serif;">Essential doc review</span></p></td><td style="width: 31.5pt; border-top: none; border-left: none; border-bottom: solid windowtext 1.0pt; border-right: solid windowtext 1.0pt; padding: 0in 5.4pt 0in 5.4pt;" width="42"><p style="margin: 0px;"><span style="font-size: 12pt; font-family: calibri, sans-serif;">X</span></p></td></tr><tr><td style="width: 4.0in; border: solid windowtext 1.0pt; border-top: none; padding: 0in 5.4pt 0in 5.4pt;" width="384"><p style="margin: 0px;"><span style="font-size: 12pt; font-family: calibri, sans-serif;">Contact for study teams</span></p></td><td style="width: 31.5pt; border-top: none; border-left: none; border-bottom: solid windowtext 1.0pt; border-right: solid windowtext 1.0pt; padding: 0in 5.4pt 0in 5.4pt;" width="42"><p style="margin: 0px;"><span style="font-size: 12pt; font-family: calibri, sans-serif;">X</span></p></td></tr><tr><td style="width: 4.0in; border: solid windowtext 1.0pt; border-top: none; padding: 0in 5.4pt 0in 5.4pt;" width="384"><p style="margin: 0px;"><span style="font-size: 12pt; font-family: calibri, sans-serif;">Manage subject screening/enrollment</span></p></td><td style="width: 31.5pt; border-top: none; border-left: none; border-bottom: solid windowtext 1.0pt; border-right: solid windowtext 1.0pt; padding: 0in 5.4pt 0in 5.4pt;" width="42"><p style="margin: 0px;"><span style="font-size: 12pt; font-family: calibri, sans-serif;">X</span></p></td></tr><tr><td style="width: 4.0in; border: solid windowtext 1.0pt; border-top: none; padding: 0in 5.4pt 0in 5.4pt;" width="384"><p style="margin: 0px;"><span style="font-size: 12pt; font-family: calibri, sans-serif;">In-house site management</span></p></td><td style="width: 31.5pt; border-top: none; border-left: none; border-bottom: solid windowtext 1.0pt; border-right: solid windowtext 1.0pt; padding: 0in 5.4pt 0in 5.4pt;" width="42"><p style="margin: 0px;"><span style="font-size: 12pt; font-family: calibri, sans-serif;">X</span></p></td></tr><tr><td style="width: 4.0in; border: solid windowtext 1.0pt; border-top: none; padding: 0in 5.4pt 0in 5.4pt;" width="384"><p style="margin: 0px;"><span style="font-size: 12pt; font-family: calibri, sans-serif;">Review study data (eCRF)</span></p></td><td style="width: 31.5pt; border-top: none; border-left: none; border-bottom: solid windowtext 1.0pt; border-right: solid windowtext 1.0pt; padding: 0in 5.4pt 0in 5.4pt;" width="42"><p style="margin: 0px;"><span style="font-size: 12pt; font-family: calibri, sans-serif;">X</span></p></td></tr><tr><td style="width: 4.0in; border: solid windowtext 1.0pt; border-top: none; padding: 0in 5.4pt 0in 5.4pt;" width="384"><p style="margin: 0px;"><span style="font-size: 12pt; font-family: calibri, sans-serif;">Submission/Renewal to IRB-IEC (as needed per country)</span></p></td><td style="width: 31.5pt; border-top: none; border-left: none; border-bottom: solid windowtext 1.0pt; border-right: solid windowtext 1.0pt; padding: 0in 5.4pt 0in 5.4pt;" width="42"><p style="margin: 0px;"><span style="font-size: 12pt; font-family: calibri, sans-serif;">X</span></p></td></tr><tr><td style="width: 4.0in; border: solid windowtext 1.0pt; border-top: none; padding: 0in 5.4pt 0in 5.4pt;" width="384"><p style="margin: 0px;"><span style="font-size: 12pt; font-family: calibri, sans-serif;">Conduct Site training</span></p></td><td style="width: 31.5pt; border-top: none; border-left: none; border-bottom: solid windowtext 1.0pt; border-right: solid windowtext 1.0pt; padding: 0in 5.4pt 0in 5.4pt;" width="42"><p style="margin: 0px;"><span style="font-size: 12pt; font-family: calibri, sans-serif;">X</span></p></td></tr><tr><td style="width: 4.0in; border: solid windowtext 1.0pt; border-top: none; padding: 0in 5.4pt 0in 5.4pt;" width="384"><p style="margin: 0px;"><span style="font-size: 12pt; font-family: calibri, sans-serif;">Regular telephone contact with Sites</span></p></td><td style="width: 31.5pt; border-top: none; border-left: none; border-bottom: solid windowtext 1.0pt; border-right: solid windowtext 1.0pt; padding: 0in 5.4pt 0in 5.4pt;" width="42"><p style="margin: 0px;"><span style="font-size: 12pt; font-family: calibri, sans-serif;">X</span></p></td></tr><tr><td style="width: 4.0in; border: solid windowtext 1.0pt; border-top: none; padding: 0in 5.4pt 0in 