The Role
The Senior Clinical Research Associate monitors and manages clinical trials, ensuring compliance with protocols and regulations, while training site personnel and tracking investigational supplies.
Summary Generated by Built In
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
Except as otherwise permitted or required by applicable law or regulatory requirements, ProTrials will retain the applicant’s personal information in accordance with its statutory obligations and internal policies and procedures.
Information collected during application completion may be retained for a reasonable period of time and in accordance with the company’s established retention policies. Applicants seeking more information may contact [email protected].
ProTrials is an equal opportunity employer. ProTrials is committed to providing a workplace free from discrimination and harassment. All qualified candidates will receive equal consideration for employment without regard to race, color, citizenship status, national origin, ancestry, gender (including gender identity and gender expression), pregnancy, and childbirth or related medical conditions (including genetic characteristics), genetic information, sexual orientation, age, religion, creed, physical or mental disability, medical condition, military or veteran status, marital status, political affiliation, or any other characteristic protected by state or federal law.
Skills Required
- RN or Bachelor and/or advanced degree in biological sciences or related field
- Previous CRA experience demonstrating career growth
- Extensive knowledge of FDA regulations
- Excellent organizational skills and strong interpersonal skills
- Proficiency in Microsoft Word, Excel, and PowerPoint
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The Company
What We Do
ProTrials Research, Inc. is a mid-sized, full-service clinical research organization (CRO) founded in 1996. It partners with pharmaceutical, biotechnology, and medical device sponsors to provide clinical operations services, including study management, site monitoring, biometrics, and regulatory support. The company is a woman-owned business headquartered in Los Gatos, California, with a global reach, committed to delivering high-quality research to advance clinical trial success and improve patient health.
