Senior Clinical Research Associate

<p>Job Description</p><p></p><ul><li><p><span>Join a multi-award-winning leading biopharmaceutical company</span></p></li><li><p><span>Be part of growing team of Clinical Research Associates </span></p></li><li><p><span>Use new technology and smart monitoring tools </span></p></li><li><p><span>Have flexibility of work and good work-life balance</span></p></li></ul><p></p><p><b>Apply today!</b></p><p></p><p>On this position you will be accountable for performance and compliance for assigned protocols and sites in a country. You will act as primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility of allocated sites and actively develop and expand the territory for clinical research, finding and developing new sites.</p><p></p><p><b>Your key responsibilities:</b></p><ul><li><p><span>Conduct site visits (validation visits, initiation visits, monitoring visits, close-out visits) and record clear, comprehensive and accurate visit &amp; non-visit contact reports.</span></p></li><li><p><span>Ensure by monitoring activities that: </span></p><ul><li><p><span>Data generated at site are complete, accurate and unbiased.</span></p></li><li><p><span>Subjects' right, safety and well-being are protected.</span></p></li></ul></li><li><p><span>Perform clinical study site <span>management/monitoring</span> activities in compliance with local regulations, ICH-GCP, Sponsor SOPs, protocol, Site Monitoring Plan and associated documents.</span></p></li><li><p><span>Coordinate and manage various tasks in collaboration with other sponsor roles.</span></p></li><li><p><span>Communicate with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance.</span></p></li><li><p><span>Identify and assess site performance, quality or compliance problems in collaboration with CRA Manager, Project Manager, Therapeutical Area Head and Country Director as needed.</span></p></li><li><p><span>Manage and maintain clinical trial systems such as CTMS, eTMF, etc. </span></p></li><li><p><span>Share the knowledge and best practices, nurture a learning culture to boost efficiency and competence of our team.</span></p></li><li><p><span>Follow the country strategy defined by Country Director.</span></p></li></ul><p><span> </span></p><p><b>You should apply if you have:</b></p><ul><li><p><span>Min. 3 years</span><span> of direct site management (monitoring) experience in a bio/pharma/CRO.</span></p></li><li><p><span>Proven skills in site management, including management of site performance and patient recruitment.</span></p></li><li><p><span>Good IT skills, ability to learn and operate new IT applications. </span></p></li><li><p><span>Ability to understand and analyse data/metrics. </span></p></li><li><p><span>Capable of managing complex issues, works in a solution-oriented manner.</span></p></li><li><p><span>Fluent in English (verbal and written) and local language, excellent communication and presentation skills.</span></p></li><li><p><span>Good understanding and working knowledge of clinical research, local regulations, ICH-GCP.</span></p></li><li><p><span>M.A/ M.Sc degree with strong emphasis in medical/bioscience background.</span></p></li><li><p><span>Ability to travel domestically and internationally approximately 50% of working time. Expected travelling ~2-3 days/week.</span></p></li><li><p><span>Valid driving license.</span></p></li></ul><p></p><p>Current Employees apply <a href="https://wd5.myworkday.com/msd/d/task/1422$6687.htmld" rel="noopener noreferrer" target="_blank">HERE</a></p><p></p><p>Current Contingent Workers apply <a href="https://wd5.myworkday.com/msd/d/task/1422$4020.htmld" rel="noopener noreferrer" target="_blank">HERE</a></p><p></p><p><b>Search Firm Representatives Please Read Carefully </b><br/>Merck &amp; Co., Inc., Rahway, NJ, USA, also known as Merck Sharp &amp; Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. </p><p></p><p><b>Employee Status: </b></p>Regular<p></p><p><b>Relocation:</b></p><p></p><p><b>VISA Sponsorship:</b></p><p></p><p><b><span>Travel Requirements:</span></b></p><p></p><p><b>Flexible Work Arrangements:</b></p>Remote<p></p><p><b>Shift:</b></p><p></p><p><b>Valid Driving License:</b></p><p></p><p><b>Hazardous Material(s):</b></p><p></p><p><b>Required Skills:</b></p>Accountability, Accountability, Adaptability, Adverse