Clinical Research Coordinator

KI HEALTH PARTNERS, LLC; New Haven (CT); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

401(k)

Employee discounts

Health insurance

Paid time off

401(k) matching

Dental insurance

Opportunity for advancement

Profit sharing

Vision insurance

Job summary

Ki Health Partners is seeking a Clinical Research Coordinator in New Haven, CT to coordinate daily trial operations and ensure data integrity. You will enroll and follow participants, manage data in EDC/CTMS, and liaise with sponsors and IRBs in a fast-paced, science-driven setting.

The role requires a life sciences degree and 3–5 years of clinical research experience, with knowledge of FDA regulations and IRB processes highly valued.

Qualifications

• Bachelor's degree in life sciences or related field required.
• 3–5 years of clinical research coordination experience preferred.
• Familiarity with FDA regulations, ICH-GCP, and IRB processes a plus.

Responsibilities

• Coordinate and manage day-to-day clinical trial operations in compliance with GCP and regulatory guidelines
• Screen, enroll, and follow up with study participants throughout studies
• Collect, record, and maintain accurate study data using EDC systems
• Serve as primary contact for study sponsors, IRBs, and research staff
• Prepare and submit regulatory documents including IRB submissions and continuing reviews
• Monitor patient safety and report adverse events as per protocol
• Support site initiation visits, monitoring visits, and sponsor audits

Skills

Attention to detail

Strong organizational skills

Excellent interpersonal communication

Regulatory knowledge (FDA/ICH-GCP)

Education

Bachelor's degree in life sciences

Tools

EDC systems

CTMS

Job description

Benefits:

• 401(k)
• Employee discounts
• Health insurance
• Paid time off
• 401(k) matching
• Dental insurance
• Opportunity for advancement
• Profit sharing
• Vision insurance

About the Role:

Ki Health Partners is looking for a passionate and detail-oriented Clinical Research Coordinator to join their growing team in New Haven, CT. This is an exciting opportunity to play a meaningful role in advancing clinical research and improving patient outcomes. If you thrive in a fast-paced, science-driven environment, we want to hear from you!

Responsibilities:

• Coordinate and manage day-to-day clinical trial operations in compliance with GCP and regulatory guidelines
• Screen, enroll, and follow up with study participants throughout the duration of clinical studies
• Collect, record, and maintain accurate study data using electronic data capture (EDC) systems
• Serve as a primary point of contact for study sponsors, IRBs, and research staff
• Prepare and submit regulatory documents, including IRB submissions, amendments, and continuing reviews
• Monitor patient safety and report adverse events in accordance with protocol requirements
• Support site initiation visits, monitoring visits, and audits conducted by sponsors or regulatory agencies

Requirements:

• Bachelor's degree in life sciences, healthcare, or a related field
• Minimum 3-5 years of experience in clinical research coordination or a similar role
• Familiarity with FDA regulations, ICH-GCP guidelines, and IRB processes
• Proficiency with EDC systems and clinical trial management software (CTMS)
• SOCRA or ACRP certification (CCRP or CCRC) preferred
• Strong organizational skills with exceptional attention to detail
• Excellent interpersonal and communication skills for working with patients and multidisciplinary teams

About Us:

Ki Health Partners is a forward-thinking healthcare organization dedicated to driving innovation in clinical research and patient care. Our team is committed to fostering a collaborative, mission-driven culture where every employee's contributions make a real difference. At Ki Health Partners, you'll find a supportive environment that values professional growth, scientific excellence, and meaningful impact.