Associate Clinical Research Associate - West Region (CO, NV) - Remote
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.
With support of Sr. CRA/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.
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 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.
Fluent in Local Languages and English (verbal and written) and excellent communication skills, including the ability to understand technical information. Developing ability to present technical information with support.
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 CRA Guidelines and ability to work within these guidelines.
Hands on knowledge of Good Documentation Practices
Developing skills in Site Management including management of site performance and patient recruitment
Developing level of monitoring skill and independent professional judgment.
Good IT skills (Use of MS office, use of some clinical IT applications on computer, tablet and mobile devices) and ability to adapt to new IT applications on various devices.
Works with high quality and compliance mindset.
Capable of managing complex issues, solution-oriented approach.
Ability to perform root cause analysis and implement preventative and corrective action.
Behavioral Competency Expectations:
Effective time management, organizational and interpersonal skills, conflict management
Able to work with other experienced research professions to develop skills 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, with support from Line Manager.
Works effectively in a matrix multicultural environment. Ability to establish and maintain culturally sensitive working relationships.
Demonstrates commitment to Customer focus.
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.
Education and Experience
B.A./B.S. required with strong emphasis in science and/or biology.
Min. 2 years of clinical research experience. Related CR experience may include Clinical Trial Assistant, Study Coordinator, Regulatory CTC or similar.
Extent of Travel
Ability to travel domestically and internationally approximately 65%-75% of working time.
Expected travelling ~2-3 days/week.
Current driver’s license preferred.
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.
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
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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.
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Expected salary range:$72,880.00 - $114,600.00
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Flexible Work Arrangements:Remote Work
Valid Driving License:No