Clinical Research Coordinator - II

CARE Institute, LLC | Mid-Level | Full-Time | Hourly

About CARE Institute:

CARE Institute (CardioRenalInstitute.com) is dedicated to providing quality clinical research that significantly impacts the health of patients and communities. Our mission is to advance scientific and medical knowledge within the industry. With a focus on growth and innovation, CARE Institute offers a dynamic environment with ample opportunities for professional development and career advancement. Join us at CARE Institute and be part of a dynamic team dedicated to making a meaningful difference in clinical research and healthcare. Apply now to embark on an exciting career journey with us!

CARE is proud to be an Equal Opportunity Employer that values and treasures Diversity, Equity, and Inclusion. We are committed to creating an environment of dignity and respect for all our employees, patients, and families (EEO/AA).

Position Summary

The Clinical Research Coordinator II (CRC II) is a mid-level position responsible for independently managing all aspects of assigned clinical trials, ensuring protocol compliance, ethical conduct, and adherence to regulatory standards. The CRC II manages multiple studies simultaneously and serves as lead CRC on assigned protocols. This role requires demonstrated proficiency in clinical research operations, the ability to work independently with minimal oversight, and readiness to begin supporting the development of junior team members. The CRC II works collaboratively with the Recruitment Specialist, Regulatory Specialist, and Site Manager to maintain high-quality trial execution across the site.

Responsibilities

Clinical Trial Operations

• Independently supervise study site activities and ensure adherence to protocols, ethical standards, and regulatory requirements
• Serve as lead CRC on assigned studies, managing daily activities and monitoring subject and researcher activities
• Screen potential study participants through medical record reviews, interviews, and healthcare provider follow-ups
• Perform medical procedures, including but not limited to: patient vitals, phlebotomy, lab processing, and EKGs
• Independently manage interactions with trial compliance monitors, answering all queries and making necessary corrections
• Identify and escalate potential safety issues promptly; contribute to root cause analysis when deviations occur
• Dispense medication upon provider approval and maintain drug accountability records per protocol and FDA guidelines
• Manage patient care and collection of medical history, medications, and data necessary for conducting clinical trials

Documentation & Data Management

• Review and validate source documents while adhering to protocol requirements independently
• Ensure proper transmission of clinical case data to data management centers; review case report questions and resolve or escalate data discrepancies
• Maintain research records of study activity including case report forms and regulatory forms per FDA guidelines
• Demonstrate thorough knowledge of informed consent requirements and ensure all documentation is completed accurately per regulatory and ethical standards
• Understand and independently apply regulatory documentation requirements
• Maintain high data quality standards with timely query resolution in EDC systems

Team Development & Collaboration

• Assist with onboarding and orientation of new CRC I team members
• Provide guidance and support to CRC I staff on day-to-day study procedures
• Collaborate effectively with Regulatory Specialists, Recruitment Specialists, and Principal Investigators
• Participate in preparation for sponsor monitoring visits and assist in resolving audit findings

Site & Administrative Operations

• Ensure all study equipment is in good working order; coordinate maintenance and calibration
• Maintain supplies inventory, anticipate needs, and manage ordering processes
• Provide comprehensive patient education on all trial details
• Process, package, and ship laboratory specimens per protocol and IATA regulations
• Support front office duties as needed including scheduling, reminder calls, and patient tracking
• Maintain cleanliness and organization of patient care, lab, and equipment areas
• Maintain confidentiality of patient PHI, sponsor confidential information, and CARE confidential information
• Other duties as assigned

Skills & Qualifications

• Strong written and oral communication skills
• Demonstrated ability to manage multiple studies simultaneously with minimal oversight
• Superior problem-solving, deductive reasoning, and decision-making skills
• Ability to build and maintain effective relationships with colleagues, sponsors, and monitors
• Strong time management skills with ability to prioritize competing demands efficiently
• Knowledge of statistical data collection, validation, editing, and analysis techniques
• Ability to provide technical guidance and support to CRC I staff
• Knowledge of laboratory certification processes and standards
• Excellent attention to detail with strong record-keeping skills
• Proficiency with Microsoft Office, Adobe Acrobat, and clinical trial management systems (e.g., Clinical Research IO)
• Strong knowledge of medical terminology
• Professionalism, reliability, and strong interpersonal skills
• Demonstrates initiative and ability to work independently

Education & Experience Requirements

• High school diploma or equivalent education required
• Minimum of two years of experience as a Clinical Research Coordinator
• Must have two years of experience as a Medical Assistant or have obtained a Certified Medical Assistant degree
• Must be proficient in performing EKGs, blood collection, obtaining vitals, and documenting medical history
• Served as lead CRC on a minimum of 4 studies (cumulative)
• CCRC certification preferred; must be actively pursuing or have a plan to obtain within 24 months
• Valid driver’s license and current automobile insurance

Physical Demands

The employee must have the ability to lift, pull, push, and manipulate equipment and patients, which requires strength and gross motor and fine motor coordination. The employee must be able to administer prescribed treatments. The position requires sitting and/or standing for long periods of time and the ability to operate a computer.

Position Details

• Job Type: Full-time, Hourly, Monday to Friday, In Person
• Salary Range: $22–$29/hr depending on experience
• Benefits: 401(k) with matching, Paid Time Off, Health Insurance, Bonus eligibility

Pay: $22.00 - $29.00 per hour

Benefits:

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

Experience:

• Clinical research: 2 years (Preferred)

Work Location: In person