Clinical Research Coordinator

Position: Clinical Research Coordinator
Location: West Hollywood, CA 90046

Overview:
The Clinical Research Coordinator (CRC) supports the planning, implementation, coordination, and execution of clinical research studies. Working under the direction of the Principal Investigator (PI), Sub-Investigators, and Clinical Research leadership, the CRC is responsible for ensuring clinical trials are conducted in compliance with study protocols, Good Clinical Practice (GCP), International Council for Harmonisation (ICH) guidelines, HIPAA, FDA regulations, and all applicable federal, state, and local requirements.

The ideal candidate will possess strong organizational skills, attention to detail, and the ability to effectively manage multiple clinical research activities while maintaining high standards of participant care and regulatory compliance.

Key Responsibilities:
Study Coordination & Management

• Assist with the planning, implementation, and execution of clinical research studies.
• Evaluate study protocols and support site feasibility assessments.
• Develop strategies to implement study procedures in accordance with protocol requirements.
• Prepare and submit regulatory documents to Institutional Review Boards (IRBs).
• Participate in investigator meetings and communicate with study sponsors and contract research organizations (CROs).
• Maintain study files and essential regulatory documentation.

Participant Recruitment & Enrollment

• Recruit, screen, and assess potential participants for study eligibility.
• Review medical records and protocol inclusion/exclusion criteria.
• Obtain and document informed consent prior to study-related procedures.
• Maintain participant screening, enrollment, and randomization records.
• Schedule participant visits and coordinate study-related appointments.

Clinical Trial Operations

• Perform protocol-required study procedures and assessments.
• Dispense investigational products according to study protocols.
• Review participant diaries, questionnaires, and compliance documentation.
• Collect, process, batch, and ship biological specimens as required.
• Monitor participant adherence to study requirements and investigational treatments.
• Identify, document, and report adverse events and protocol deviations.

Data Collection & Documentation

• Abstract data from medical records and source documents.
• Complete case report forms (CRFs) and electronic data capture (EDC) systems accurately and timely.
• Resolve data queries and maintain source documentation.
• Ensure confidentiality and data integrity in compliance with HIPAA and regulatory standards.
• Maintain study drug accountability and inventory records.

Compliance & Quality Assurance

• Ensure compliance with GCP, ICH guidelines, FDA regulations, and study protocols.
• Support sponsor monitoring visits, audits, and regulatory inspections.
• Prepare documentation for monitoring visits and inspections.
• Assist with quality assurance and quality control activities.
• Report adverse events and safety concerns according to protocol and regulatory requirements.

Team Collaboration

• Communicate effectively with investigators, healthcare providers, sponsors, and research staff.
• Coordinate with primary care providers and study personnel regarding participant progress when appropriate.
• Participate in team meetings and protocol training sessions.
• Support continuous improvement of research operations and participant engagement.

Qualifications:
Required

• Minimum of 2 years of clinical research experience.
• Strong understanding of clinical research processes and regulatory requirements.
• Excellent written and verbal communication skills.
• Strong organizational, documentation, and time-management abilities.
• Proficiency with Microsoft Office Suite and electronic systems used in clinical research.

Preferred

• Bachelor's degree in a scientific discipline or equivalent combination of education and experience.
• Clinical Research Certification (CCRP or equivalent).
• Medical or scientific background.
• Bilingual Spanish language skills.

Skills & Competencies

• Knowledge of FDA regulations, GCP guidelines, and clinical trial operations.
• Experience with Electronic Health Records (EHR), Clinical Trial Management Systems (CTMS), and Electronic Data Capture (EDC) platforms.
• Ability to manage multiple studies and priorities simultaneously.
• Strong attention to detail and commitment to data accuracy.
• Excellent interpersonal skills and ability to build rapport with study participants and team members.
• Ability to work effectively with diverse patient populations.
• Professionalism, integrity, adaptability, and sound decision-making skills.