Clinical Trial Assistant - South of England

<h2>Job Overview:</h2><p style="margin: 0px;"> </p><p style="margin: 0cm 0cm 0.0001pt; text-align: justify;"><span style="font-family: verdana, geneva; color: black; font-size: 10pt;">Exciting news for <span style="color: black; font-family: Verdana, sans-serif;">Labcorp Drug Development</span>, new Sponsor coming!</span></p><p style="margin: 0cm 0cm 0.0001pt; text-align: justify;"><span style="font-family: verdana, geneva; color: black; font-size: 10pt;"> </span></p><p style="margin: 0cm 0cm 0.0001pt; text-align: justify;"><span style="font-family: verdana, geneva; color: black; font-size: 10pt;">Across the globe, we keep our commitment to improve health and improve lives, and at Labcorp we are looking for exceptional people who are eager to play an important role pushing new frontiers in how we diagnose, monitor and treat patients. </span></p><p style="margin: 0cm 0cm 0.0001pt; text-align: justify;"><span style="font-family: verdana, geneva; color: black; font-size: 10pt;"> </span></p><p style="margin: 0cm 0cm 0.0001pt; text-align: justify;"><span style="font-family: verdana, geneva; color: black; font-size: 10pt;">Our Drug Development business continues to support and meet the needs of our pharmaceutical and biotechnology client partners: we continue to initiate new studies from Early Development through Phase IV, and our Central Labs are fully operational. </span></p><p style="margin: 0cm 0cm 0.0001pt; text-align: justify;"><span style="font-family: verdana, geneva; color: black; font-size: 10pt;"> </span></p><p style="margin: 0cm 1.7pt 0.0001pt 0cm; text-align: justify;"><span style="font-family: verdana, geneva; color: black; font-size: 10pt;">In this spirit, we would like to keep growing our relationship with talented CTAs across the UK.</span></p><p style="margin: 0cm 1.7pt 0.0001pt 0cm; text-align: justify;"><span style="font-family: verdana, geneva; font-size: 10pt;"> </span></p><p style="margin: 0px; text-align: justify;"><span style="font-family: verdana, geneva; font-size: 10pt;"><span style="font-family: Calibri, sans-serif;">Main responsibilities:</span></span></p><ul><li style="margin-top: 0cm; text-align: justify;"><span style="font-size: 10pt; font-family: verdana, geneva;">Participation in the completion of the RFPs in collaboration with the CPMs.</span></li><li style="margin-top: 0cm; text-align: justify;"><span style="font-size: 10pt; font-family: verdana, geneva;">Management of <u>study related payment procedures</u> with the dedicated Resource Administrator.</span></li><li style="margin-top: 0cm; text-align: justify;"><span style="font-size: 10pt; font-family: verdana, geneva;">Provision of input for budget development and <u>check of monthly costs</u> invoiced based on planned study activities vs actual, monthly check of the TTP received by the CRO in support to the CPM and support in all activities related to budget operations.</span></li><li style="margin-top: 0cm; text-align: justify;"><span style="font-family: verdana, geneva; font-size: 10pt;"><u>Preparation of study documentation</u> (<u>submission package to Regulatory Authorities and Ethics Committees</u>, study documents prepared through HERMES, review English texts and translations, CSR, publications) and support the CPM in ensuring the compliance of the clinical trial with SOPs and necessary standards.</span></li><li style="margin-top: 0cm; text-align: justify;"><span style="font-size: 10pt; font-family: verdana, geneva;">Support to the study team during internal audit and inspections</span></li><li style="margin-top: 0cm; text-align: justify;"><span style="font-size: 10pt; font-family: verdana, geneva;">Handling and maintenance of <u>paper/electronic TMF and electronic internal repository</u> according to ICH/GCP guidelines and European standards.</span></li><li style="margin-top: 0cm; text-align: justify;"><span style="font-size: 10pt; font-family: verdana, geneva;">Responsible for <u>paper/electronic TMF reconciliation</u> after study completion.</span></li><li style="margin-top: 0cm; text-align: justify;"><span style="font-size: 10pt; font-family: verdana, geneva;">Interaction with external providers during study conduct (CROs, monitors and, occasionally, with investigators and Hospital personnel).</span></li><li style="margin-top: 0cm; text-align: justify;"><span style="font-size: 10pt; font-family: verdana, geneva;">Collaboration with CPM, CTS Unit and QA in order to manage activities related to Clinical Trial Supplies: if required prepares and assembles labels, sends labels to CRO asking for certified translations in the applicable languages, prepares the CTS Request Form for validation by the CPM, validates the CTS reconciliation at the end of the study for the CPMs to authorise the destruction.</span></li><li style="margin-top: 0cm; text-align: justify;"><span style="font-family: verdana, geneva; font-size: 10pt;"><u>Organization of Kick-off Meetings, Study Design Meetings, and phone-conferences</u> with the CROs for the continuous update on clinical studies. May participate if required in the Investigator’s Meetings.</span></li><li style="margin-top: 0cm; text-align: justify;"><span style="font-family: verdana, geneva; font-size: 10pt;"><u>Assist the eCTD team</u> in the formatting of all documentation related to a clinical study, aimed at obtaining an electronic copy of the registration dossier.</span></li><li style="margin-top: 0cm; text-align: justify;"><span style="font-size: 10pt; font-family: verdana, geneva;">Review and management in the Dikesi system of no CROs contracts.</span></li><li style="margin-top: 0cm; text-align: justify;"><span style="font-family: verdana, geneva; font-size: 10pt;"><u>Preparation and maintenance of all trackers for the study conduction</u>, management of the study email Inbox, and support, if necessary, to the CPM in the One Data update.</span></li></ul><p style="margin: 0px;"> </p><h2>Education/Qualifications:</h2><ul><li style="text-align: justify;"><span style="font-size: 10pt; font-family: verdana, geneva;">Bachelor's degree or equivalent, preferably in life science, clinical re- search, or related discipline.</span></li><li style="text-align: justify;"><span style="font-size: 10pt; font-family: verdana, geneva;">Fluent level of English</span></li></ul><h2>Experience:</h2><ul><li><span style="font-family: verdana, geneva; font-size: 10pt;">University or college degree, or certification in Life sciences</span></li><li><span style="font-family: verdana, geneva; font-size: 10pt;">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></ul>