Irb Assistant Jobs in Puerto Rico (NOW HIRING)

 Location: San Juan, PR | Site Name: CMR Center  | Full-Time  | Clinical Research

We're seeking a Medical Assistant for our clinical research site located in San Juan, PR. This role is ideal for someone with direct patient care experience who is eager to grow in clinical research and support high-quality study execution. The Research Assistant/Medical Assistant will work closely with Clinical Research Coordinators, investigators, study nurses, sponsors, and participants to assist with study preparation, participant visits, data entry, specimen handling, and general clinical research operations. This position requires strong organization, professionalism, attention to detail, and the ability to follow study protocols and Good Clinical Practice guidelines.

Type:  Regular Full-time Employee
Schedule:  Mondays through Fridays, 8:00am - 5:00pm
Location:  Onsite in San Juan, PR (no capabilities for remote or hybrid work)
Benefits:  Our benefits package for full-time employees includes health insurance (medical, dental, and vision), Health Savings Accounts (HSA) and Flexible Spending Accounts (FSA), Paid Time Off (PTO), a variety of disability, accident, and life insurance options, as well as many more.

• Competitive pay + annual performance incentives
• Medical, dental, and vision insurance
• 401(k) plan with company match
• Paid time off (PTO) and company holidays
• A mission-driven culture focused on advancing medicine and improving patient outcomes

You'll be part of a growing, mission-driven organization that values its people. At our core, we're committed to bringing innovative medical treatments to patients faster-while creating an environment where employees thrive. If you're passionate about clinical research and ready to make a difference, we'd love to hear from you.

Responsibilities:

• Study Preparation and Coordination 
  • Prepare and maintain study documents, including source charts, study binders, regulatory binders, laboratory kits, and participant materials. 
  • Schedule and confirm participant appointments, including ancillary visits such as diagnostic imaging, vendor-related services, laboratory visits, and follow-up assessments. 
  • Review and understand study protocols, inclusion and exclusion criteria, visit schedules, and study-specific requirements. 
  • Support compliance with FDA, Sponsor, IRB, and Good Clinical Practice guidelines. 
  • Assist with participant recruitment by prescreening electronic medical records, following up on referrals, and coordinating outreach efforts. 
  • Help prepare for participant visits by ensuring required documents, supplies, kits, and equipment are ready. 
• Participant Care and Interaction 
  • Provide professional, patient-focused support to study participants throughout the clinical trial process. 
  • Explain study visit procedures, answer general participant questions, and escalate clinical or protocol-related questions to the appropriate team member. 
  • Conduct study-related procedures as delegated and trained, including vital signs, ECGs, questionnaires, and other protocol-required assessments. 
  • Monitor participant diary completion and compliance with study instructions. 
  • Perform follow-up and reminder calls to support participant adherence to scheduled visits and study requirements. 
  • Assist with participant stipend tracking and processing. 
• Laboratory and Specimen Handling 
  • Perform blood draws as trained and delegated. 
  • Process biological samples according to protocol and laboratory manual requirements. 
  • Prepare and ship specimens in accordance with study-specific procedures and applicable regulations. 
  • Maintain laboratory supplies, equipment, temperature logs, and temperature control systems. 
  • Generate, review, and file weekly temperature reports for laboratory systems. 
  • Ensure exam rooms, laboratory areas, and clinical supplies are clean, stocked, organized, and ready for participant visits. 
• Data Entry and Documentation 
  • Enter and verify study data in Electronic Data Capture systems, Clinical Trial Management Systems, electronic medical records, and other study databases. 
  • Assist with completion of source documents and case report forms under the guidance of the Clinical Research Coordinator. 
  • Perform quality control checks to ensure data accuracy, completeness, and consistency. 
  • Assist with query resolution and system-generated queries under coordinator supervision. 
  • Maintain organized participant charts, source documents, Investigator Site Files, and other study-related records. 
• Administrative and General Research Support 
  • Support Clinical Research Coordinators by filing, scanning, faxing, copying, and uploading required study documents. 
  • Assist with onsite and remote clinical research monitor visits. 
  • Participate in study trainings, investigator meetings, sponsor teleconferences, and internal team meetings. 
  • Help maintain department supplies, exam rooms, participant areas, and study workspaces. 
  • Support the research team with other duties as assigned based on study and site needs. 

Requirements:

• Bachelor's degree OR two years of college in a health-related program OR completion of a Medical Assistant, Phlebotomy, CNA, or other healthcare-related program OR relevant clinical research experience with knowledge of ICH-GCP. 
• Fluent in English and Spanish (both written and oral) required.
• Experience, certification, or license as a CNA, Medical Assistant (MA), Phlebotomist, or other direct-patient-care healthcare role required. 
• Phlebotomy training and experience strongly preferred; willingness to become fully trained required.
• Experience with medical terminology and laboratory procedures helpful.
• Strong attention to detail with the ability to collect, compile, and review patient data accurately.
• Excellent interpersonal, verbal, written, and customer service skills.
• Ability to learn new computer systems and web-based platforms, including electronic medical records, Electronic Data Capture systems, and Clinical Trial Management Systems.
• Proven ability to prioritize tasks, meet deadlines, and adapt to a fast-paced clinical environment.
• Strong problem-solving skills with a proactive and solution-oriented approach.