Senior Clinical Research Associate-Alabama (REMOTE)
Company: Merck & Co., Inc.
Posted on: November 22, 2021
New hires based in the US & Puerto Rico will be required to
demonstrate that they have been fully vaccinated for COVID-19 or
qualify for a medical or religious exemption or accommodation to
this vaccination requirement, subject to applicable law.
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.
Core tasks, including but not limited to, the following:
* 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 International Conference on Harmonization Good
Clinical Practice, Sponsor Standard Operating Procedures, Local
Laws & Regulations, Protocol, Site Monitoring Plan, and associated
* Gains an in-depth understanding of the study protocol and related
* Coordinates & manages various tasks in collaboration with other
sponsor roles to achieve Site Ready.
* Participates & provides inputs on site selection and validation
* Performs remote and on-site monitoring & oversight activities
using various tools to ensure:
* Data generated at the 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
* Identifies, assesses, and resolves site performance, quality, or
compliance problems, and escalates per defined Clinical Research
Associate Escalation Pathway as appropriate in collaboration with
Clinical Research Manager, Partner Line Manager, and Clinical
* Manages and maintains information and documentation in the
Clinical Trial Management System, electronic Trial Master File, and
various other systems as appropriate and per timelines.
* Contributes to Clinical Research Associate team knowledge by
acting as process Subject Matter Expert, buddy/mentor, and sharing
best practices as appropriate/required.
* Supports and/or leads audit/inspection activities as needed.
* Mentor/train other Clinical Research Associate team members
Education and Experience:
* B.A./B.S degree required; strong emphasis in science and/or
* Minimum of 4 years of direct site management (monitoring)
experience in a Bio/Pharma. / Clinical Research Organization.
* Ability to travel domestically and internationally approximately
65%-75% of working time.
Expected traveling 2-3 days/week.
* The current driver's license required.
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 International
Conference on Harmonization Good Clinical Practice (GCP/ICH) &
country clinical research law & guidelines.
* Excellent understanding of Global, Country/Regional Clinical
Research Guidelines, and ability to work within these
* 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
* Good IT skills (Use of MS office, use of various clinical IT
applications on the 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
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
* Works effectively in a matrix multicultural environment. Ability
to establish and maintain culturally sensitive working
* Works with high quality and compliance mindset
* Demonstrates commitment to Customer focus
* This is a remote-based position
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., Kenilworth, 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
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
EEOC GINA Supplement
OFCCP EEO 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.
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp &
Dohme Corp., Kenilworth, 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.
..... click apply for full job details
Keywords: Merck & Co., Inc., Montgomery , Senior Clinical Research Associate-Alabama (REMOTE), Healthcare , Montgomery, Alabama
Didn't find what you're looking for? Search again!