Senior Clinical Research Associate
ProTrials Research, Inc. · North Carolina, United States
- Hybrid
- Contract
- $100,000 / year
- North Carolina, United States
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Job highlights
- Monitor and manage clinical trials.
- Ensure compliance with regulations and protocols.
- Train and support site personnel.
- Review and resolve data discrepancies.
- Maintain study files and communication.
About the role
About ProTrials Research, Inc.
ProTrials is a women-owned, WBENC-certified Contract Research Organization (CRO) that has been a trusted partner in clinical research since 1996. Founded with a clear mission to deliver high-quality, experienced, and ethical services, we’ve supported research behind innovative treatments in the pharmaceutical, biotech, and medical device industries.
Our people are the heart of everything we do. We believe great work happens when team members feel valued, supported, and empowered. At ProTrials, you’ll join a collaborative community committed to making a meaningful impact on global health.
We are excited to connect with skilled individuals who share our passion for advancing clinical research with care, integrity, and excellence.
About the Job
ProTrials is seeking a Contract Senior Clinical Research Associate to join our team. The Contract Senior Clinical Research Associate (Sr. CRA) plays an integral part in the successful monitoring and management of clinical trials. Responsibilities of a Contract Sr. CRA include ensuring clinical trials are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), ICH GCP, and all applicable regulatory requirements. Contract Sr. CRAs may be required to travel up to 65%.
Here Is What You Will Do:
- Monitor clinical studies of investigational and approved products that have been determined to satisfy a medical need and/or offer a commercial benefit, including qualification, initiation, interim, and close-out site visits.
- Manage and train site personnel on therapeutic area, protocol requirements, proper source documentation, and case report form completion.
- Manage and track the preparation and return of investigational supplies at individual sites.
- Monitor and document investigational product dispensing, inventory, and reconciliation.
- Monitor and document laboratory sample storage and shipment.
- Monitor trial by reviewing and reporting on the following: site enrollment and termination updates, monitoring visits, protocol deviations/exceptions, serious adverse events, and laboratory abnormalities.
- Review source data and case report forms for accuracy, completeness, and integrity of the data, and identify and resolve ongoing data issues.
- Review data queries and listings, and work with study centers to resolve data discrepancies.
- Review regulatory documentation for accuracy and completeness, and support study centers with regulatory issues.
- Maintain complete and accurate study files and review files to ensure all appropriate documentation is present.
- Maintain consistent and timely contact with the study centers, investigators, coordinators, client personnel, and other individuals involved in clinical trials.
- Serve as a resource for project team members including supporting CRA I and CRA II staff by providing solutions to resolve issues.
Here Is What You Bring To The Table:
- RN or Bachelor and/or advanced degree in biological sciences or related field, or equivalent combination of relevant experience, education or training, and previous CRA experience demonstrating career growth in the CRA position.
- Detail-oriented.
- Excellent organizational skills, strong interpersonal and communications skills, and strong problem-solving skills.
- Flexibility with changing priorities.
- Ability to efficiently perform and prioritize multiple tasks.
- Familiarity with the medical and pharmaceutical industries, and related terminology and practices.
- Extensive knowledge of FDA regulations and their practical implementation.
- Ability to travel, including by air or by car on short notice.
- Proficiency in Microsoft Word, Excel, and PowerPoint.
Key skills/competency
- Clinical Research Associate
- Clinical Trials
- ICH GCP
- FDA Regulations
- Site Monitoring
- Data Management
- Regulatory Documentation
- Investigational Products
- Problem-Solving
- Communication Skills
Skills & topics
- Senior Clinical Research Associate
- Clinical Research
- CRA
- ICH GCP
- FDA Regulations
- Clinical Trials
- Site Monitoring
- Biotech
- Pharmaceutical
- Medical Device
- Healthcare
- CRO
- Data Integrity
- Regulatory Compliance
How to get hired
- Tailor your resume: Highlight your clinical research experience, adherence to regulations like ICH GCP and FDA, and specific monitoring skills.
- Showcase your qualifications: Emphasize your RN or Bachelor's degree, advanced degrees, and career growth as a CRA.
- Demonstrate key skills: Detail your organizational, communication, problem-solving, and travel flexibility in your application.
- Prepare for technical questions: Be ready to discuss your knowledge of FDA regulations and their practical implementation.
- Research ProTrials: Understand their mission, values, and history as a women-owned CRO to align your application.
Technical preparation
Master ICH GCP and FDA regulations.,Practice reviewing source data accuracy.,Familiarize with clinical trial protocols.,Enhance MS Office Suite skills.
Behavioral questions
Describe a complex data issue you resolved.,How do you manage conflicting priorities?,Share an experience training site personnel.,How do you ensure regulatory compliance?
Frequently asked questions
- What are the primary responsibilities of a Senior Clinical Research Associate at ProTrials Research?
- As a Senior Clinical Research Associate at ProTrials Research, you will be responsible for monitoring and managing clinical trials, ensuring compliance with protocols and regulations (ICH GCP, FDA), training site personnel, managing investigational supplies and data, and maintaining study documentation. You will also serve as a resource for other CRAs.
- What qualifications are essential for a Senior Clinical Research Associate role at ProTrials Research?
- Essential qualifications include an RN or Bachelor's/advanced degree in biological sciences or a related field, or equivalent experience. Significant previous CRA experience demonstrating career growth is crucial. Strong organizational, communication, problem-solving skills, and extensive knowledge of FDA regulations are also vital.
- Does the Senior Clinical Research Associate position at ProTrials Research require travel?
- Yes, the Senior Clinical Research Associate position requires travel up to 65%. This includes travel by air or car, potentially on short notice, to conduct site visits such as qualification, initiation, interim, and close-out.
- What kind of industries does ProTrials Research serve for its clinical trials?
- ProTrials Research serves the pharmaceutical, biotech, and medical device industries, supporting research for innovative treatments in these sectors.
- How does ProTrials Research support its team members in the Senior Clinical Research Associate role?
- ProTrials Research emphasizes a supportive and empowering work environment. They believe in valuing their team members and foster a collaborative community committed to advancing global health. You will join a team dedicated to making a meaningful impact.
- What specific software proficiencies are expected for a Senior Clinical Research Associate at ProTrials?
- Proficiency in Microsoft Word, Excel, and PowerPoint is required for the Senior Clinical Research Associate role at ProTrials Research. These tools are essential for data management, reporting, and communication.
- What is the typical career progression for a CRA at ProTrials Research?
- While this is a Senior CRA role, ProTrials values career growth. The job description mentions previous CRA experience demonstrating career growth, and Senior CRAs are expected to support CRA I and CRA II staff, suggesting opportunities for mentorship and leadership.