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Assoc. Spclst, Clinical Research

Job DescriptionAn amazing opportunity has arisen under the oversight of the CRA-Manager, we're looking for an Assoc. Spclst, Clinical Research, will ensures the implementation of clinical trials in compliance with ICH/GCP, country laws and regulations, policies, procedures and quality standards.What you will do: Bring energy, knowledge, innovation and leadership to carry out the following:<ul><li>Acts as primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility of allocated sites.</li><li>Develops strong site relationships through all phases of the trial.</li><li>Performs clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents.</li><li>Participates and provides inputs on site selection and validation activities.</li><li>Performs remote and on-site monitoring and oversight activities using various tools to ensure patients' rights, safety and well-being are protected; data generated is complete, accurate and unbiased.</li><li>Conducts site visits, including but not limited, to validation, initiation, monitoring and close-out visits, recording clear, comprehensive and accurate visit & non-visit contact reports in a timely manner.</li><li>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.</li><li>Manages and maintains information and documentation in CTMS, eTMF and various other systems as appropriate and per timelines.</li></ul>What skills you will need: In order to excel in this role, you will more than likely have:<ul><li>Fluent in Portuguese and English (verbal and written) and excellent communication skills, including the ability to understand and present technical information effectively.</li><li>Good understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research law & guidelines.</li><li>Good IT skills (Use of MS office, use of various clinical IT applications on computer, tablet and mobile devices) and ability to adapt to new IT applications on various devices.</li><li>Ability to understand and analyse data/metrics and act appropriately.</li><li>Capable of managing complex issues and working in a solution-oriented manner.</li></ul>Why Join Us? As a company, we are committed to keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world’s most challenging healthcare needs. We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment.So, if you are ready to… please apply today.Required Skills: Accountability, Adverse Event Report, Clinical Evaluation Reports, Clinical Medicine, Clinical Research Methods, Clinical Sciences, Clinical Site Management, Clinical Study Management, Clinical Trial Planning, Clinical Trials, Clinical Trials Monitoring, Conflict Resolution, Data Analysis, Good Clinical Data Management Practice (GCDMP), Investigations Training, IS Audit, Key Stakeholder Relationships, Problem Solving, Protocol Adherence, Regulatory Compliance, Regulatory Documents, Root Cause Analysis (RCA), Site Selections, Solution-Oriented, Working IndependentlyPreferred Skills: Current Employees apply <a href="https://wd5.myworkday.com/msd/d/task/1422$6687.htmld" target="_blank" rel="noopener noreferrer">HERE</a>Current Contingent Workers apply <a href="https://wd5.myworkday.com/msd/d/task/1422$4020.htmld" target="_blank" rel="noopener noreferrer">HERE</a>Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & 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. Employee Status: RegularRelocation:VISA Sponsorship:Travel Requirements:Flexible Work Arrangements:RemoteShift:Valid Driving License:Hazardous Material(s):Job Posting End Date:06/2/2026*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.

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