Clinical Research Coordinator

Job Description

Job Description

Description:

About Us

At SAON, we support clinical research excellence through collaboration, operational expertise, and a commitment to advancing patient care. We are seeking a highly organized and motivated Clinical Research Coordinator (CRC) to support the day-to-day management of clinical research studies in a hybrid work environment.

This role combines onsite clinical research activities with remote coordination and administrative responsibilities. The ideal candidate is detail-oriented, adaptable, and passionate about clinical research operations and participant experience.

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.

Key Responsibilities

1. Coordinate and manage clinical research studies from startup through closeout
2. Screen, recruit, consent, and manage study participants
3. Coordinate study visits, follow-ups, and study-related procedures
4. Maintain accurate study documentation, source records, and regulatory files
5. Enter and reconcile study data within electronic systems and EDC platforms
6. Prepare and submit IRB documentation, amendments, and study updates
7. Monitor study timelines, enrollment goals, and protocol compliance
8. Communicate with investigators, sponsors, CROs, vendors, and study participants
9. Participate in sponsor meetings, monitoring visits, audits, and training sessions
10. Ensure HIPAA compliance and protection of confidential participant information
11. Support quality assurance activities and regulatory readiness
12. Provide remote support for studies and site operations as assigned

• 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.?