Job Description

Senior Clinical Research Associate- Validation - Arizona (REMOTE) at Merck in Boise, Idaho, United States Job Description Job Description Our Clinical and Pharmacovigilance teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs, vaccines, and new indications for existing products. We ensure we conduct high-quality clinical trials by integrating state-of-the-art technology and applying rigorous scientific and ethical standards. We care deeply about helping the world be well. We strive to improve health for others in the future by developing new drugs and vaccines that treat and prevent disease. Clinical trials are an essential part of this process. The Clinical Research Associate role is integral to helping the world meet new breakthroughs that affect generations to come, and we're counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. Our Clinical Research and Pharmacovigilance team push the boundaries of global healthcare through research and innovation. Through clinical trials and surveillance, we ensure the safety and efficacy of our existing and pipeline products to produce safe, effective, innovative medicine. Core tasks, including but not limited to, the following: The role is accountable for site selection of assigned protocols in a team environment and sites in a country. Under the oversight of the CRA manager the person ensures compliance of study conduct with ICH/GCP and country regulations, our company's policies and procedures, quality standards and adverse event reporting requirements internally and externally. Acts as primary site contact and site manager through site selection. Actively develops and expands the territory for clinical research, finding and developing new sites. Participates in internal meetings and workstreams as SME for monitoring processes and systems. Primary Responsibilities + Conducts site selection visits and feasibility assessments for trials in all Therapeutic areas. + Acts as primary site contact during site selection + Develops strong site relationships and ensures continuity of site relationships + Performs clinical study site management/monitoring activities in compliance with International Council for Harmonisation Good Clinical Practice (ICH-GCP), Sponsor Standard Operating Procedures (SOPs), Local Laws & Regulations, Protocol, Site Monitoring Plan, and associated documents. + Gains an in-depth understanding of the study protocol and related procedures to have robust discussions with site investigator and site staff about recruitment capabilities. + Participates and provides inputs on site selection and validation activities. + Conducts site validation visits and records clear, comprehensive, and accurate visit reports appropriately in a timely manner. + 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. + Identifies, assesses, and resolves site performance, quality, or compliance problems and escalates per defined Clinical Research Associate (CRA) Escalation Pathway as appropriate in collaboration with Clinical Research Manager (CRM), Partner Line Manager (PLM) and Regional Clinical Project Manager (RCPM). + Manages and maintains information and documentation in Clinical Trial Management System (CTMS), Trial Master File (eTMF) and various other systems as appropriate and per timelines. + Contributes to CRA team knowledge by acting as process Subject Matter Expert (SME), buddy/mentor and sharing best practices as appropriate/required. Education and Experience: + B.A./B.S degree required; strong emphasis in science and/or biology preferred + Minimum of 4 years of direct site management (monitoring) experience in a Bio/Pharma. / Clinical Research Organization. Travel Expectations: + Ability to travel domestically and internationally approximately 60% of working time. Expected traveling 2-3 days/week. + Current driver's license required. Core Competency Expectations: + Fluent in Local Languages and English (verbal and written) and excellent communication skills, including the ability to understand and present technical information effectively. + Excellent understanding and working knowledge of clinical research, phases of clinical trials, current International Conference on Harmonization Good Clinical Practice (GCP/ICH) & country clinical research law & guidelines. + Excellent understanding of Global, Country/Regional Clinical Research Guidelines, and ability to work within these guidelines. + Demonstrated ability to mentor/lead + Hands-on knowledge of Good Documentation Practices + Proven Skills in Site Management including independent management of site performance and patient recruitment + Demonstrated high level of monitoring skill with independent professional judgment. + Good IT skills (Use of MS office, use of various clinical IT applications on the computer, tablet, and mobile devices) and ability to adapt to new IT applications on various devices. + Ability to understand and analyze data/metrics and act appropriately Behavioral Competency Expectations: + Effective time management, organizational and interpersonal skills, conflict management, problem-solving skills + Able to work highly independently across multiple protocols, sites and therapy areas + High sense of accountability/urgency. Ability to set priorities and handle multiple tasks simultaneously in a changing environment + Works effectively in a matrix multicultural environment. Ability to establish and maintain culturally sensitive working relationships + Works with high quality and compliance mindset + Demonstrates commitment to Customer focus NOTICE FOR INTERNAL APPLICANTS In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions. If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separationpackage, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor. Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission. Current Employees apply HERE (Current Contingent Workers apply HER To view full details and how to apply, please login or create a Job Seeker account

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