Clinical Research Associate (Spanish Speaking)
Location: United States (Chicago, IL or Dallas, TX)
Employment Type: Full-Time
Job Requisition ID: JR 8264
Work Model: Remote with significant travel
Posted: Recently
About ProPharma
For over 20 years, ProPharma has partnered with biotechnology, pharmaceutical, and medical device organizations worldwide to advance scientific innovation and improve patient outcomes. Through its integrated advise–build–operate model, ProPharma delivers end-to-end solutions across regulatory sciences, clinical research, quality and compliance, pharmacovigilance, medical information, and R&D technology, supporting clients throughout the full product lifecycle.
Position Overview
The Clinical Research Associate (CRA) plays a critical role in the execution and oversight of clinical trials in accordance with study protocols, ICH-GCP guidelines, and regulatory requirements. This position is responsible for site management activities, monitoring clinical trial performance, and maintaining strong relationships with investigators and site staff. The role supports both in-house and outsourced studies and requires fluency in Spanish and English.
The CRA must be based in Chicago, IL or Dallas, TX and is expected to travel extensively to support assigned clinical sites.
Key Responsibilities
Clinical Trial Monitoring and Site Management
Serve as the primary point of contact between the sponsor and assigned clinical trial sites.
Conduct site qualification, initiation, routine monitoring, oversight, and close-out visits in accordance with the Monitoring Plan.
Ensure clinical trial conduct complies with protocol requirements, ICH-GCP guidelines, SOPs, and applicable regulatory requirements.
Monitor subject enrollment, data quality, protocol adherence, and site performance metrics.
Perform source data verification, resolve data queries, and ensure accurate and timely data entry into EDC systems.
Communication and Collaboration
Maintain consistent communication with investigators, study coordinators, and site staff to ensure alignment with study milestones and expectations.
Facilitate effective communication between clinical sites and cross-functional project teams.
Deliver site training on protocols, regulatory requirements, GCP, and study-specific procedures.
Participate in investigator meetings, study team meetings, and study-related teleconferences.
Compliance, Documentation, and Reporting
Ensure accurate documentation of monitoring activities, including visit reports, follow-up letters, and site communications.
Identify, document, and escalate serious issues, risks, or non-compliance in a timely manner.
Support regulatory inspections and audits, including FDA or other health authority inspections, as required.
Assist with investigational product and device accountability and reconciliation at clinical sites.
Study Close-Out and Operational Support
Support site close-out activities, including database lock preparation and final monitoring visits.
Collaborate with project management to support investigator payments and financial tracking.
Uphold ProPharma’s Quality Management System and company values across all assigned responsibilities.
Required Qualifications
Education
Bachelor’s degree in Life Sciences, Health Sciences, or a related field; or
Associate degree with a minimum of 6 years of clinical monitoring experience; or
High School Diploma with a minimum of 8 years of clinical monitoring experience.
Experience
Minimum 4+ years of clinical research monitoring experience, including site initiation, routine monitoring, and close-out visits.
Hands-on experience with EDC systems, source data verification, query resolution, and clinical trial documentation.
Strong understanding of regulatory requirements, informed consent processes, adverse event reporting, and clinical trial compliance.
Skills and Competencies
Fluency in Spanish and English (spoken and written).
Strong knowledge of ICH-GCP, FDA regulations, and clinical trial best practices.
Excellent written and verbal communication skills with the ability to collaborate across multidisciplinary teams.
High attention to detail, strong organizational skills, and ability to manage multiple priorities.
Willingness and ability to travel up to 50%, including overnight and weekend travel as required.
Authorization to work in the United States without sponsorship.
Preferred Qualifications
Experience in In Vitro Diagnostics (IVD) or medical device clinical trials.
Clinical research certifications (e.g., ACRP, SOCRA).
Familiarity with FDA submission pathways including IDE, PMA, and 510(k).
Experience with electronic Trial Master File (eTMF) systems and document management processes.
Why Join ProPharma
ProPharma offers a collaborative, inclusive work environment where employees are empowered to grow professionally while contributing to high-impact clinical programs. All applications are personally reviewed by the recruitment team, and every candidate receives communication regarding their application outcome. Remote work is supported, with hybrid collaboration encouraged where feasible.
Equal Opportunity Statement
ProPharma is an Equal Opportunity Employer committed to diversity, equity, and inclusion. Employment decisions are based on qualifications, merit, and business needs without regard to legally protected characteristics.
Notice: ProPharma Group does not accept unsolicited resumes from recruitment agencies or third parties.
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