Merck Clinical Research Associate- Late Stage - Atlanta/ South Carolina (REMOTE) in Greenville, South Carolina
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.
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 withInternational Conference on 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
Coordinates and manages various tasks in collaboration with other sponsor roles to achieve Site Ready
Participates and 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 definedClinical Research Associate (CRA) Escalation Pathway as appropriate in collaboration with Clinical Research Manager (CRM), Partner Line Manager (PLM) and Regional Clinical Project Manager (RCPM)
CRA team knowledge by acting as process Subject Matter Expert (SME) , buddy/mentorand sharing best practices as appropriate/required
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, Supports and/or leads audit/inspection activities as needed
Education Minimum Requirements
- Bachelor Degree with strong emphasis in science and/or biology preferred
Required Experience and Skills
Minimum 2 years of direct site monitoring experience in a bio/pharma/Clinical Research Organization (CRO) or as country specifically requires
No compromise on minimum monitoring experience however specific experience requirements may vary depending on the Country
Ability to travel domestically and internationally approximately 65%-75% of working time
Expected travelling 2-3 days/week
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 …
Merck & Co., Inc., Kenilworth, New Jersey, USA is known as “Merck” in the United States, Canada & Puerto Rico. We are known as “MSD” in Europe, Middle East, Africa, Latin America & Asia Pacific. We are a global biopharmaceutical leader with a diverse portfolio of prescription medicines, oncology, vaccines and animal health products.
We are driven by our purpose to develop and deliver innovative products that save and improve lives. With 69,000 employees operating in more than 140 countries, we offer state of the art laboratories, plants and offices that are designed to Inspire our employees as we learn, develop and grow in our careers. We are proud of our 125 years of service to humanity and continue to be one of the world’s biggest investors in Research & Development.
What we look for …
In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth .
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Flexible Work Arrangements:
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Number of Openings:
Requisition ID: R22976
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