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

Senior CRA - Client dedicated, Denmark

Laboratory Corporation of America Holdings (Covance)

Copenhagen, Denmark

<h2>Job Overview:</h2><p style="margin: 0px;"><span style="color: black; font-family: 'Verdana','sans-serif'; font-size: 9pt;">Labcorp Drug Development</span> is actively recruiting a <strong>Senior CRA in Denmark</strong>, ideally to be based in the <strong>Copenhagen</strong> area.  This is a full time <strong>Client Dedicated</strong> role so the selected candidate will only be working on studies from a single sponsor!</p><p style="margin: 0px;"> </p><p style="margin: 0px;"><span style="text-decoration: underline;"><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Key Duties:</span></span></p><p style="margin: 0px;"><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits, with or  without guidance; liaise with vendors; and other duties, as assigned</span></p><p style="margin: 0px;"> </p><p style="margin: 0px;"><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Responsible for aspects of registry management as prescribed in the project plans</span></p><p style="margin: 0px;"> </p><p style="margin: 0px;"><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">General  On-Site Monitoring  Responsibilities:</span></p><ul><li>Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study</li><li>Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements</li><li>Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review</li><li>Monitor data for missing or implausible data</li><li>Ensure the resources of the Sponsor and Covance are spent wisely by performing the required monitoring tasks in an efficient manner, according to SOPs and established guidelines, including managing travel expenses in an economical fashion according to Covance travel policy</li></ul><p style="margin: 0px;"><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">+   Travel, including air travel, may be required and is an essential function of the job.</span></p><p style="margin: 0px;"><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">+   Prepare  accurate and timely trip reports</span></p><p style="margin: 0px;">+   <span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Perform CRF 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</span><br />+   <span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Assist with the administration of clinical research projects, recruiting investigators, collecting investigator documentation and site management</span></p><p style="margin: 0px;"><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">+   Provide coverage for clinical contact telephone lines, as required</span></p><p style="margin: 0px;"><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">+   Update, track and maintain study-specific trial management tools/systems</span></p><p style="margin: 0px;"><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">+   Generate and track drug shipments  and supplies, as needed</span></p><p style="margin: 0px;"><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">+   Track and follow-up on serious adverse events as assigned</span></p><p style="margin: 0px;"><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">+   Implement  study-specific  communication  plan  as assigned</span></p><p style="margin: 0px;"><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">+   Attend investigators' meetings, project team meetings and teleconferences, as needed</span></p><p style="margin: 0px;"><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">+   Assist Senior CRA in managing investigator site budgets</span></p><p style="margin: 0px;"><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">+   Perform  other duties as assigned  by management</span></p><p style="margin: 0px;"> </p><p style="margin: 0px;"><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">For more information please contact Andy Smith on +44 (0)7775 848 250 or send your CV to andy.smith@covance.com</span></p><p style="margin: 0px;"> </p><p style="margin: 0px;"><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;"><span style="color: black; font-family: 'Verdana','sans-serif'; font-size: 9pt;">REMOTE</span></span></p><h2>Education/Qualifications:</h2><p style="margin: 0px;"><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure)</span></p><p style="margin: 0px;">and</p><p style="margin-top: 0.25pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">A minimum of 1-3 years on-site monitoring</span></p><p style="margin-top: 0.25pt;">Valid Driver's License</p><h2>Experience:</h2><ul><li>Field based, home office but willing to come into the Copenhagen office, when required</li><li>Previous monitoring experience in clinical trials, minimum 2 years</li><li>Proven skills in site management including site performance and patient recruitment</li><li>Excellent soft skills (include oral and written communication skills; computer literacy; works effectively in a matrix multicultural environment)</li><li>Good organizational and time management skills, able to work highly independently and be a team player</li><li>Flexibility, expected travelling 2-3 days/week</li><li>Customer focus and right mind-set to meet client’s needs and skills in building relationship with customer.</li><li>Ability to set up priorities and handle multiple tasks simultaneously in changing environment</li><li>Fluent in English (verbal and written)</li><li>Location strong preference near Copenhagen </li></ul>

Job posted: 2021-11-17

3