_:n5b38816364434a9bb5810fca57808ee6xb0
<http://schema.org/description>
"&lt;p style=\"text-align:left\"&gt;&lt;b&gt;Job Description&lt;/b&gt;&lt;/p&gt;&lt;p style=\"text-align:inherit\"&gt;&lt;/p&gt;&lt;p&gt;The role is accountable for performance and compliance for assigned protocols and sites in a country. &lt;br /&gt;Under the oversight of the CRA manager the person ensures compliance of study conduct with ICH/GCP and country regulations, our company&#39;s policies and procedures, quality standards and adverse event reporting requirements internally and externally.&lt;br /&gt;Acts as primary site contact and site manager throughout all phases of a clinical research study, &lt;br /&gt;taking overall responsibility of allocated sites.&lt;br /&gt;Actively develops and expands the territory for clinical research, finding and developing new sites. &lt;br /&gt;Participates in internal meetings and workstreams as SME for monitoring processes and systems.&lt;/p&gt;&lt;p style=\"text-align:inherit\"&gt;&lt;/p&gt;&lt;p style=\"text-align:left\"&gt;Current Employees apply &lt;a target=\"_blank\" href=\"https://wd5.myworkday.com/msd/d/task/1422$6687.htmld\"&gt;HERE&lt;/a&gt;&lt;/p&gt;&lt;p style=\"text-align:inherit\"&gt;&lt;/p&gt;&lt;p style=\"text-align:left\"&gt;Current Contingent Workers apply &lt;a target=\"_blank\" href=\"https://wd5.myworkday.com/msd/d/task/1422$4020.htmld\"&gt;HERE&lt;/a&gt;&lt;/p&gt;&lt;p style=\"text-align:inherit\"&gt;&lt;/p&gt;&lt;p style=\"text-align:left\"&gt;&lt;b&gt;Secondary&lt;/b&gt;&lt;b&gt; Language(s) Job Description:&lt;/b&gt;&lt;/p&gt;&lt;p style=\"text-align:inherit\"&gt;&lt;/p&gt;&lt;p style=\"text-align:inherit\"&gt;&lt;/p&gt;&lt;p&gt;Responsibilities include, but are not limited to: &lt;br /&gt;• Develops strong site relationships and ensures continuity of site relationships through all phases of the trial.&lt;br /&gt;• Performs clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws &amp; Regulations, Protocol, Site Monitoring Plan and associated documents. &lt;br /&gt;• Gains an in-depth understanding of the study protocol and related procedures.&lt;br /&gt;• Coordinates &amp; manages various tasks in collaboration with other sponsor roles to achieve Site Ready.&lt;br /&gt;• Participates &amp; provides inputs on site selection and validation activities.&lt;br /&gt;• Performs remote and on-site monitoring &amp; oversight activities using various tools to ensure:&lt;br /&gt;o Data generated at site are complete, accurate and unbiased.&lt;br /&gt;o Subjects’ right, safety and well-being are protected.&lt;br /&gt;• Conducts site visits including but not limited to validation visits, initiation visits, monitoring visits, close-out visits and records clear, comprehensive and accurate visit &amp; non-visit contact reports appropriately in a timely manner. &lt;br /&gt;• Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study close-out.&lt;br /&gt;• Communicates with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance.&lt;br /&gt;• Identifies, assesses and resolves site performance, quality or compliance problems and escalates per defined CRA Escalation Pathway as appropriate in collaboration with CRA Manager, CRM, TA Head and CRD as needed.