Description

Premier Research is looking for a Clinical Research Associate to join our Clinical 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^SM. Join us and build your future here.

What you'll be doing:

• Delivers quality, timely monitoring reports for sponsor approval per the Clinical Monitoring Plan timelines
• Maintains submission of expenses according to travel and expense requirements within company guidelines
• Responsible for the validity, correctness, and completeness of the clinical data reviewed and collected at assigned sites as dictated by ICH GCP/ISO14155, protocol and client requirements
• Monitors (remote, onsite or other approved mode of monitoring) with a focus on data integrity and patient safety in accordance with specific country regulations
• Plans day to day activities for monitoring of a clinical study and sets priorities per site
• Prepares for and conducts on-site qualification, study initiation, interim monitoring and close-out monitoring visits at investigator sites as required by clinical monitoring plan.
• Takes the initiative to move the project/program forward by reducing backlog and keeping it at a minimum
• Monitors with knowledge of quality/scope/timeline and budget parameters
• Works with the Clinical Manager (CM), Clinical Lead or equivalent to enhance and proactively manage site visits and trial issues during the monitoring phase
• Monitors the quality of clinical deliverables and addresses quality issues with the appropriate team member. Escalates appropriately and in a timely manner to the appropriate team member.
• Manages query resolution process with sites and Premier Research Data Management
• Maintains Trial Master File (TMF)/electronic Trial Master File (eTMF) as defined by the organization’s processes per filing guidelines. Has an understanding of the required essential documents according to ICH/GCP Section 8. Reviews site documents and verifies they are accurate, complete, current, and include required updates.
• Assists project team with assessing project feasibility and recruitment, as applicable
• Maintains project tracking system of subjects and site information, as applicable
• Participates in Investigators’ Meeting as designated by the Project Manager
• Maintain communication with study sites as directed per CMP, and in agreement with the study site and complete documentation of contacts.
• Maintains proper, timely communication with study teams and management, as needed.
• Review of IP accountability and applicable logs (subject and site level) as directed per the Clinical Monitoring Plan
• Identifies confidential information and complies with global and local laws and guidelines
• In specific countries or situations, the CRA may be requested to also assume additional country specific responsibilities, being appointed as Subject Matter Expert in one or more areas including but not limited to the following: Start-up, Regulatory, Site Contracts, Office Manager, etc. This will be documented with the appropriate guidance or functional description
• Other activities as designated

What we are searching for:

• Undergraduate degree or its international equivalent in clinical, science, or health-related field from an accredited institution; a licensed health-care professional (i.e., registered nurse); or equivalent work experience required
• Previous clinical research experience required, along with completion of CRA training program and at least 1 and a half year of independent monitoring experience.
• Read, write and speak fluent English; fluent in host country language
• Experience in monitoring complex trials or global trials or equivalent experience
• Knowledge of ICH / GCP regulations
• Working knowledge of FDA Guidance Documents / EU Directives / local regulations / ISO14155 regulations, drug / device development, and clinical monitoring procedures
• Knowledge of web-based communication tools for conferences and any other IT systems required for the job
• Knowledge of clinical/health systems as well as knowledge of cultural/professional practices appropriate to the country/region where the site monitoring activities will be carried out
• Excellent team player, collaborative and able to enable an effective team
• Ability to multitask and work effectively in a fast-paced environment with changing priorities
• Strong verbal and written communication skills
• Excellent organizational and time-management skills, able to meet deadlines
• Self-starter with a lot of common sense and able to act on own initiative
• Accountable, dependable and strong commitment
• Travel: 70-85%
• Valid driver’s license, passport as required.

Why choose Premier Research?  

• Premier Research is more than a company – it’s a community of people that truly care about one another, about our clients, and about our mission of furthering research to improve the lives of patients in critical need.  
• Our cultural anchors – Caring & Empathy, Empowerment, Aspiration, One Team – mirror the 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 opportunities so that they have the tools they need to be successful.

Because we are transforming life-changing ideas into new medical treatments for a diverse population, we require the perspectives of a diverse staff thinking creatively, challenging ideas, and solving complex problems fearlessly. Through a commitment to diversity, equity, inclusion, and empowerment, we create a community of belonging that welcomes differences, fuels innovation, and better connects us to the patients, physicians, and customers we serve.

