Job Description: We are a global health care leader with a diversified portfolio of prescription medicines, vaccines, and animal health products.
The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where our company has codified its 125-year legacy.
Our company's success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.
Our company is on a quest for cures and is committed to being the world's premier, most research-intensive biopharmaceutical company.
Today, we're doubling down on this goal.
Our research division is a true scientific research facility of tomorrow and will take our leading discovery capabilities and world-class small molecule and biologics R&D expertise to create breakthrough science that radically changes the way we approach serious diseases.
The role is accountable for performance and compliance for assigned protocols and sites in a country.
With support of Senior CRA and/or CRA Manager, acts as primary site contact and site manager throughout all phases of a clinical research study, taking responsibility of allocated sites.
Responsibilities: 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 to ensure:Data generated at site are complete, accurate, and unbiased.Subjects' rights, 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 as needed.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.Supports audit/inspection activities as needed.Performs co-monitoring where appropriate. Requirements: Master in Science (or comparable).
Advanced degree (MD, PhD) possible but not required.Strong communication, educational/pedagogic, diplomatic and empathic skills.Strong organizational skills with demonstrated success required.Native Spanish and fluent English.Problem-solving and conflict resolution skills.Negotiation skills with both internal and external groups.Good understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research law & guidelines.Good understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines.Hands-on 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.Ability to understand and analyze data/metrics and act appropriately. 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.
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