Clinical Research Regulatory Coordinator I

Eastern Nephrology Associates•New Bern, NC

just now•Hybrid

About The Position

Eastern Nephrology Associates is seeking a dedicated Clinical Research Regulatory Coordinator I to support clinical research studies. This role involves assisting with the preparation, submission, maintenance, and organization of regulatory documentation in compliance with federal and state regulations, sponsor requirements, and ENA policies. The position supports the ethical and compliant conduct of research under the direction of the Director of Clinical Research and functional oversight from the Principal Investigator, aligning with ENA’s mission, vision, and values.

Requirements

High School Diploma or equivalent required.
Minimum of 2–4 years of healthcare and/or clinical research experience, or an equivalent combination of education and experience.
Ability to maintain confidentiality of sensitive patient, research, and organizational information.
Strong organizational and recordkeeping skills with attention to detail.
Ability to manage multiple tasks and meet deadlines.
Effective written and verbal communication skills.
Proficiency with personal computers and standard office software, including Microsoft Office and email systems.
Ability to follow established policies, procedures, and direction.
Ability to work independently and collaboratively in a fast paced environment.
Demonstrated professionalism and ability to model ENA’s mission, vision, and values.
Hearing, balancing, handling, and talking and requires full range of body motion.
Visual acuity sufficient for computer and document review (corrected or uncorrected).
Reaching, grabbing, holding – fine motor skills with dexterity and eye-hand coordination.
Lift or move up to 30 pounds.
Primarily administrative and office based work.
Prolonged periods of sitting and working at a computer.
Frequent use of hands for keyboarding and document handling.
Occasional lifting or moving of materials up to 30 pounds using appropriate ergonomic techniques and equipment.
Valid driver’s license and reliable transportation required.

Nice To Haves

Paralegals strongly encouraged to apply.
Associate’s degree (AA) in healthcare, science, or a related field preferred.
Prior experience supporting regulatory activities in a clinical research environment.
Familiarity with Good Clinical Practice (GCP) and basic regulatory requirements.

Responsibilities

Assist with the collection, preparation, and maintenance of regulatory documents for assigned clinical research studies.
Assist with regulatory components of study startup activities, including collection of investigator and site documentation.
Support ongoing regulatory maintenance throughout the study lifecycle.
Maintain accurate, complete, and organized regulatory binders and electronic regulatory files.
Track required regulatory documentation and ensure timely updates and renewals as directed.
Assist with the preparation and submission of IRB applications, amendments, continuing reviews, reportable events, and study closures under supervision.
Track IRB approvals, correspondence, and submission deadlines.
Communicate submission status to research leadership and study staff as appropriate.
Support compliance with Good Clinical Practice (GCP), International Council for Harmonisation (ICH), FDA regulations, and ENA policies and procedures.
Assist with internal monitoring activities, audits, and inspections by organizing regulatory documentation and responding to requests as directed.
Escalate potential regulatory or compliance issues to the Director of Clinical Research or Principal Investigator.
Perform other related duties as assigned to support the Research Department.