Clinical Research Coordinator
Location: San Juan, Puerto Rico
Employment Type: Full-Time
Position Summary
We are seeking an experienced Clinical Research Coordinator to support the execution of Phase II–IV clinical trials in a fast-paced, patient-focused research environment.
The Clinical Research Coordinator will support participant visits, clinical assessments, study procedures, safety monitoring, documentation, and day-to-day study operations in accordance with study protocols, Good Clinical Practice (GCP), and applicable regulatory requirements.
The ideal candidate has hands-on experience in clinical research, is comfortable working directly with study participants, can manage multiple study activities simultaneously, and demonstrates strong attention to protocol compliance, patient safety, and documentation quality.
Key Responsibilities
- Coordinate participant visits across screening, enrollment, treatment/dosing, follow-up, and study completion.
- Review study protocols, including inclusion/exclusion criteria, visit schedules, procedures, safety requirements, and study-specific expectations.
- Support participant screening and enrollment activities.
- Perform and document study-related clinical assessments and vital signs as trained and delegated.
- Support study-related procedures, including specimen collection, phlebotomy, processing, storage, and shipment according to protocol requirements.
- Support preparation and administration of study-related medications, vaccines, injections, infusions, or investigational products when appropriately trained, delegated, and permitted by applicable credentials and scope.
- Monitor participants before, during, and after study procedures and promptly communicate potential adverse events or safety concerns to the investigator and study team.
- Provide participants and caregivers with clear information regarding study visits, procedures, and expectations.
- Maintain accurate and timely documentation in source records, eSource, study logs, electronic medical records, and clinical research systems.
- Enter and review clinical study data and support resolution of data discrepancies or queries.
- Maintain study files, participant records, regulatory documentation, and other required research documentation.
- Follow patient safety, infection prevention, confidentiality, medication safety, and site quality standards.
- Collaborate closely with investigators, study nurses, research staff, sponsors, CROs, and clinical trial monitors.
- Participate in study trainings, sponsor meetings, monitoring visits, audits, and other study-related activities.
- Support efficient, compliant, and high-quality execution of clinical research studies.
Required Qualifications
- Relevant experience in clinical research, clinical trial coordination, healthcare, or a comparable patient-facing clinical environment.
- Experience supporting clinical study participants and protocol-driven activities.
- Strong clinical assessment and patient-monitoring skills.
- Experience with blood draws/phlebotomy and specimen handling.
- Experience with clinical documentation and electronic medical records or clinical research databases.
- Ability to read, understand, and follow clinical research protocols and technical instructions.
- Strong understanding of patient safety, infection prevention, confidentiality, and documentation standards.
- Excellent organizational skills with the ability to prioritize multiple responsibilities and meet deadlines.
- Ability to work independently and collaboratively within an interdisciplinary research team.
- Willingness to complete Good Clinical Practice (GCP), protocol-specific, and study-required training.
Preferred Qualifications
- Previous experience as a Clinical Research Coordinator, Study Coordinator, Clinical Research Assistant, or similar clinical research role.
- Prior experience working on investigational or industry-sponsored clinical trials.
- Familiarity with FDA, ICH-GCP, and HIPAA requirements.
- Experience with EDC, CTMS, eSource, EMR, or other clinical research systems.
- Experience with participant screening, enrollment, and informed consent.
- Experience documenting or escalating adverse events and safety concerns.
- Experience preparing for or participating in sponsor monitoring visits, audits, or regulatory inspections.
Ideal Background
Candidates may come from clinical research, biomedical sciences, public health, biology, psychology, pharmacy, medical assisting, laboratory sciences, or other healthcare-related backgrounds. A nursing license is not required for this position.
Pay: $40,000.00 - $50,000.00 per year
Work Location: In person