&lt;br /&gt;• Works in partnership with GCTO country operations, finance, regulatory affairs, pharmacovigilance, legal and regional operations, HQ functional areas and externally with vendors and IRB/IECs and Regulatory Authorities in support of assigned sites.&lt;br /&gt;• Manages and maintains information and documentation in CTMS, eTMF and various other systems as appropriate and per timelines.&lt;br /&gt;• Contributes to CRA team knowledge by acting as process Subject Matter Expert (SME), buddy/mentor and sharing best practices as appropriate/required.&lt;br /&gt;• Supports and/or leads audit/inspection activities as needed.&lt;br /&gt;• Performs co-monitoring visits where appropriate.&lt;br /&gt;• Following the country strategy defined by CRD and/or CRA manager, contributes to the identification of new potential sites and works closely with them to develop strong clinical research capabilities.&lt;/p&gt;&lt;p&gt;&lt;/p&gt;&lt;p&gt;Required:&lt;br /&gt;• Min. 2 years of direct site management (monitoring) experience in a bio/pharma/CRO. &lt;/p&gt;&lt;p style=\"text-align:inherit\"&gt;&lt;/p&gt;&lt;p style=\"text-align:left\"&gt;&lt;b&gt;Search Firm Representatives Please Read Carefully &lt;/b&gt;&lt;br /&gt;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. &lt;/p&gt;&lt;p style=\"text-align:inherit\"&gt;&lt;/p&gt;&lt;p style=\"text-align:left\"&gt;&lt;b&gt;Employee Status: &lt;/b&gt;&lt;/p&gt;Regular&lt;p style=\"text-align:inherit\"&gt;&lt;/p&gt;&lt;p style=\"text-align:left\"&gt;&lt;b&gt;Relocation:&lt;/b&gt;&lt;/p&gt;No relocation&lt;p style=\"text-align:inherit\"&gt;&lt;/p&gt;&lt;p style=\"text-align:left\"&gt;&lt;b&gt;VISA Sponsorship:&lt;/b&gt;&lt;/p&gt;No&lt;p style=\"text-align:inherit\"&gt;&lt;/p&gt;&lt;p style=\"text-align:left\"&gt;&lt;b&gt;&lt;span&gt;Travel Requirements:&lt;/span&gt;&lt;/b&gt;&lt;/p&gt;75%&lt;p style=\"text-align:inherit\"&gt;&lt;/p&gt;&lt;p style=\"text-align:left\"&gt;&lt;b&gt;Flexible Work Arrangements:&lt;/b&gt;&lt;/p&gt;Hybrid&lt;p style=\"text-align:inherit\"&gt;&lt;/p&gt;&lt;p style=\"text-align:left\"&gt;&lt;b&gt;Shift:&lt;/b&gt;&lt;/p&gt;&lt;p style=\"text-align:inherit\"&gt;&lt;/p&gt;&lt;p style=\"text-align:left\"&gt;&lt;b&gt;Valid Driving License:&lt;/b&gt;&lt;/p&gt;Yes&lt;p style=\"text-align:inherit\"&gt;&lt;/p&gt;&lt;p style=\"text-align:left\"&gt;&lt;b&gt;Hazardous Material(s):&lt;/b&gt;&lt;/p&gt;&lt;p&gt;&lt;/p&gt;&lt;p&gt;&lt;b&gt;Job Posting End Date:&lt;/b&gt;&lt;/p&gt;11/30/2024&lt;p&gt;&lt;b&gt;&lt;span&gt;*A job posting is effective until 11:59:59PM on the day &lt;u&gt;BEFORE&lt;/u&gt; the listed job posting end date. Please ensure you apply to a job posting no later than the day &lt;u&gt;BEFORE&lt;/u&gt; the job posting end date. &lt;/span&gt;&lt;/b&gt;&lt;/p&gt;&lt;br&gt;&lt;p&gt;&lt;b&gt;Job Posting End Date:&lt;/b&gt;11/30/2024&lt;/p&gt;&lt;br&gt;&lt;p&gt;A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. &lt;/p&gt;&lt;br&gt;&lt;p&gt;&lt;b&gt;Requisition ID:&lt;/b&gt;R312775&lt;/p&gt;"
<https://jobs.msd.com/pt/pt/job/R312775/Clinical-Research-Associate>