Site Research Assistant - McAllen, TX

About the role

The Spanish Bilingual Site Research Assistant supports clinical trial activities in accordance with Good Clinical Practices (GCP), Institutional Review Board (IRB), and all applicable regulatory requirements. This role requires strong attention to detail, the ability to prioritize in a fast-paced environment, and excellent communication skills.

Responsibilities

• Perform EDC data entry and query resolution in a timely and accurate manner.
• Review patient charts and records from the site database to support protocol-required tasks.
• Build and maintain strong working relationships with investigators, clinical staff, and study teams.
• Aid in screening, prescreening referrals, recruiting, and enrolling research participants.
• Manage scheduling of participants, visit scheduling, reminders, and protocol-related procedures.
• Collect participant history and coordinate laboratory requirements and follow-up care.
• Support the informed consent process, ensuring adherence to IRB-approved protocols.
• Promote participant safety by following protocol guidelines and reporting requirements.
• Ensure compliance with Sponsor and company SOPs, policies, and regulatory guidelines.
• Maintain study supplies and support upkeep of the regulatory binder.
• Record (but not obtain) vital signs as required by study protocol.

Qualifications

• Minimum of an associate’s degree or equivalent combination of education and experience.
• At least 1 year of experience in a clinical research setting (preferred).
• Familiarity with clinical trials, GCP principles, and study-specific procedures (preferred).
• Experience with reviewing charts from site databases, prescreening referrals, EDC entry and query resolution, visit scheduling and reminders, maintaining study supplies, and upkeep of regulatory binders.
• Ability to perform required clinical procedures and understand medical terminology.
• High attention to detail and strong organizational skills.
• Ability to collaborate effectively with coworkers, physicians, patients, and study stakeholders.
• Certifications and licenses as required by company, state, country, or regulatory bodies.