Job Summary

The Clinical Research Coordinator (CRC) is primarily responsible for clinical research activities ensuring compliance with Code of Federal Regulation (CFR) Title 21, The Spine Network (TSN) Quality Program, and Good Clinical Practice (GCPs). The CRC is responsible for the day-to-day management of clinical trials, ensuring research studies run smoothly by consenting eligible participants, collecting accurate data, monitoring participant safety, and upholding compliance with regulatory guidelines, all while working closely with Sponsor and study sites to adhere to the study protocol and ethical standards throughout the research process.

Supervisory Responsibilities: None.

Duties/Responsibilities:

Study Compliance and Coordination

1. Ensure all study procedures adhere to protocols, organizational policies, and regulatory guidelines
2. Stay updated on and apply GCP standards and Institutional Review Board (IRB) requirements

Participant Management

1. Identify and screen potential study participants through medical record reviews and interviews
2. Obtain and document informed consent, clearly explaining study procedures and potential risks
3. Coordinate and conduct study visits, including collecting and processing samples, administering questionnaires
4. Record accurate data from study visits, including patient demographics, medical history, and study-specific measurements

Regulatory and Documentation

1. Prepare and manage study-related documents, including protocol worksheets, IRB submissions, adverse event reports, and progress updates
2. Maintain and review the Trial Management File (TMF) and other regulatory documentation as necessary

Data and Quality Oversight

1. Monitor and record study data accurately, ensuring compliance with study protocols and reporting guidelines
2. Prepare for and participate in quality assurance audits conducted by sponsors, federal agencies, or internal review groups

Collaboration and Communication

1. Coordinate with investigators, healthcare professionals, and study team members to ensure seamless study execution
2. Build and maintain relationships with investigators, site staff, vendors, and contractors
3. Review and address protocol issues, proposing resolutions or updates when required

Additional Responsibilities

1. Participate in continuing education and to maintain professional competency
2. Perform other duties as assigned to support study success

Required Skills/Abilities:

• Familiarity with Electronic Medical Record (EMR) and radiology systems (PACS)
• Strong organizational and time management skills
• ACRP-CP or CCRC certified or willingness to obtain certification
• Attention to detail and accuracy in data collection and documentation
• Proficient in Microsoft Office applications (e.g., WORD, Excel, PowerPoint, Outlook, etc.) and electronic data capture (EDC) platforms
• Excellent communication, written and organizational skills (i.e., ability to prioritize a number of tasks of varying complexity), along with problem solving, and conflict resolution
• Ability to motivate and collaborate with other functional teams and/or departments as necessary
• Ability to work independently, take initiative, and meet TSN goals for study projects within timelines and budget requirements
• Able to function in an environment where multiple competing tasks occur

Education and Experience:

• Bachelor’s degree or equivalent combination of education and/or experience in science or health-related field
• 2 years of experience in clinical research in the medical device and/or pharmaceutical industry with IDE and/or IND experience preferred
• Clinical research experience outside the U.S. is helpful but not required
• Working knowledge of Food and Drug Administration (FDA) regulations and GCP guidelines

Work Environment:

• Prolonged periods of sitting at a desk and working on a computer
• Required to use hands/fingers to type and handle materials
• Must be able to lift up to 15 pounds at times

EEO Statement:

The Spine Network is an equal opportunity employer. All aspects of employment including the decision to hire, promote, discipline, or discharge, will be based on merit, competence, performance, and business needs. We do not discriminate on the basis of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law.

This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.?