Senior Clinical Research Associate
ProTrials Research, Inc. · Oregon, United States
- Hybrid
- Contract
- $100,000 / year
- Oregon, United States
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Job highlights
- Monitor and manage clinical trials.
- Ensure protocol and regulatory compliance.
- Train and support site personnel.
- Manage investigational product and supplies.
- Review data and regulatory documentation.
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 Trial Monitoring
- ICH GCP
- FDA Regulations
- Site Management
- Data Management
- Investigational Product
- Regulatory Documentation
- Protocol Compliance
- Clinical Research
- Problem-Solving
Skills & topics
- Senior Clinical Research Associate
- Clinical Trials
- CRA
- CRO
- Clinical Monitoring
- ICH GCP
- FDA Regulations
- Pharmaceutical
- Biotech
- Medical Device
How to get hired
- Customize your resume: Highlight your RN or Bachelor's degree, clinical research experience, and knowledge of FDA regulations and ICH GCP.
- Tailor your application: Emphasize your detail-oriented nature, organizational skills, and problem-solving abilities in your cover letter.
- Showcase your expertise: Be ready to discuss your experience monitoring clinical studies, managing sites, and handling investigational products.
- Prepare for travel questions: Confirm your willingness and ability to travel up to 65%, including on short notice.
- Demonstrate technical skills: Be prepared to discuss your proficiency in Microsoft Word, Excel, and PowerPoint.
Technical preparation
Master ICH GCP guidelines thoroughly.,Review FDA regulations impacting trials.,Practice clinical trial monitoring techniques.,Familiarize with common CTMS software.
Behavioral questions
Describe a complex data discrepancy you resolved.,How do you handle changing priorities?,Share an experience training site staff.,How do you ensure regulatory compliance?
Frequently asked questions
- What is the primary responsibility of a Senior Clinical Research Associate at ProTrials Research?
- The primary responsibility of a Senior Clinical Research Associate (Sr. CRA) at ProTrials Research is to ensure clinical trials are conducted, recorded, and reported in accordance with the protocol, SOPs, ICH GCP, and all applicable regulatory requirements, playing an integral part in the successful monitoring and management of these trials.
- 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 an equivalent combination of experience and education. Previous CRA experience with demonstrated career growth is also crucial.
- Does the Senior Clinical Research Associate position at ProTrials Research require travel?
- Yes, the Senior Clinical Research Associate position may require travel up to 65%, including by air or car on short notice. This is a significant aspect of the role's responsibilities.
- What kind of training is involved for site personnel as part of the Sr. CRA role at ProTrials?
- As a Sr. CRA, you will manage and train site personnel on therapeutic area specifics, protocol requirements, proper source documentation, and case report form completion, ensuring sites are well-equipped to handle the trial.
- How does ProTrials Research support its employees in this Senior Clinical Research Associate role?
- ProTrials Research believes in supporting its team members by fostering a collaborative community where individuals feel valued and empowered. They focus on delivering high-quality, experienced, and ethical services.
- What technical skills are necessary for a Senior Clinical Research Associate at ProTrials Research?
- Proficiency in Microsoft Word, Excel, and PowerPoint is necessary for the Senior Clinical Research Associate role, alongside a strong understanding of clinical trial management and regulatory requirements.
- Can candidates with equivalent experience be considered for the Senior Clinical Research Associate role at ProTrials?
- Yes, ProTrials Research considers an equivalent combination of relevant experience, education, or training along with previous CRA experience demonstrating career growth as a valid qualification for the Senior Clinical Research Associate position.