5.4pt;" width="384"><p style="margin: 0px;"><span style="font-size: 12pt; font-family: calibri, sans-serif;">Documentation of site contacts</span></p></td><td style="width: 31.5pt; border-top: none; border-left: none; border-bottom: solid windowtext 1.0pt; border-right: solid windowtext 1.0pt; padding: 0in 5.4pt 0in 5.4pt;" width="42"><p style="margin: 0px;"><span style="font-size: 12pt; font-family: calibri, sans-serif;">X</span></p></td></tr><tr><td style="width: 4.0in; border: solid windowtext 1.0pt; border-top: none; padding: 0in 5.4pt 0in 5.4pt;" width="384"><p style="margin: 0px;"><span style="font-size: 12pt; font-family: calibri, sans-serif;">Assist with preparation of Site Visits</span></p></td><td style="width: 31.5pt; border-top: none; border-left: none; border-bottom: solid windowtext 1.0pt; border-right: solid windowtext 1.0pt; padding: 0in 5.4pt 0in 5.4pt;" width="42"><p style="margin: 0px;"><span style="font-size: 12pt; font-family: calibri, sans-serif;">X</span></p></td></tr></tbody></table><h2>Education/Qualifications:</h2><p style="margin: 0px;"><span style="font-family: calibri, sans-serif; font-size: 12pt;"><strong>Minimum Required:</strong></span></p><ul><li><span style="font-size: 12pt; font-family: calibri, sans-serif;">University or college degree (biological or life science preferred), or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure, medical or laboratory technology)</span></li></ul><p style="margin-right: 8.65pt;"><span style="font-size: 12pt; font-family: calibri, sans-serif;"> </span><span style="font-size: 12pt; font-family: calibri, sans-serif;">AND</span></p><ul><li><span style="font-size: 12pt; font-family: calibri, sans-serif;">A minimum of 2 years of experience in a related role (e.g. site management, in-house CRA, study coordinator, research nurse, etc.)</span></li><li><span style="font-size: 12pt; font-family: calibri, sans-serif;">Basic understanding of ICH Guidelines and GCP including a basic understanding of regulatory requirements</span></li><li><span style="font-size: 12pt; font-family: calibri, sans-serif;">Basic understanding of the clinical trial process</span></li><li><span style="font-size: 12pt; font-family: calibri, sans-serif;">Valid Driver’s License</span></li></ul><h2>Experience:</h2><p style="margin-top: 3.65pt;"><span style="font-family: calibri, sans-serif; font-size: 12pt;"><strong>Minimum Required:</strong></span></p><ul><li><span style="font-size: 12pt; font-family: calibri, sans-serif;">University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure)</span></li></ul><p style="margin: 0px;"><span style="font-size: 12pt; font-family: calibri, sans-serif;">AND</span></p><ul><li><span style="font-size: 12pt; font-family: calibri, sans-serif;">a minimum of 2 years of industry experience in a related role (e.g. site management, in-house CRA, study coordinator, research nurse, etc.)</span></li><li><span style="font-size: 12pt; font-family: calibri, sans-serif;">Ability to monitor study sites according to protocol monitoring guidelines, SOPs, ICH Guidelines and GCP</span></li><li><span style="font-size: 12pt; font-family: calibri, sans-serif;">Ability to work within a project team</span></li><li><span style="font-size: 12pt; font-family: calibri, sans-serif;">Good planning, organization and problem solving abilities</span></li><li><span style="font-size: 12pt; font-family: calibri, sans-serif;">Good communication skills, oral and written</span></li><li><span style="font-size: 12pt; font-family: calibri, sans-serif;">Good computer skills</span></li><li><span style="font-size: 12pt; font-family: calibri, sans-serif;">Works efficiently and effectively in a matrix environment</span></li><li><span style="font-size: 12pt; font-family: calibri, sans-serif;">Fluent in local official language and in English, both written and verbal</span></li></ul><p style="margin: 0px;"><span style="font-family: calibri, sans-serif; font-size: 12pt;"><strong>Preferred:</strong></span></p><ul><li><span style="font-size: 12pt; font-family: calibri, sans-serif;">One (1) or more additional years of experience in a related field with research experience (i.e., medical, clinical, pharmaceutical laboratory, research, data analysis, data management or technical writing) is preferred.</span></li></ul>