Clinical Research Coordinator

Job Type

Full-time

Description

SUMMARY

The Clinical Research Coordinator (CRC) is responsible for managing and coordinating all aspects of clinical research studies conducted within the organization. This role ensures compliance with study protocols, regulatory requirements, and ethical standards while supporting investigators and research teams in delivering high-quality data and patient care. The CRC recruits and screens study participants, obtains informed consent, schedules and conducts study visits, collects and maintains accurate research data, and serves as a key liaison among sponsors, investigators, and clinical staff. Strong organizational skills, attention to detail, and the ability to manage multiple projects simultaneously are essential to success in this role.

QUALIFICATIONS

• RN, MA, LPN, or other medical license/certification required
• Clinical trial/research experience required
• Bachelor's, master's, or other advanced degree in healthcare preferred

Requirements

KNOWLEDGE, SKILLS AND ABILITIES:

• Holds themselves accountable and takes ownership of their job duties
• Ability to relate sensitively to patients' needs
• Excellent verbal and written skills; strong customer service expertise
• Maintains confidentiality by being discrete and using sound judgment
• Ability to establish credibility with physicians, staff, and patients
• Ability to multi-task; resourceful and well organized; takes initiative
• Always mindful of quality improvement and cost-efficient care
• High energy team player who maintains a positive attitude toward providers, peers and patients

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Screen & enroll subjects in studies & manage their participation according to ethical, regulatory, & protocol-specific requirements
• Obtain informed consent from trial subjects before performing any study related procedures
• Develop organizational aids & checklists to facilitate patient recruitment and the collection of complete & accurate study data
• Maintain the regulatory and study files for each research project
• Communicate with the Ethics Committee as appropriate
• Assure proper handling of the investigational product
• Report adverse events to the IRB and sponsor, as appropriate
• Meet with sponsor representatives to discuss planned and ongoing studies
• Oversee study start up through closure and reporting of results
• Participate in quality assurance activities of the sponsor, other regulatory, and accrediting agencies
• Supervise other clinical research personnel, as appropriate
• Participate as appropriate in the training of individuals recruited as members of the research team
• Manage the business aspects of studies, including developing and negotiating study budgets, facilitating the contract review process to assure that provisions on publication, intellectual property, indemnification, records retention, and data ownership are appropriately negotiated with the sponsor
• Design appropriate recruitment strategies and track study enrollment
• Accurate and timely data entry