Senior Clinical Research Monitor - Remote
Company: Vitalief Inc.
Posted on: November 25, 2022
Why Vitalief?Vitalief, a fast-growing, innovative Clinical Trial
Solutions Company, is committed to identifying talented and
passionate clinical research professionals to join our exceptional
team as experts and active members of our clients' research
Our PEOPLE FIRST culture prioritizes personal and professional
growth for OUR team. Although unconventional, we believe this is
the right approach to attract and retain top clinical research
talent. We offer the flexibility, growth, and professional support
that the highly competitive clinical research industry demands.
None of this is possible without the drive and passion of our
Vitalief team members. If you are interested in the clinical
research profession and being part of a culture that
- The ability to create and pursue multiple career paths
- Meaningful work in a flexible work environment
- An innovative culture that respects and encourages your
- Transparent leadership that invests in your career
- Variable incentive/reward system
- Mentor/mentee opportunities and support programs designed to
help you achieve your professional goals
Then we want to speak with you!
Note: Work is 100% remote in Texas
- Under the supervision of the Director, Protocol Support and
Management, you will be responsible for the review and evaluation
of multicenter clinical trial conduct, executing monitoring and
site management activities to ensure compliance to the protocol and
applicatory guidelines and regulations.
- Developing and maintaining collaborative study site
relationships to drive site performance and overall clinical trial
safety and success from site initiation, study start-up,
maintenance, and close-out.
- Participates in the development of and/or review of study
related documents (Protocol, Informed Consent, CRFs, Monitoring
- Conducts qualification, site initiation, routine monitoring,
and termination visits, performs data review and monitors data
quality. Generates reports summarizing findings to ensure timely
query and action item resolution.
- Mentors, coaches, and trains junior team members. Functions as
a resource for project team members.
- Generates and presents key metrics and reports to senior
management, ensuring project milestones are met.
- Exhibits core values of Caring, Integrity, and Discovery
- Minimum of 7 years of experience to include five years of
nursing and two years monitoring complex oncology trials.
- Bachelor's Degree in Nursing, Healthcare Administration or
related field required, Advanced degree preferred.
- Strong, in-depth knowledge of FDA regulations and ICH/CGP.
- Demonstrated ability to manage multiple multicenter
- Strong written and verbal communication skills; ability to
interact professionally and effectively communicate at all
- Working knowledge of EDC systems and CTMS preferred
- Proficiency with Microsoft Office suite
- Preferred certifications include: Advanced Oncology Certified
Nurse, Oncology Certified Nurse, Certified Clinical Research
Coordinator, Certified Clinical Research Associate, Certified
Clinical Research Professional, Regulatory Affairs
PHYSICAL DEMANDS: Standing, sitting, walking, and reaching.
Lifting, pushing and pulling up to 10lbs. Use of
IMPORTANT NOTE: Vitalief partners with clients such as major
medical centers and academic institutions that requires all on-site
resources such as prospective Vitalief consultants to provide proof
that they are fully vaccinated for Covid-19; inoculated annually
for Influenza; and successfully pass a Mantoux Tuberculin Skin Test
(TST) for Mycobacterium Tuberculosis.
Keywords: Vitalief Inc., Garland , Senior Clinical Research Monitor - Remote, Healthcare , Garland, Texas
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