Senior Clinical Research Associate (FSP, Phase I)
remote type
Remote
locations
United States of America
time type
Full time
posted on
Posted 3 Days Ago
job requisition id
R5412
Premier Research is looking for a Senior Clinical Research Associate (FSP, Phase I) to join our Functional Services Provider (FSP) team.
You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success.
We are Built for You. We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires.
We are Built by You. Your ideas influence the way we work, and your voice matters here.
We are Built with You. As an essential part of our team, you help us deliver the medical innovation that patients are desperate for.
Together, we are Built for Biotech. Join us and build your future here.
What you'll be doing:
Conducts source verification by comparing data recorded on Case Report Forms against source documents, verifying Informed Consent Forms for accuracy and completeness, and reviewing regulatory documents and device accountability records
Issues, investigates, and resolves any data discrepancies identified during source verification activities
Ensures clear written communication to clinical sites and project team members through monitoring reports, follow-up letters, study memos, and general correspondence.
Maintains thorough documentation and proper escalation of issues related to visit reports.
Ensures any identified non-compliance issues are addressed, clearly communicated, documented and escalated as required through monitoring visits, analyzing study metrics, and general study data overview.
Participates in study-specific meetings, teleconferences and trainings.
Manages study contracts, requests/collects relevant investigator/site documentation (i.e. regulatory documents, financial disclosure forms, curriculum vitae/medical license), and reviews and approves documents in applicable database.
Who we are searching for:
Bachelor degree, or international equivalent from an accredited institution, preferably in a clinical, biological, scientific, or health-related field or equivalent combination of education, training and experience
5 to 7 years of practical experience conducting continuous independent onsite monitoring of clinical research sites as well as site management activities.
Experience with monitoring Phase I and Neuroscience studies highly preferred
Experience with a sponsor-embedded (FSP) model prioritized
Proven ability to drive a successful customer experience through positive customer interactions, provision of quality and timely deliverables, and task ownership
Strong analytical and organization skills, able to work independently and manage multiple projects simultaneously in a fast-paced environment with changing priorities
Travel: 70-85% nationally, must be able to meet 10 days on site per month
Central USA locations preferred
Premier Research is dedicated to providing compensation that is fair and competitive with market standards. The annualized starting base pay for this role is $105,000.00 USD. The actual salary will be influenced based on a variety of factors such as the candidate's qualifications, skills, competencies, and proficiency for the role. We also offer a comprehensive benefits package, which may include health insurance, retirement plans, and paid time off.
Premier Research is proud to be an equal opportunity employer that is compliant with all federal guidelines. All qualified applicants will receive equitable consideration without regard to race, color, religion, sexual orientation, gender identity, national origin, disability or veteran status
Why Choose Premier?
Premier Research is more than a company - it's a community furthering research to improve the lives of patients in critical need. We are a diverse staff thinking creatively, challenging ideas, and solving complex problems.
Our Values - We Aim High, We Work Together, We Stay Agile, We Get It Done, We Care - mirror the determination, flexibility and trust that our team embodies.
As a Premier team member, you have the power to make an impact, regardless of job title and location.
Our dedication to biotech and specialty pharma is unlike any other.
We provide our staff with innovative technologies and continuous learning.
Join Our Network
Introduce yourself to our Talent Team and we will reach out if there is a role that aligns with your experience and interests.
Get Started
About Us
Premier Research is a global clinical research, product development, and consulting company. We are dedicated to helping biotech, specialty pharma, and MedTech innovators transform life-changing ideas and breakthrough science into new medical treatments. Our team is inspired by this common purpose. Premier is a place where you can change lives, and feel rewarded and celebrated. We aim high - we will not stop until we reach our goals. And we care about each other, about our customer and partners, and, most importantly, about all the patients that we touch with our work.
remote type
Remote
locations
United States of America
time type
Full time
posted on
Posted 3 Days Ago
job requisition id
R5412
Premier Research is looking for a Senior Clinical Research Associate (FSP, Phase I) to join our Functional Services Provider (FSP) team.
You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success.
We are Built for You. We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires.
We are Built by You. Your ideas influence the way we work, and your voice matters here.
We are Built with You. As an essential part of our team, you help us deliver the medical innovation that patients are desperate for.
Together, we are Built for Biotech. Join us and build your future here.
What you'll be doing:
Conducts source verification by comparing data recorded on Case Report Forms against source documents, verifying Informed Consent Forms for accuracy and completeness, and reviewing regulatory documents and device accountability records
Issues, investigates, and resolves any data discrepancies identified during source verification activities
Ensures clear written communication to clinical sites and project team members through monitoring reports, follow-up letters, study memos, and general correspondence.
Maintains thorough documentation and proper escalation of issues related to visit reports.
Ensures any identified non-compliance issues are addressed, clearly communicated, documented and escalated as required through monitoring visits, analyzing study metrics, and general study data overview.
Participates in study-specific meetings, teleconferences and trainings.
Manages study contracts, requests/collects relevant investigator/site documentation (i.e. regulatory documents, financial disclosure forms, curriculum vitae/medical license), and reviews and approves documents in applicable database.
Who we are searching for:
Bachelor degree, or international equivalent from an accredited institution, preferably in a clinical, biological, scientific, or health-related field or equivalent combination of education, training and experience
5 to 7 years of practical experience conducting continuous independent onsite monitoring of clinical research sites as well as site management activities.
Experience with monitoring Phase I and Neuroscience studies highly preferred
Experience with a sponsor-embedded (FSP) model prioritized
Proven ability to drive a successful customer experience through positive customer interactions, provision of quality and timely deliverables, and task ownership
Strong analytical and organization skills, able to work independently and manage multiple projects simultaneously in a fast-paced environment with changing priorities
Travel: 70-85% nationally, must be able to meet 10 days on site per month
Central USA locations preferred
Premier Research is dedicated to providing compensation that is fair and competitive with market standards. The annualized starting base pay for this role is $105,000.00 USD. The actual salary will be influenced based on a variety of factors such as the candidate's qualifications, skills, competencies, and proficiency for the role. We also offer a comprehensive benefits package, which may include health insurance, retirement plans, and paid time off.
Premier Research is proud to be an equal opportunity employer that is compliant with all federal guidelines. All qualified applicants will receive equitable consideration without regard to race, color, religion, sexual orientation, gender identity, national origin, disability or veteran status
Why Choose Premier?
Premier Research is more than a company - it's a community furthering research to improve the lives of patients in critical need. We are a diverse staff thinking creatively, challenging ideas, and solving complex problems.
Our Values - We Aim High, We Work Together, We Stay Agile, We Get It Done, We Care - mirror the determination, flexibility and trust that our team embodies.
As a Premier team member, you have the power to make an impact, regardless of job title and location.
Our dedication to biotech and specialty pharma is unlike any other.
We provide our staff with innovative technologies and continuous learning.
Join Our Network
Introduce yourself to our Talent Team and we will reach out if there is a role that aligns with your experience and interests.
Get Started
About Us
Premier Research is a global clinical research, product development, and consulting company. We are dedicated to helping biotech, specialty pharma, and MedTech innovators transform life-changing ideas and breakthrough science into new medical treatments. Our team is inspired by this common purpose. Premier is a place where you can change lives, and feel rewarded and celebrated. We aim high - we will not stop until we reach our goals. And we care about each other, about our customer and partners, and, most importantly, about all the patients that we touch with our work.
Job ID: 484253568
Originally Posted on: 7/6/2025
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