Posted 1 month ago

Contract Senior Clinical Research Associate

RegionalRemoteContract

AI Summary

Contract Senior Clinical Research Associate who monitors and manages clinical trials, ensures protocol and regulatory compliance, trains site staff, reviews data and adverse events, and coordinates with sites and clients.

About this role

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

Skills

Case Report Form CompletionClinical Trial MonitoringFDA RegulationsICH-GCPInvestigational Product InventoryLaboratory Sample StorageMicrosoft ExcelMicrosoft PowerPointMicrosoft WordSite TrainingSource Data Verification

Contract Senior Clinical Research Associate

About this role

HERE IS WHAT YOU WILL DO:

HERE IS WHAT YOU BRING TO THE TABLE:

Skills

Explore related jobs

More jobs at ProTrials Research, Inc.

Similar Case Report Form Completion jobs

Browse these categories