Clinical Research Coordinator (CRC) - Mount Kisco, NY

Clinical Research Coordinator (CRC)

The Clinical Research Coordinator (CRC) is responsible for the day-to-day coordination and operational execution of clinical trials conducted within outpatient healthcare settings. The CRC ensures that clinical trials are conducted in accordance with ICH Good Clinical Practice (GCP), FDA regulations, Institutional Review Board (IRB) requirements, Sponsor protocols, and Internal Standard Operating Procedures (SOPs). The CRC serves as the primary operational liaison between study participants, the Principal Investigator (PI), sponsors or Contract Research Organizations (CROs), and internal leadership. The role focuses on ensuring patient safety, regulatory compliance, data integrity, and successful study execution.

The Clinical Research Coordinator reports to operational leadership within the research program. Clinical oversight is provided by the Site Principal Investigator (PI).

Study Start-Up and Site Preparation

• Reviewing study protocols and investigator brochures
• Assisting with site feasibility assessments
• Preparing regulatory binders and study documentation
• Coordinating site initiation visits
• Ensuring required equipment and study supplies are available
• Assisting with IRB submissions and regulatory documentation
• Coordinating staff protocol training

Participant Recruitment and Screening

• Conducting electronic health record (EHR) pre-screening
• Collaborating with clinical staff to identify potential participants
• Coordinating with providers to approach eligible patients
• Explaining study participation requirements
• Scheduling screening and enrollment visits

Informed Consent Process

• Participants fully understand the study
• Risks and benefits are clearly explained
• Written informed consent is obtained prior to any study procedures
• Ensure all consent documentation is completed and maintained in accordance with regulatory standards.

Study Visit Coordination

• Scheduling visits per protocol requirements
• Conducting protocol-required assessments
• Collecting clinical data
• Recording vital signs and medical history updates
• Administering study questionnaires
• Ensuring protocol adherence

Specimen Collection and Handling

• Processing blood and urine samples
• Ensuring proper labeling and documentation
• Preparing shipments according to sponsor laboratory requirements
• Maintaining specimen tracking logs

Data Collection and Documentation

• Maintaining source documentation
• Completing Case Report Forms (CRFs) or electronic data capture (EDC) entries
• Resolving sponsor data queries
• Maintaining regulatory binders and essential documents

Participant Safety Monitoring

• Monitoring participants for adverse events or side effects
• Reporting adverse events to the Principal Investigator
• Ensuring timely reporting to sponsors and IRBs
• Maintaining safety documentation

Sponsor and CRO Communication

• Participating in monitoring visits
• Preparing documentation for audits and inspections
• Responding to sponsor queries
• Providing updates on study progress

Quality Assurance and Compliance

• Maintaining audit readiness
• Ensuring protocol compliance
• Following internal standard operating procedures
• Supporting internal quality reviews

Training and Professional Development

• Maintain required certifications and stay current with clinical research standards.
• Required certifications include: Good Clinical Practice (GCP), CPR Certification, Human Subjects Protection training (CITI or equivalent), Continuing education is encouraged.

Required Qualifications

• Bachelor's degree in health sciences, nursing, biology, public health, or related field
• Minimum of 2 years of clinical research experience required
• Experience working in healthcare or clinical environments
• Knowledge of clinical research regulations and Good Clinical Practice (GCP)
• Bilingual (English and Spanish) is a plus!!