Clinical Research Coordinator

Job Summary

The Clinical Research Coordinator (CRC) is responsible for supporting and managing the daily operations of clinical research studies within a pharmaceutical or medical research setting. This role ensures that all research activities are conducted in compliance with ICH-GCP (International Council for Harmonisation – Good Clinical Practice) guidelines, study protocols, and regulatory requirements. The ideal candidate will demonstrate strong attention to detail, data accuracy, and a commitment to upholding the highest ethical standards in human subject research.

Fluency in English and Spanish is required. Experience in psychiatry or neuroscience research is preferred.

Essential Responsibilities and Duties

· Coordinates all aspects of study implementation, from site initiation to study closeout, under the direction of the Principal Investigator (PI).

· Oversees subject screening, enrollment, informed consent, and ongoing study participation to ensure compliance with study protocols.

· Manages data collection, entry, and verification to maintain accuracy and data integrity across multiple studies.

· Collaborates with pharmaceutical sponsors, contract research organizations (CROs), and monitors to ensure timely communication and regulatory compliance.

· Assists in preparation, submission, and maintenance of regulatory documents, including IRB submissions, source documentation, and case report forms (CRFs).

· Tracks and reports adverse events (AEs), serious adverse events (SAEs), and protocol deviations according to sponsor and FDA requirements.

· Maintains and organizes research files, study binders, investigational product accountability logs, and essential documentation per GCP guidelines.

· Performs study-related procedures such as vital signs, EKGs, phlebotomy, and other clinical assessments per protocol.

· Participates in investigator meetings, monitor visits, and audits to ensure ongoing compliance and data quality.

· Assists with training staff and developing best practices for research and data management.

· Contributes to protocol development, feasibility assessments, and study start-up activities as needed.

· Other research-related duties as assigned by the Principal Investigator or Clinical Operations Manager.

Education / Experience / Skills

· Bachelor’s degree in a scientific, healthcare, or research-related field (preferred).

· 1–3 years of experience in clinical research, pharmaceutical studies, or healthcare (required).

· Experience in psychiatry or neuroscience research preferred.

· Fluency in English and Spanish required.

· Working knowledge of FDA, ICH-GCP, and HIPAA regulatory guidelines governing clinical trials.

· Experience in electronic data capture (EDC) systems, such as Medidata RAVE, REDCap, or similar platforms.

· Strong organizational, time management, and documentation skills with a focus on data accuracy.

· Excellent interpersonal communication skills with patients, staff, and external partners.

· Ability to work independently and collaboratively in a fast-paced, regulated environment.

Job Type: Full-time

Pay: From $60,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Application Question(s):

• Do you have experience in the medical research or pharmaceutical industry?

Language:

• Spanish (Required)

Ability to Commute:

• Hollywood, FL 33024 (Required)

Work Location: In person