This job posting may have expired!
Use our `search` to find similar offers.
Similar jobs

Senior In-house CRA

Laboratory Corporation of America Holdings (Covance)

Copenhagen, Denmark

<h2>Job Overview:</h2><p style="margin: 0px;"><span style="font-size: 10pt;">Covance by labcorp is looking to recruit <strong>Senior in house CRA</strong></span></p><p style="margin: 0px;"> </p><p style="margin: 0cm 1.7pt .0001pt 0cm;"><span style="font-size: 10pt; font-family: verdana, geneva;"><span style="color: #0a0a0a;"> </span><span style="color: #0a0a0a;">With all the uncertainty in the world, your job stability should not be a concern. </span></span></p><p style="margin: 0cm 1.7pt .0001pt 0cm;"><span style="font-size: 10pt; color: #0a0a0a; font-family: verdana, geneva;"> </span></p><p style="margin: 0cm 1.7pt .0001pt 0cm;"><span style="font-size: 10pt; color: #0a0a0a; font-family: verdana, geneva;">Covance by labcorp  have supported the pharmaceutical industry develop more medicines worldwide than any other company, including the top 50 best-selling drugs on the market today. But we are much more than a normal CRO:</span></p><p style="margin: 0cm 1.7pt .0001pt 0cm;"><span style="font-size: 10pt; color: #0a0a0a; font-family: verdana, geneva;"> </span></p><ul><li style="margin: 0cm 1.7pt .0001pt 36.0pt;"><span style="font-size: 10pt; color: #0a0a0a; font-family: verdana, geneva;">We are also the world´s biggest Central Lab, generating more clinical trial data than all other central laboratories combined</span></li><li style="margin: 0cm 1.7pt .0001pt 36.0pt;"><span style="font-size: 10pt; color: #0a0a0a; font-family: verdana, geneva;">Our Early Phase Solutions have proved to shave off 30 % time from lead candidate to Proof of Concept</span></li><li style="margin: 0cm 1.7pt .0001pt 36.0pt;"><span style="font-size: 10pt; color: black; font-family: verdana, geneva;">LabCorp/Covance were the first in receiving FDA approval to perform COVID19 tests using an at-home collection kit.</span></li></ul><p style="margin: 0cm 1.7pt .0001pt 0cm;"><span style="font-size: 10pt; color: #0a0a0a; font-family: verdana, geneva;"> </span></p><p style="margin: 0cm 1.7pt .0001pt 0cm;"><span style="font-size: 10pt; color: #0a0a0a; font-family: verdana, geneva;">Join us and see why Covance by labcorp  are uniquely positioned to offer you not only a job, but a stable, long-term international career, and why more than 90% of the top 20 global pharmaceutical companies are repeat customers.</span></p><p style="margin: 0cm 1.7pt .0001pt 0cm;"> </p><p style="margin: 0cm 1.7pt .0001pt 0cm;"><span style="font-size: 10pt;"><strong><span style="color: #0a0a0a; font-family: arial, helvetica, sans-serif;">Responsibilities : </span></strong></span></p><p style="margin: 0px;"> </p><p style="margin: 0px;"><span style="font-size: 10pt;">* 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></p><p style="margin: 0px;"><span style="font-size: 10pt;">* 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.</span></p><p style="margin: 0px;"><span style="font-size: 10pt;">* To monitor site performance and implement action plans for sites not meeting expectations, in conjunction with the CRA.</span></p><p style="margin: 0px;"><span style="font-size: 10pt;">* 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></p><p style="margin: 0px;"><span style="font-size: 10pt;">* Perform CRF review, query generation and resolution against established data review guidelines, Covance or client data management systems, as assigned by management</span></p><p style="margin: 0px;"><span style="font-size: 10pt;">* Might be requested to work in a client facing environment</span></p><p style="margin: 0px;"><span style="font-size: 10pt;">* General On-Site Monitoring Responsibilities: PSVs, SIVs, RMVs and COVs, and act as a co-monitor for on-site RMVs as needed.</span></p><p style="margin: 0px;"><span style="font-size: 10pt;">* Perform remote visits (i.e. Phone PSVs, Phone SIVs, remote RMVs, remote COVs) as required by the monitoring plan, including remote monitoring that includes SDV when sites provide remote access to their EMR.