Senior Clinical Research Associate - WA, OR, NV, CA (REMOTE)

Merck Remote
senior clinical research research remote research clinical research management monitoring medical manager protocol collaboration separation
January 19, 2023
Merck
Montgomery, Alabama
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 Senior 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. Acts as primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility of allocated sites. Develops strong site relationships and ensures continuity of site relationships through all phases of the trial. Performs clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents. Gains an in-depth understanding of the study protocol and related procedures. Coordinates & manages various tasks in collaboration with other sponsor roles to achieve Site Ready. Participates & provides inputs on site selection and validation activities. Performs remote and on-site monitoring & oversight activities using various tools to ensure: Data generated at site are complete, accurate and unbiased Subjects' right, safety and well-being are protected Conducts site visits including but not limited to validation visits, initiation visits, monitoring visits, close-out visits and records clear, comprehensive and accurate visit & non-visit contact reports appropriately in a timely manner. Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study close-out. 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 Escalation Pathway as appropriate in collaboration with Clinical Research Manager, Partner Line Manager and Regional Clinical Project Manager. Manages and maintains information and documentation in Clinical Trial Management System, electronic Trial Master File and various other systems as appropriate and per timelines. Contributes strongly to Clinical Research Associate team knowledge by acting as process Subject Matter Expert (SME), sharing best practices, making recommendations for continuous improvement and providing training as appropriate/required. Supports and/or leads audit/inspection activities as needed. Mentors / buddies junior Clinical Research Associates on process/study requirements and performs co-monitoring visits where appropriate Education and Experience: B.A./B.S. preferred with strong emphasis in science and/or biology 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 65%-75% of working time. Expected travelling 2-3 days/week. Current driver's license preferred. 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 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 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 MRLGCTO #EligibleforERP We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we "follow the science" and that great medicines can make a significant impact to our world. And we believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe. Who we are ... We are known as Merck & Co., Inc., Rahway, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world. What we look for ... Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us-and start making your impact today. 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 separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor. Residents of Colorado Click here (~~~) to request this role's pay range. For positions located in the United States and Puerto Rico - Subject to applicable law, all new hires (including internal transfers) must demonstrate that they are fully vaccinated against COVID-19 or that they qualify for a medical or religious exemption to this vaccination requirement. New hires (including internal transfers) to a position that, as determined by the Company, requires routine collaboration with external stakeholders (such as roles in health services or customer-facing commercial or research-based roles) ("Customer-Facing Role") who are not vaccinated must qualify for a medical or religious exemption and be in a position that the Company determines can accommodate unvaccinated employees without causing an undue burden to business operations. If, following dialog with the candidate as appropriate, it is determined that the candidate either a) does not qualify for a religious or medical exemption or, b) for candidates applying for Customer-Facing roles, it is determined that allowing the candidate to work without vaccination would cause an undue burden to the Company, the candidate will be ineligible for hire or transfer, or any offer of employment or transfer (if applicable) will be revoked. Please note that notwithstanding the approval of any reasonable accommodation, the Company reserves the right to monitor, modify, or revoke any such accommodation if it is determined, following dialog with the employee, that the accommodation is no longer effective or results in an undue burden to the Company. Current Employees apply HERE (~~~) Current Contingent Workers apply HERE (~~~) US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here (~~~) if you need an accommodation during the application or hiring process. For more information about personal rights under Equal Employment Opportunity, visit: EEOC Know Your Rights (~~~) EEOC GINA Supplement? Pay Transparency Nondiscrimination (~~~) 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. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace. Under New York City, Washington State and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate's relevant skills, experience, and education. Expected salary range: $118,640.00 - $186,800.00 For Washington State Jobs, a summary of benefits is listed here (~~~/) . Learn more about your rights, including under California, Colorado and other US State Acts (~~~/) 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: Regular Relocation: No relocation VISA Sponsorship: No Travel Requirements: 50% Flexible Work Arrangements: Remote Work Shift: 1st - Day Valid Driving License: Yes Hazardous Material(s): No Number of Openings: 1 Requisition ID: R221374

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