Clinical Research Coordinator

Benefits

Job Description

Qualifications

• •Bachelor's degree in biology, chemistry, human sciences, or a related scientific field; relevant clinical experience may substitute
• •2-5 years of healthcare and/or clinical research experience
• •Strong attention to detail and organizational skills
• •Excellent written and verbal communication
• •Ability to manage multiple studies concurrently
• •Proficient in basic computer applications
• •Demonstrates honesty, integrity, and professionalism
• •Effective team player in a high-performance environment

Benefits

• •Compensation: $50,000 - $70,000 Annually
• •401(k) and 401(k) matching
• •Health, dental, and vision insurance
• •Life and disability insurance (short-term and long-term)
• •Flexible spending accounts (FSA)
• •Health Savings Accounts (HSA)
• •Employee Assistance Program (EAP)
• •Paid time off (PTO) and holiday pay
• •Wellness programs

Responsibilities

• •In this pivotal role, you will maintain a neat and professional appearance, demonstrate commitment to serve at all times, uphold guidelines as set forth in the employee handbook, and maintain patient confidentiality at all times
• •The Clinical Research Coordinator is involved in all aspects of clinical trials research from pre-study planning to study completion, and includes direct involvement in case management of study participants
• •Works under the supervision of the Principal Investigator and Site Manager
• •Own end-to-end management and execution of all clinical research activities
• •Independently conduct and complete study visits, including protocol review with the Principal Investigator
• •Lead patient recruitment and retention initiatives and support internal study marketing efforts
• •Ensure compliant informed consent before any study procedures
• •Review medical records and eligibility criteria with investigators or site leadership
• •Perform safety assessments (e.g., vitals, venipuncture, ECGs)
• •Create, maintain, and complete source documentation and regulatory binders
• •Schedule subjects, manage follow-up, and coordinate with physicians and sponsors
• •Collaborate with clinical teams to ensure protocol adherence and documentation accuracy
• •Complete CRFs and manage queries in a timely, compliant manner
• •Coordinate research operations across multiple studies, phases, and therapeutic areas
• •Complete and maintain training in ICH/GCP, HIPAA, SOPs, IATA, and other required technical skills
• •Understand Investigator and Site responsibilities under FDA, DHHS, and OHRP regulations
• •Knowledgeable of the drug development process (IND to NDA, IDE to PMA, Phases I-IV)
• •Comprehend and communicate informed consent elements per the Declaration of Helsinki
• •Understand IRB regulations and their role in clinical trials
• •Identify and report adverse and serious adverse events promptly
• •Participate in site initiation, monitoring, and closeout visits, as well as sponsor meetings
• •Engage in peer review of data quality
• •Adhere to company policies and procedures
• •Maintain regular attendance as an essential job function