</span></p><p style="margin: 0px;"><span style="font-size: 10pt;">* General Monitoring Responsibilities: perform visits either as the primary monitor or the co-monitor as required by the monitoring plan including phone/remote or on-site: PSVs, SIVs, RMVs, COVs, others (e.g. motivation visits etc.)</span></p><p style="margin: 0px;"><span style="font-size: 10pt;">* 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></p><p style="margin: 0px;"><span style="font-size: 10pt;">* To provide site training as needed via phone or teleconference/web meeting.</span></p><p style="margin: 0px;"><span style="font-size: 10pt;">* To conduct IVRS/IWRS review and reconciliation, ensuring that data is accurate and up to date.</span></p><p style="margin: 0px;"><span style="font-size: 10pt;">* To liaise with sponsor/medical monitor regarding clinical questions and study status.</span></p><p style="margin: 0px;"><span style="font-size: 10pt;">* To assist with the coordination of study visits and shipment of drug and laboratory samples.</span></p><p style="margin: 0px;"><span style="font-size: 10pt;">* To manage sites to ensure subjects are complying with protocol requirements, study visits, and timelines.</span></p><p style="margin: 0px;"><span style="font-size: 10pt;">* 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.</span></p><p style="margin: 0px;"><span style="font-size: 10pt;">* 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></p><p style="margin: 0px;"><span style="font-size: 10pt;">* To liaise with the CTA to assist the Project Team in the production of Status Reports.</span></p><p style="margin: 0px;"><span style="font-size: 10pt;">* 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.</span></p><p style="margin: 0px;"><span style="font-size: 10pt;">* Assist in submissions and notifications to Ethics Committees and Regulatory Authorities.</span></p><p style="margin: 0px;"><span style="font-size: 10pt;">* To serve as a mentor to less experienced In-House CRA staff.</span></p><p style="margin: 0px;"><span style="font-size: 10pt;">* To facilitate translation and back translation of all necessary documents, as appropriate for local country requirements.</span></p><p style="margin: 0px;"><span style="font-size: 10pt;">* To attend, as needed, meetings (investigators, sponsor, kick-off, face-to-face) and to present at the meetings.</span></p><p style="margin: 0px;"><span style="font-size: 10pt;">* Ensure compliance with Covance SOPs, and local regulatory authority regulations for clinical conduct in all aspects of daily work.</span></p><p style="margin: 0px;"><span style="font-size: 10pt;">* Perform other duties as assigned by management.</span></p><h2>Education/Qualifications:</h2><ul><li><span style="font-size: 10pt; font-family: verdana, geneva; color: #333740;">University/college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology)</span></li><li style="margin-left: 0in;"><span style="font-size: 10pt; font-family: verdana, geneva; color: #333740;">Preferred candidates will have completed a year in industry during University studies or have relevant work experience in the clinical trial industry or related field (medical, clinical, pharmaceutical, laboratory, research, data analysis, data management or technical writing)</span></li></ul><h2>Experience:</h2><ul><li>A minimum of 2-4+ years of Clinical Monitoring experience as a CRA is preferred, or an<br />equivalent combination of education and experience to successfully perform the key<br />responsibilities of the job can be substituted.</li><li>Ability to monitor study sites independently according to protocol monitoring guidelines,<br />SOP, and local regulatory Guidelines</li><li>Have a full understanding of the Serious Adverse Event (SAE) reporting, process<br />production of reports, narratives and follow up of SAEs</li><li>Ability to work with minimal supervision</li><li>Good planning, organization and problem solving abilities</li><li>Good communication skills, oral and written</li><li>Good computer skills</li><li>Works efficiently and effectively in a matrix environment</li><li>Fluent in local official language and in English, both written and verbal</li></ul>

Job posted: 2021-03-15

3