Freelance Senior Clinical Research Associate - Belgium and The Netherlands

<p>For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality &amp; compliance, pharmacovigilance, medical information, and R&amp;D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs.</p><p></p><p></p><p><b>We have an immediate need for 2 SCRA's to join us on a Freelance basis in The Netherlands and covering both The Netherlands &amp; Belgium.</b></p><p></p><p>​The Senior Clinical Research Associate position is responsible for clinical monitoring for assigned protocols and investigational sites. The role is responsible for ensuring that studies are conducted and documented in accordance with the study protocol, standard operating procedures, Good Clinical Practices (GCP) and other applicable regulatory requirements.</p><ul><li><p><span><span>Responsible for conduct of all types of monitoring, and co-monitoring visits and associated monitoring activities for assigned clinical sites both in person, and remote.</span><span> This includes evaluation, site initiation, interim and close out </span><span>monitoring</span><span> visits. Responsible for monitoring report writing and completion within required SOP and local regulatory parameters. </span></span><span> </span></p></li></ul><ul><li><p><span><span>Ex-US</span><span>: May </span><span>be responsible for</span><span> performing study start up activities </span><span>in accordance with</span><span> local practice, including site identification and feasibility activities</span><span>, collection and preparation of site essential documents, Ethics Committee submissions, and other site set up activities.</span></span><span> </span></p></li></ul><ul><li><p><span><span>Support development of study specific documentation related to monitoring activities as assigned. This includes but is not limited to monitoring trackers, clinical monitoring guidelines, clinical monitoring plan, source document templates, site tools, and worksheets, etc. Responsible for site personnel management and training on the protocol requirements, proper source documentation procedures compliance, and case report completion requirements. </span></span><span> </span></p></li></ul><ul><li><p><span><span>Review</span><span> source document and case report forms </span><span>for</span><span> accuracy, completeness, and integrity of the data, and </span><span>identify</span><span> and resolv</span><span>e</span><span> ongoing data issues. </span></span><span> </span></p></li></ul><ul><li><p><span><span>Manag</span><span>e</span><span>, prepar</span><span>e</span><span>, send, track, and return investigational supplies as assigned. Includes monitoring and documenting investigational supplies dispensing, inventory, and <span><span>reconciliation. </span></span><span> </span></p></li></ul><ul><li><p><span><span>Monitor assigned clinical trials and clinical sites by reviewing and reporting site enrollment, and termination updates, monitoring visits, protocol deviations, serious adverse events, laboratory abnormalities and any other activity at the site that contributes to proper conduct of the clinical trial per protocol, and regulatory requirements. </span></span><span> </span></p></li></ul><ul><li><p><span><span>Review and overs</span><span>ee</span><span> regulatory documentations for accuracy</span><span> and</span><span> completeness and support assigned clinical sites with any regulatory concerns as </span><span>appropriate</span><span>. </span></span><span> </span></p></li></ul><ul><li><p><span><span>Communicate</span><span> with assigned clinical sites, investigators, site personnel, client personnel, and any other cross functional team member involved in the assigned clinical trials to address any study needs related to the monitoring and site management activities as assigned. </span></span><span> </span></p></li></ul><ul><li><p><span><span>Participate in meetings and conference calls with internal project teams, Sponsor teams, and any external partners working on execution of the assigned clinical trial.</span></span><span> </span></p></li></ul><ul><li><p><span><span>Other duties as assigned.</span></span><span> </span></p></li></ul><p></p><p><b><span>Necessary Skills</span><span> and A</span><span>bilities</span><span>:</span></b><span> </span></p><ul><li><p><span><span>Excellent verbal, written communication skills and interpersonal and presentation skills are </span><span>required</span><span>.</span></span><span> </span></p></li></ul><ul><li><p><span><