Merck Senior Clinical Research Associate -NYC/NJ/CT (REMOTE) in Helena, Montana
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 are seeking a Growth and Improvement minded Senior Clinical Research Associate | NYC/NJ/CT that can help drive our Strategic Operating Priorities.
Invent | Pursue the Most Promising Internal and External Science to Address Significant Unmet Medical Needs
Execute | Prioritize Resources Behind Our Key Growth Drivers (Oncology, Vaccines, Select Specialty Areas, Animal Health) While Optimizing Our Base Business)
Adapt | Develop Our People, Culture and Business Model to Evolve with a Dynamic Landscape
Diverse Talent | We are committed to providing an inclusive and welcoming environment with supporting leadership behaviors because having a high-performing, engaged workforce is critical to our ability to deliver innovative solutions to patients and customers around the world
Values and Standards | Our Steadfast Commitment to Our Values and Standards will Continue to Guide Us as We Take on New Challenges and Will Always be Fundamental to Our Success – They are a Competitive Advantage for Us
Summary, Focus and Purpose
The role is accountable for performance and compliance for assigned protocols and sites in a country.
Under the oversight of the CRA manager the Senior CRA ensures compliance of study conduct with ICH/GCP and country regulations, company policies and procedures, quality standards and adverse event reporting requirements internally and externally.
You will be the primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility of allocated sites and will actively develop and expand the territory for clinical research, finding and developing new sites. Participates in internal meetings and workstreams as SME for monitoring processes and systems.
Work Independently and as a Team member with Integrity | Precision | Accomplishment | Motivational Ambition | Respect | Inclusion
Develops strong site relationships and ensures continuity of site relationships through all phases of the trial
Conducts 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 and manages various tasks in collaboration with other sponsor roles to achieve Site Ready
Participates and provides inputs on site selection and validation activities
Drives remote/on-site monitoring and 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 CRA Escalation Pathway as appropriate in collaboration with CRA Manager, CRM, TA Head and CRD
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
Manages and maintains information and documentation in CTMS, 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
Supports and/or leads audit/inspection activities
Completes co-monitoring visits
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
Mentors / buddies junior CRAs on process/study requirements and performs co-monitoring visits where appropriate
Quality control visits if delegated by other roles and trained appropriately
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
Understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH and country clinical research law and guidelines
Participatory knowledge of Good Documentation Practices
Proven Skills in Site Management including 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
Understand and analyze data/metrics and act appropriately
Capable of managing complex issues, works in a solution-oriented manner
Conducts root cause analysis and implements preventative and corrective action
Experience with conducting site motivational visit designed to boost site enrollment
Capable of mentoring junior CRAs on process/study requirements and is able to conduct co-monitoring visits where appropriate
Behavioral Competency Expectations
Effective time management, organizational and interpersonal skills, conflict management, problem solving skills
Demonstrated high level of monitoring skill with independent professional judgement
Work highly independently across multiple protocols, sites and therapy areas
High sense of accountability/urgency | Set priorities and handle multiple tasks simultaneously in a changing environment
Works effectively in a matrix multicultural environment
Establish and maintain culturally sensitive working relationships
Demonstrates commitment to Customer focus
Works with high quality and compliance mind-set
Positive mindset, growth mindset, capable of working independently and being self-driven
Demonstrates and projects professional demeanor and communication consistent with organizational policies and practices
Travel and Location Options
Domestically and internationally approximately 65%-75%
Expected travelling 2-3 days/week
New York City or New Jersey or Connecticut | Works Remote
- Bachelor of Arts or Science with strong emphasis in science and/or biology
- Four years direct site management (monitoring) in a bio/pharma/CRO
We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. 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.
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Requisition ID: R203884