We hire people that add to our culture, then invest in developing skills and abilities. If you are excited about this role, but your past experiences do not perfectly align with the position as described, we encourage you to apply anyway. You may be exactly the right candidate for this role or others.

#LI-TB1   

Description

Premier Research is looking for a  Senior Clinical Research Associate to join our Clinical Monitoring team in North America. 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.

What you'll be doing:

• Perform monitoring activities (both on-site and remote) for Phase I-IV clinical trials, as well as device trials with opportunities to work in such therapeutic areas as: cardiovascular, oncology, pediatrics, rare disease, women’s health, dermatology, neurology, etc.  
• Ensure the validity, correctness, and completeness of clinical data collected at sites with a focus on data integrity and patient safety as dictated by trial protocol, ICH-GCP/ISO 141155, and customer requirements. 
• Serve as the primary point of contact for investigative sites, manage query resolution, support Trial Master File activities, participate in Investigators’ Meetings, and complete other project tasks in accordance with study timelines and budget. 
• Identify and escalate potential risks and possible retraining opportunities for investigative sites. 
• Schedule and plan day-to-day activities to include study monitoring visits, timely completion of high-quality trip reports, and active management of all deliverables.
• Regional travel 

What we are searching for:

• Bachelor’s degree, or local equivalent, in a clinical, biological, scientific, or health-related field or its international equivalent
• 4+ years of independent on-site monitoring experience with all types of site visits
• Completion of a CRA training program through a CRO
• You must live in United States 

Why choose Premier Research?

• Premier Research is more than a company – it’s a community of people that truly care about one another, about our clients, and about our mission of furthering research to improve the lives of patients in critical need. 
• Our cultural anchors – Caring & Empathy, Empowerment, Aspiration, One Team – mirror the 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 opportunities so that they have the tools they need to be successful.

Because we are transforming life-changing ideas into new medical treatments for a diverse population, we require the perspectives of a diverse staff thinking creatively, challenging ideas, and solving complex problems fearlessly. Through a commitment to diversity, equity, inclusion, and empowerment, we create a community of belonging that welcomes differences, fuels innovation, and better connects us to the patients, physicians, and customers we serve.

We hire people that add to our culture, then invest in developing skills and abilities. If you are excited about this role, but your past experiences do not perfectly align with the position as described, we encourage you to apply anyway. You may be exactly the right candidate for this role or others.

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.

#LI-CA1
#Remote

Description

Premier Research is looking for a  Senior Clinical Research Associate (Oncology) to join our Clinical Monitoring team in North America. 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.

• Perform a combination of remote and on-site monitoring activities for oncology clinical trials
• Ensure the validity, correctness, and completeness of clinical data collected at sites with a focus on data integrity and patient safety as dictated by trial protocol, ICH-GCP/ISO 141155, and customer requirements. 
• Serve as the primary point of contact for investigative sites, manage query resolution, support Trial Master File activities, participate in Investigators’ Meetings, and complete other project tasks in accordance with study timelines and budget. 
• Identify and escalate potential risks and possible retraining opportunities for investigative sites. 
• Schedule and plan day-to-day activities to include study monitoring visits, timely completion of high-quality trip reports, and active management of all deliverables.

What we are searching for:

• Bachelor’s degree, or local equivalent, in a clinical, biological, scientific, or health-related field or its international equivalent
• Must have Oncology experience (Phase I preferred)
• 4+ years of independent on-site monitoring experience with all types of site visits
• Completion of a CRA training program through a CRO

Why choose Premier Research?

• Premier Research is more than a company – it’s a community of people that truly care about one another, about our clients, and about our mission of furthering research to improve the lives of patients in critical need.
  
• Our cultural anchors – Caring & Empathy, Empowerment, Aspiration, One Team – mirror the 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 opportunities so that they have the tools they need to be successful.

Because we are transforming life-changing ideas into new medical treatments for a diverse population, we require the perspectives of a diverse staff thinking creatively, challenging ideas, and solving complex problems fearlessly. Through a commitment to diversity, equity, inclusion, and empowerment, we create a community of belonging that welcomes differences, fuels innovation, and better connects us to the patients, physicians, and customers we serve.

We hire people that add to our culture, then invest in developing skills and abilities. If you are excited about this role, but your past experiences do not perfectly align with the position as described, we encourage you to apply anyway. You may be exactly the right candidate for this role or others.

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.

#LI-CA1
#Remote