Clinical Research Coordinator (CRC/CCRC)

Job Description

Job Description

Clinical Research Coordinator (CRC/CCRC)

Position Summary

High Desert Heart and Vascular is seeking a highly organized and detail-oriented Clinical Research Coordinator (CRC/CCRC) to oversee and coordinate clinical research studies conducted at our site. The Clinical Research Coordinator is responsible for the day-to-day management of clinical trials, ensuring compliance with study protocols, Good Clinical Practice (GCP), FDA regulations, sponsor requirements, and institutional policies. This position serves as a key liaison among patients, investigators, sponsors, and regulatory agencies while ensuring the highest standards of patient care and research integrity.

Essential Duties and Responsibilities

Study Coordination

• Coordinate and manage clinical research studies from study start-up through closeout.
• Schedule and conduct study visits according to protocol requirements.
• Ensure protocol adherence and participant safety throughout study participation.
• Coordinate laboratory testing, diagnostic procedures, and other protocol-required assessments.
• Assist investigators in identifying and evaluating eligible study participants.

Participant Recruitment and Retention

• Recruit, screen, and enroll study participants according to inclusion and exclusion criteria.
• Obtain and document informed consent in compliance with regulatory requirements and GCP guidelines.
• Educate participants regarding study procedures, risks, benefits, and expectations.
• Maintain ongoing communication with participants to promote study compliance and retention.

Regulatory Compliance

• Ensure compliance with FDA regulations, ICH-GCP guidelines, HIPAA requirements, sponsor protocols, and site standard operating procedures.

Data Collection and Documentation

• Collect, review, and accurately document source data.
• Enter study data into electronic data capture (EDC) systems within required timelines.
• Resolve data queries and discrepancies promptly.
• Maintain participant confidentiality and data integrity.

Sponsor and Site Communication

• Serve as the primary point of contact between sponsors, contract research organizations (CROs), investigators, and study participants.
• Coordinate sponsor monitoring visits, audits, and inspections.
• Participate in investigator meetings, site initiation visits, and study-related training.

Investigational Product Accountability

• Maintain accountability records for investigational drugs and devices, if delegated.
• Coordinate receipt, storage, dispensing, return, and destruction of investigational products according to protocol and regulatory requirements.

Quality Assurance

• Ensure research activities meet quality standards and regulatory requirements.
• Participate in internal audits and quality improvement initiatives.
• Identify and address protocol deviations and compliance concerns.

Qualifications

Education

• Associate's or Bachelor's degree in Nursing, Life Sciences, Health Sciences, Public Health, or a related field preferred.
• Equivalent clinical research experience may be considered.

Experience

• Minimum of 1-3 years of clinical research experience preferred.
• Experience coordinating industry-sponsored clinical trials strongly preferred.
• Cardiology clinical research experience preferred but not required.

Certifications

• Current CCRC (Certified Clinical Research Coordinator) or CCRP (Certified Clinical Research Professional) certification preferred.
• Certification may be required within a specified timeframe after hire.

Required Knowledge, Skills, and Abilities

• Strong understanding of ICH-GCP guidelines and FDA regulations.
• Knowledge of clinical research processes and regulatory requirements.
• Excellent organizational and time-management skills.
• Strong verbal and written communication skills.
• Ability to manage multiple studies and deadlines simultaneously.
• Proficiency with electronic medical records, Microsoft Office Suite, and EDC systems.
• Ability to work independently and collaboratively within a multidisciplinary team.
• Strong attention to detail and commitment to data accuracy and patient safety.

Physical Requirements

• Ability to sit, stand, and walk for extended periods.
• Ability to use computer equipment and standard office technology.
• Ability to occasionally lift up to 25 pounds.

Why Join High Desert Heart and Vascular?

• Opportunity to contribute to innovative cardiovascular research.
• Collaborative and patient-focused environment.
• Professional development and certification support.
• Competitive compensation and benefits package.

Job Type: Full-Time
Department: Clinical Research
Location: High Desert Heart and Vascular