Clinical Research Coordinator

Job Summary
The Clinical Research Coordinator (CRC) plays a pivotal role in the execution and management of clinical trials and research studies, working closely with principal investigators, research teams, and participants. This position ensures that all processes comply with regulatory, ethical, and organizational standards while contributing directly to the advancement of medical knowledge and patient care.

Duties and responsibilities

• Collaborates with the Clinical Program Manager and physicians to identify, develop, organize, and implement clinical research activities.
• Partners with principal investigators and clinical staff to plan and execute research protocols in compliance with IRB, FDA, and GCP guidelines.
• Maintains data integrity and assists in the development of databases for effective data collection and analysis.
• Oversee proper storage and accountability of investigational products in accordance with study protocols.
• Ensures compliance with all research policies, protocols, and participant protection standards.
• Conducts patient recruitment, screening, consenting, and enrollment in compliance with protocol requirements and ethical standards.
• Coordinates study visits and procedures, ensuring protocol-specific assessments are scheduled and completed on time.
• Tracks and reports adverse events and protocol deviations per regulatory guidelines and sponsor requirements.
• Maintains and updates study records in regulatory binders and clinical trial management systems (CTMS), if applicable.
• Demonstrates strict confidentiality and discretion in all matters related to research studies and participants.
• Apply privacy and safety standards related to job responsibilities and research operations.
• Performs other duties as assigned.

Working conditions

• Works in an office or clinical setting.
• Exposed to moderate noise levels.
• Emphasizes collaboration with various stakeholders.
• Necessitates effective communication and teamwork.
• Functions in a fast-paced environment.
• May require flexibility in working hours.
• Requires adherence to safety protocols and compliance with healthcare regulations.
• Valid driver's license and reliable transportation for travel between locations.

Physical requirements

• Must be able to lift 25 lbs.
• Must be able to sit, stand and walk for extended periods of time
• Must be able to bend, kneel, crawl and twist as needed
• Must be able to see, hear, type, and speak
• Must be able to reach and pull

Qualifications/Education Requirements

• Minimum of 2-3 years of clinical research experience required.
• Associate or bachelor's degree in biological science, healthcare, or related medical/scientific field preferred.
• An equivalent combination of education and relevant experience may be considered.
• Experience with electronic data capture systems (e.g., Redcap, Medidata Rave) preferred.
• Ability to critically evaluate information and apply problem-solving within healthcare and research settings.
• Proficiency in Microsoft Office Suite (Word, Excel, Outlook).
• Strong command of medical terminology and effective oral and written communication skills.
• Ability to read, write, and communicate effectively in English.