Lead Clinical Research Coordinator (CRC)
The Clinical Research Coordinator (CRC) is a specialized research professional working with, and under the direction of the clinical Principal Investigator (PI). The CRC supports, facilitates, and coordinates the daily clinical trial activities, including participant recruitment, data collection, ensuring compliance with ethical and regulatory standards, and coordinating with various stakeholders to facilitate the smooth execution of a study.
Key Responsibilities of a Lead Clinical Research Coordinator
Participant Recruitment and Screening
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Identifying and screening potential study participants
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Scheduling and conducting study visits
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Obtaining informed consent
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Registering study participants for the appropriate clinical trial
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Reviewing inclusion and exclusion criteria with the Principal Investigator
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Developing strategies to retain subjects in the research study
Administrative, Management, and Data Collection
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Assisting with study feasibility assessments
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Attending Site Qualification, Initiation, and Close-out meetings
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Participating in Investigator's meetings as requested
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Completing study-specific training
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Finalizing regulatory documents
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Preparing IRB submission documents (FDA1572, FDFs, ICFs)
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Establishing and organizing study files
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Preparing study source documents for data collection
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Creating billing sheets
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Maintaining participant records, study accountability logs, and documentation of training
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Keeping an adequate inventory of study supplies
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Conducting study procedures and collecting data according to protocol
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Entering accurate data into EDC
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Monitoring and documenting any adverse events experienced by participants
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Tracking study progress to ensure compliance with research protocols, regulatory guidelines, and ethical standards
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Assisting monitors during on-site and remote monitoring visits
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Participating in study audits
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Liaising with investigators, sponsors, and CROs to facilitate smooth project execution
Laboratory Proficiency
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Processing blood samples according to the study laboratory's guidelines
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Packing and shipping specimens within the specified time frame
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Receiving, storing, and dispensing the Investigational Product
Skills
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Strong organizational and project management skills
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Excellent communication and interpersonal abilities
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Detail-oriented with a high level of accuracy in data collection and management
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Knowledgeable in research methodologies, ethical principles, and regulatory compliance
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Capable of working independently as well as part of a team
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Background in healthcare or experience in clinical research
Qualifications
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Bachelor's degree with 3 years of relevant experience or an equivalent combination of education and training
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Advanced knowledge of Good Clinical Practices (GCP) principles
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Skill in performing required clinical procedures such as phlebotomy and ECGs
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Strong understanding of medical terminology
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Proficient in using technology
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Ability to work independently, actively prioritize, seek input, solve problems, and collaborate in a team environment
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Ability to maintain confidentiality
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Ability to establish and maintain effective working relationships with coworkers, managers, and clients
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Certification as a CCRC or CCRP preferred
Benefits
Work Remotely No
Job Type: Full-time
Salary: $75,000 - $95,000
Schedule: 8-hour shiftMonday to Friday
Work Location: In person
Why Join Us
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Over three decades of excellence in patient care
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Competitive salary and benefits package
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Enjoy living in Napa Valley
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Supportive work environment
About Neurovations Research:
At Neurovations Research, our leadership embodies a commitment to excellence and an unwavering dedication to advancing the fields of neurology and healthcare innovation. Guided by a visionary team, our leadership sets the standard for cutting-edge research and compassionate patient care. Their deep expertise and passion for discovery drive us to push the boundaries of knowledge in pain management, neurologic diseases, and beyond. With a foundation of over three decades of experience, our leadership fosters a culture of collaboration, innovation, and rigorous inquiry, enabling us to explore new horizons in the realm of neurological research and bring hope and healing to countless lives.