Clinical Research Coordinator

Position Summary:
The Clinical Research Coordinator (CRC) is a specialized research professional that facilitates and coordinates the daily activities of a clinical trial and plays a critical role in the conduct of the study. The CRC conducts clinical trials using good clinical/scientific practices under the auspices of the Principle Investigator and in collaboration with clinical departments and sponsors. The CRC is responsible for managing clinical trials from initiation through closure which can include coordinating study development; feasibility evaluation and preparation; IRB submission; recruiting subjects and assessing subject eligibility; reporting of adverse events; data collection and reporting; maintaining regulatory documents; assisting with study modifications; and completing case report forms.

Qualifications:
EDUCATIONAL REQUIREMENTS
Bachelor's Degree in Bachelors Science and/or Bachelors Health or Experience in Lieu of Education - Five (5) years of clinical trials research or healthcare related experience.

CERTIFICATION & LICENSURE REQUIREMENTS
Certified Clinical Research Professional SOCRA Certification within 3 years.

SKILLS AND KNOWLEDGE
Competency in medical terminology required. Strong organizational, writing, and speaking skills; able to collect, organize and maintain detailed data; effective interpersonal communication skills; attention to detail; understanding of all applicable research regulatory guidelines. Prefer prior experience coordinating and managing clinical research trials.

Essential Functions:

• Works in collaboration with the Principle Investigator (PI).
• Assists Regulatory Specialist in maintaining regulatory documents.
• Conducts protocol and feasibility evaluation.
• Assesses patient population, recruitment and enrollment strategies.
• Recruits and manages trial subjects to include screening patients for protocol eligibility, covering informed consent, screening and inclusion/exclusion of the subjects adhering to safety and compliance issues.
• Performs and/or coordinates tissue processing and subject's participation in clinical diagnostic procedures.
• Assists with maintenance of research related inventories for approved studies.
• Assists in accurate and timely data collection, collection of source documents documentation, data entry, and reporting.
• Schedules, coordinates planning and participates in monitoring and auditing activities.
• Participates in required training and education programs.
• Assists PI in development of materials and tools necessary to appropriately train individuals involved in the conduct of the study around issues related to but not limited to, protocol requirements, schedule of subject visits, execution of research plan. Maintains documentation of training.
• Retains all study records in accordance with sponsor requirements.
• Maintains effective and timely communications with sponsor, research subjects and PI during the course of the study.
• Provides a safe environment for patients, families, and clinical staff at all time through compliance with all federal, state, and professional regulatory standards.
• Reports instances of noncompliance to appropriate institutional oversight body.
• Maintains strict patient confidentiality according to HIPAA regulations and applicable law.
• Follows all clinical procedures and guidelines as set forth by regulatory body.
• Close-out of the clinical trial, contributing to research article, audit preparation, trial closure, communication with authorities and other disciplines involved, assisting in the final study report, completing financial obligations and archives study materials.
• Recognize potential obstacles and work to resolve them within set timelines.